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Plaquenil Antiviral Medication

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July 13, 2021
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Plaquenil (Hydroxychloroquine) Antiviral Medication Description

Plaquenil (Hydroxychloroquine) is FDA-approved to treat certain types of malaria and autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis, says the U.S. CDC. 

People with lupus should follow their doctor's guidance and the CDC's safety guidelines for people with compromised immune systems.

Plaquenil (Hydroxychloroquine) is in a class of drugs called antimalarials. Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically, the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1).

Plaquenil (Hydroxychloroquine) is a more soluble and less toxic metabolite of chloroquine, which causes fewer side effects and is, therefore, assumed to be safer.

Plaquenil is a longer-acting medication that can take months to build up in the body and become effective. Conversely, it can also take weeks for the medicine to “leave the body." Although hydroxychloroquine has a longer half-life -- around 40-45 days – than many medications, it is most effective and safe at its prescribed dosage. Therefore, it is important to continue the prescribed dosage unless your prescribing doctor says otherwise, says Lupus.org.

Plaquenil Hydroxychloroquine has been studied for the treatment and prevention of COVID-19. The U.S. FDA and the National Institutes of Health state that hydroxychloroquine should only be taken to treat COVID-19 under a healthcare provider's direction in a clinical study.

On July 1, 2020, the FDA published a review of safety issues using hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19. This includes reports of serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, liver problems, and failure.

There is no evidence taking hydroxychloroquine effectively prevents a person from contracting the SARS-CoV-2 coronavirus or developing COVID-19, so people who are not already taking this medication do not need to start says the FDA.

On November 17, 2020, the American Medical Association rescinded its statement calling for physicians to stop prescribing hydroxychloroquine and chloroquine until sufficient evidence becomes available to conclusively illustrate that the harm associated with use outweighs benefits early in the disease course. Implying that such treatment is inappropriate contradicts AMA Policy H-120.988, “Patient Access to Treatments Prescribed by Their Physicians,” which addresses off-label prescriptions as appropriate in prescribing physicians' judgment. 

Plaquenil® (hydroxychloroquine) is registered in approximately 60 countries under various trade names: Plaquenil®, Quensyl®, and Plaquinol® say Sanofi.

Hydroxychloroquine was granted FDA approval in April 1955. Hydroxychloroquine's Accession Number: DB01611.

Plaquenil (Hydroxychloroquine) Antiviral Medication Indication

Studies indicate chloroquine was first used as prophylaxis and treatment for malaria. Hydroxychloroquine is FDA-approved to prevent and treat certain types of malaria. It has a long elimination half-life of 30–45 days, allowing for weekly dosing when used to prevent malaria and a short 48-hour treatment course when used to treat malaria. 

Chloroquine is a lysosomotropic antimalarial drug that neutralizes lysosomal acidification, thus blocking autophagosomal degradation. Chloroquine use for influenza prevention has been researched for years.

Hydroxychloroquine (Plaquenil) can effectively treat rheumatoid disease manifestations, such as joint pain and rashes; reduce thrombotic events; and prolong survival.

Based on limited in-vitro and anecdotal data, hydroxychloroquine is used to treat hospitalized COVID-19 patients in several countries, but not the USA. Thus, whereas the evidence supporting the use of antimalarial medications for COVID-19 is equivocal, the evidence for using these drugs to treat immune-mediated diseases is not.

On April 7, 2020, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine (Plaquenil) Sulfate Tablets USP, 200 mg treatment uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults treat acute and chronic rheumatoid arthritis in adults.

And, on May 14, 2020, the FDA approved another ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; Treatment of acute and chronic rheumatoid arthritis in adults.

A study published by The Lancet on May 22, 2020, was later retracted for data concerns.

On June 15, 2020, the FDA revoked the Emergency Use Authorization (EUA) for the oral formulations of chloroquine phosphate and hydroxychloroquine sulfate distributed from the Strategic National Stockpile issued on March 28, 2020. The FDA said the drug, along with chloroquine, is unlikely to treat Covid-19 disease patients in a hospital setting effectively.

The U.S. HHS Secretary Alex Azar clarified on June 15, 2020, that hydroxychloroquine remains FDA authorized for various use cases and continues to be evaluated in ongoing clinical studies. Later, on July 1, 2020, the Henry Ford Health System in Detroit, Michigan, published very positive results from the 'Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19' study.

Plaquenil (Hydroxychloroquine) Antiviral Side Effects

Side effects of Plaquenil (hydroxychloroquine) include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy, and neuropathy, neuropsychiatric events, and hypoglycemia.

On July 1, 2020, a summary of the U.S. FDA's review of safety issues using hydroxychloroquine to treat hospitalized patients with COVID-19 was published. This includes reports of serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, liver problems, and failure.

The FDA and the National Institutes of Health state that hydroxychloroquine should ONLY be taken to treat COVID-19 under the direction of a doctor in a clinical study. The FDA has published a Frequently Asked Questions document and added clinical trials studying HCQ to see if these drugs can benefit patients with SARS-CoV-2 coronavirus infection.

Plaquenil (Hydroxychloroquine) Antiviral Ingredients

PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: Dibasic calcium phosphate USP, hypromellose USP, magnesium stearate NF, polyethylene glycol 400 NF, polysorbate 80 NF, corn starch, titanium dioxide USP, carnauba wax NF, shellac NF, black iron oxide NF.

Plaquenil (Hydroxychloroquine) Antiviral Medication News

July 13, 2021 - The Annal of Internal Medicine published Original Research: Evaluation of the Effects of Hydroxychloroquine on Viral Clearance in COVID-19. Thi study concluded HCQ did not affect viral clearance in hospitalized patients with COVID-19. The lack of antiviral effect was not associated with symptom duration, level of viral load, degree of inflammation, or presence of antibodies against SARS-CoV-2 at hospital admittance.

July 1, 2021 - ORIGINAL RESEARCH ARTICLE published by PLOS: Sales of antibiotics and hydroxychloroquine in India during the COVID-19 epidemic: An interrupted time series analysis. Based on our models, COVID-19 likely contributed to about 216 million excess doses (95% CI: 68.0 to 364.8 million; P = 0.008) of total antibiotics and 38.0 million excess doses (95% CI: 26.4 to 49.2 million; P < 0.001) of azithromycin between June and September 2020 (i.e., after the lockdown and until the epidemic peak). HCQ sales peaked in March 2020, reflecting the widespread use of this drug for both prophylaxis and treatment of COVID-19 (+11.1 million doses [95% CI: 9.2 to 13.0 million]; P < 0.001), followed by a slow decline afterward.

May 31, 2021 - A non-peer-reviewed study found 'that when increased doses of co-administered HCQ and AZM were associated with >100% increase in survival. Comparison of absolute with weight-adjusted cumulative doses proves administration of ≥80 mg/kg of HCQ with > 1 gm AZM increases survival in IMV-requiring Covid patients by over 100%. According to our data, HCQ is not associated with prolongation.'

April 25, 2021 - A study found that taking a povidone-iodine throat spray three times a day or the oral drug hydroxychloroquine once daily reduced the likelihood of getting infected by Sars-CoV-2, the virus that causes Covid-19, by over 20%. The study was done by a team of clinician-scientists from the National University Health System, led by Associate Professor Raymond Seet, a senior consultant in neurology at the department of medicine in National University Hospital.

April 22, 2021 - The JAMA published an Original Investigation, Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19. In this randomized phase 3 clinical trial, neither hydroxychloroquine nor lopinavir-ritonavir showed any significant benefit for decreasing COVID-19–associated hospitalization or other secondary clinical outcomes.

April 20, 2021 - The Lupus Foundation stated, 'In pregnant women with lupus, treatment with hydroxychloroquine is linked to a reduced risk of premature labor, high blood pressure during pregnancy, and preeclampsia – a potentially dangerous pregnancy complication.'

April 20, 2021 - While the WHO has advised against hydroxychloroquine as a preventive treatment for the disease linked to Covid-19, the head of the infectious diseases department at Fann Hospital in Dakar, Senegal, Dr. Moussa Seydi, has never stopped using it, in association with another molecule: azithromycin.

April 15, 2021 - This letter advises you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.pharmacygeoff.md on March 22, 2021. FDA has observed that your website offers drug products for sale in the U.S. and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 

March 28, 2021 - Letter to Editor: We read with great interest the paper by Putman et al. The publication reviews data from 45 studies evaluating hydroxychloroquine (HCQ), chloroquine (CQ), anakinra, and anti‐IL‐6 therapies in COVID‐19. Except for anakinra, none of the other therapies decreased the risk of death in hospitalized COVID‐19 patients. 'Most treatment data on HCQ in COVID-19 to date has not shown clinical benefit, and final prevention data from the HERO-HCQ trial (ClinicalTrials.gov NCT04334148), which remains active, will hopefully elucidate the role of HCQ in the prophylaxis of SARS-CoV-2 infections and conclude this chapter.

March 4, 2021 - The Lancet published a correspondence 'Hydroxychloroquine in Hospitalized Patients with Covid-19.' The dose used in the RECOVERY trial, the second-highest after that in the trial conducted by Borba et al., arouses concern because it may have been a disease-aggravating factor negating the therapeutic effect.

March 2, 2021 - The BMJ published a linked systematic review and network meta-analysis (6 trials and 6,059 participants) that found that hydroxychloroquine had a small or no effect on mortality and admission to hospital (high certainty evidence). 

February 8, 2021 - The City reported between March and April 2020, the 250-bed St. Albans home in New York City administered hundreds of doses of the drug combination to at least 62 residents, some of whom had not tested positive for the virus, according to interviews, medical records and other documents reviewed by THE CITY, Columbia Journalism Investigations and Type Investigations for the collaborative MISSING THEM project. Other facilities have acknowledged the use of hydroxychloroquine, including the Long Island State Veterans Home in Stony Brook. New York’s health department did admit in October 2020 that three state-run veterans’ homes used hydroxychloroquine with azithromycin or zinc for COVID-19 patients for up to two months.

January 26, 2021 - Annuals of Internal Medicine: Reported Adverse Drug Reactions Associated With the Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic.

January 21, 2021 - The review, titled “Hydroxychloroquine and COVID-19: a Rheumatologist’s Take on the Lessons Learned” and published in Current Allergy and Asthma Reports, discusses the history of the hydroxychloroquine drug, as well as its uses in rheumatology and as an antiviral before and during the COVID-19 era.

January 19, 2021 - Researchers from Hackensack Meridian Health John Theurer Cancer Center (JTCC), a member of the Georgetown Lombardi Comprehensive Cancer Center Consortium, have published results from a multi-center, retrospective, observational study suggesting a possible role for the use of hydroxychloroquine, an antimalarial agent with antiviral and anti-inflammatory properties, as an outpatient treatment for COVID-19. “The odds ratio of 0.53 means that outpatients treated with hydroxychloroquine had about half the odds of subsequent hospitalization compared to those who didn’t receive the drug, and this finding was statistically significant,” Dr. Ip explained.

January 14, 2021 - The Lancet published a correspondence 'Hydroxychloroquine with or without Azithromycin in Covid-19.'

January 11, 2021 - A Detroit-based clinical trial has quietly ended. Henry Ford Health System officials told Bridge Michigan they could not find enough participants to continue studying whether the drug could treat COVID-19 patients.

January 5, 2021 - People with lupus nephritis (LN) and obesity (a body mass index, or BMI, ≥ 30) may have a greater risk of vision impairment when taking hydroxychloroquine (HCQ). According to a recent study, people with LN and obesity have higher blood levels of HCQ than people with LN who are not obese. High HCQ levels have been linked to retinopathy, an eye disease characterized by damage to the retina resulting in partial or complete vision loss.

December 13, 2020 - New research finds communication, both across a person’s healthcare team and between patients and providers, is highly important to improve eye screenings among children treated with hydroxychloroquine (HCQ). HCQ, also known by the commercial drug name Plaquenil®, is often used to treat adults and children with lupus. Though uncommon, eye disease and vision loss or impairment can result from the treatment, and there is a lack of standardized guidance around eye screenings for children receiving the medication. Although HCQ retinopathy was considered uncommon, a prevalence of 7.5% was described in a recent study making early detection critical. Collaboration between rheumatologists and ophthalmologists is crucial in managing patients on HCQ. 

December 8, 2020 - Review: Current Trends in Analytical Methods for Determining Hydroxychloroquine and Its Application as Treatment for COVID‐19. Several chromatographic and electroanalytical methods are presented systematically and efficiently in understandable language. The use of screening techniques such as electrochemical methods has been regarded as the more advantageous approach for detecting HCQ. The cost‐effectiveness, simplicity, and rapidity of these techniques play a crucial role in HCQ determination.

November 24, 2020 - An open-label, cluster-randomized clinical trial involving asymptomatic coronavirus contacts of patients with polymerase-chain-reaction (PCR)–confirmed COVID-19 Catalonia, Spain, published NEJM on November 24, 2020, were administered postexposure therapy with hydroxychloroquine. This study's researchers concluded: 'it did not prevent SARS-CoV-2 infection, or symptomatic COVID-19, in healthy persons exposed to a PCR-positive case-patient.'

November 9, 2020 - JAMA investigation: Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19. Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day-14. These findings do not support the use of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults.

November 5, 2020 - Study published in The Lancet - Effect of pre-exposure use of hydroxychloroquine on COVID-19 mortality: a population-based cohort study in patients with rheumatoid arthritis or systemic lupus erythematosus using the OpenSAFELY platform. 'We found no evidence of a difference in COVID-19 mortality among people who received hydroxychloroquine for the treatment of rheumatological disease before the COVID-19 outbreak in England. Therefore, the completion of randomized trials investigating pre-exposure prophylactic use of hydroxychloroquine for the prevention of severe outcomes from COVID-19 is warranted.'

October 29, 2020 - Lupus Foundation: Hydroxychloroquine (Plaquenil) and Coronavirus (COVID-19) Questions and Answers.

October 26, 2020 - Study: COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study. Risk stratification-based treatment of COVID-19 outpatients as early as possible after symptom onset using triple therapy, including the combination of zinc with low-dose hydroxychloroquine, was associated with significantly fewer hospitalizations.

October 21, 2020 - This new report is the third update of a previously published living systematic review (1), which focuses on treatment (no prophylaxis) of COVID-19 with hydroxychloroquine or chloroquine. The first and second updates covered evidence available through 1 July 2020 (2) and 1 August 2020 (3). This update evaluates evidence published through September 21, 2020.

October 17, 2020 - Study: Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.

October 16, 2020 - The Texas Medical Board dismissed a complaint against Bellaire, Texas-based Richard Urso, M.D., who was questioned for prescribing hydroxychloroquine for patients with COVID-19.

October 14, 2020 - TLC announced that the first subject had been enrolled in Phase I clinical trial of TLC19 for treatment or prophylaxis of Coronavirus disease 2019 (COVID-19). TLC19 is a proprietary liposomal formulation of small hydroxychloroquine for inhalation. Separately, a review letter was published by ScienceDirect: Inhaled hydroxychloroquine to improve efficacy and reduce harm in the treatment of COVID-19.

October 8, 2020 - Study publishes in the JAMA: Among patients hospitalized with COVID-19, those who received hydroxychloroquine did not have a lower incidence of death at 28-days than those who received usual care.

October 7, 2020 - TLC today announced the receipt of ethical and scientific approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for the Company’s Phase I clinical trial of TLC19 Hydroxychloroquine Liposome Inhalation Suspension for Coronavirus disease 2019. The approval comes following the acceptance of TLC’s investigational new drug application with the Taiwan Food and Drug Administration.

October 5, 2020 - Combined metabolic cofactors supplementation and hydroxychloroquine significantly reduced the average complete recovery time than hydroxychloroquine and placebo (6.6 days vs. 9.3 days, respectively). 

September 24, 2020 - A recent study found HCQ administration is safe for short-term treatment for patients with COVID-19 infection regardless of the clinical setting of delivery, causing only modest QTc prolongation and no directly attributable arrhythmic deaths.

September 21, 2020 - The Lancet study: Hydroxychloroquine was not associated with a preventive effect against SARS-CoV-2 infection in a large group of patients with rheumatological conditions.

August 27, 2020 - The second update of a previously published living systematic review focuses on the treatment and prophylaxis of COVID-19 with hydroxychloroquine or chloroquine. The first update covered evidence available through 1 July 2020 (2); this update evaluates evidence published through August 1, 2020.

August 24, 2020 - Study: The risk of hospitalized infection in patients with systemic lupus erythematosus treated with hydroxychloroquine.

August 21, 2020 - A study shows that eosinophil recovery has a positive prognostic impact in COVID-19 independent of previous lymphocyte or eosinophil levels and previous systemic or inhaled use of corticosteroids. This work is the first instance that this (hydroxychloroquine) prognostic factor has been identified and described to the best of our knowledge.

August 13, 2020 - "The U.S. FDA informed us that it would not grant our request for an emergency use authorization for hydroxychloroquine for a segment of COVID-19 patients meeting precise criteria," said Dr. Adnan Munkarah, Henry Ford's executive vice president and chief clinical officer. 

August 4, 2020 - Less than two weeks after starting the early treatment of COVID-19 cases with hydroxychloroquine, Sertãozinho, a Brazilian municipality located in São Paulo, recorded a decrease in the occupation of Intensive Care Units from 100% to 30%. The data were provided by the city hall and confirmed by the report.

August 3, 2020 - The Henry Ford Health System issued an open letter about its study, saying, "the political climate that has persisted has made any objective discussion about this drug impossible." The health system said in the letter that it would no longer comment outside the medical community on the use of hydroxychloroquine to treat novel coronavirus.

July 31, 2020 - The Texas Medical Board is aware of sometimes conflicting information being published regarding COVID-19 disease. In the past week, there was a widely published claim of a “cure” for COVID-19. As we know, the medical community is still learning, researching, and understanding the coronavirus. While drugs and therapies are being used to treat COVID-19, there is no definitive cure at this time.

July 31, 2020 - A Sound Approach: Hydroxychloroquine Reduces Mortality in Severe COVID-19.

July 30, 2020 - Stephen Hahn, the U.S. FDA's commissioner, declined to take a definitive stance on whether people should take hydroxychloroquine to treat the coronavirus. However,  Dr. Hahn said on NBC's "Today" show, "We had data that when this drug was combined with others, there was some risk associated with that. But the question you're asking me is a decision between a doctor and a patient."

July 30, 2020 - Update Alert 2: Should Clinicians Use Chloroquine or Hydroxychloroquine Alone or Combination With Azithromycin for the Prophylaxis or Treatment of COVID-19?

July 29, 2020 - The State of Ohio Board of Pharmacy rule 4729:5-5-21 of the Administrative Code prohibits all terminal distributors (including prescriber clinics, non-resident pharmacies, and institutional facilities) from dispensing hydroxychloroquine and chloroquine for the treatment or prevention of COVID-19 disease. The Ohio Board retracted this rule on July 30th.

July 28, 2020 - The Pennsylvania Department of Health issued a report that found the Brighton Rehabilitation and Wellness Center in Beaver provided 205 patients with hydroxychloroquine without receiving prior approval.

July 23, 2020 - Study published by NEJM: Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. 

July 20, 2020 - Dr. Hemant Deshmukh, dean of KEM hospital in Mumbai, India, said, 'HCQ is still used in mild to moderate patients in government hospitals after scrutinizing medical parameters ECG test reports and comorbidities. Therefore, we have not stopped its use entirely but definitely reduced it.'

July 16, 2020 - A recent study found the use of Hydroxychloroquine (Plaquenil) marginally reduced symptoms in outpatients with early, mild COVID-19. On day 14 of the treatment protocol, 24% of participants receiving hydroxychloroquine had ongoing symptoms than 30% of patients receiving a placebo.

July 16, 2020 - The results of a study in Spain showed no difference in the mean viral reduction load at day 7 ( –3.37 and –3.44 Log10 copies per milliliter in the control and intervention arm, respectively; difference, –0.07; 95% CI, –0.44 to 0.29). Besides, treatment with hydroxychloroquine marginally reduced the risk of hospitalization (7.1% for the control arm vs. 5.9% for the intervention arm; or shorten the time to complete the resolution of symptoms (12 days for the control arm vs. 10 days for the intervention arm).

July 15, 2020 - A non-peer-reviewed study found patients hospitalized with COVID-19, hydroxychloroquine, were not associated with reductions in 28-day mortality but were associated with an increased length of hospital stay risk of progressing to invasive mechanical ventilation or death.

July 14, 2020 - The Bolivian Senate approved a bill that exceptionally authorizes the preparation, marketing, supply, and use of the chlorine dioxide solution to prevent and treat Coronavirus. Legislators clarified that this law establishes the use of chlorine dioxide for treatment against COVID-19 disease s voluntary and not mandatory.

July 9, 2020 - The U.S. FDA reviewed your website www.pharmaboosters.com on June 23, 2020. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

July 9, 2020 - A study published in The Lancet stated: Recent randomized clinical trials have confirmed that hydroxychloroquine does not reduce mortality of hospitalized patients with severe cases of COVID-19 disease. And the risk of heart-related events is associated.

July 4, 2020 - The WHO announced the acceptance of the Solidarity Trial’s International Steering Committee's recommendation to discontinue the clinical trial of hydroxychloroquine, as known as Plaquenil. The interim trial results show that hydroxychloroquine produced little or no reduction in hospitalized COVID-19 patients' mortality than a standard of care.

July 1, 2020 - Study: Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19. In this multi-hospital assessment, when controlling for COVID-19 risk factors, treatment with hydroxychloroquine alone and in combination with azithromycin was associated with a reduction in COVID-19 associated mortality.

July 2, 2020 - Treatment with hydroxychloroquine reduced the death rate in sick patients hospitalized with COVID-19 and without heart-related side effects in Detroit, Michigan.

June 30, 2020 - Reuters reported the UK's Medicines and Healthcare Products Regulatory Agency reactivated the COPCOV trial, which is a randomized, placebo-controlled trial that is aiming to enroll 40,000 healthcare workers and other at-risk staff around the world and is being led by the Oxford University’s Mahidol Oxford Tropical Medicine Research Unit in the Thai capital, Bangkok. Oxford University’s Professor Nicholas White, who is co-leading the COPCOV trial, said, “Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomized controlled trial. The question of whether (it) can prevent COVID-19 or not remains as pertinent as ever.”

June 25, 2020 - Although this is a retrospective analysis, results suggest that early diagnosis, early isolation, and early treatment of COVID-19 patients, with at least 3 days of HCQ-AZ, lead to a significantly better clinical outcome a faster viral load reduction than other treatments. The mean duration of hospitalization was significantly shorter in the HCQ-AZ group (7.3 days (sd 7) vs. 9.2 (sd 8.1) than in the other treatment groups. The proportion of patients hospitalized for ≥10 days was 3.5% in the HCQ-AZ group and 14.2% in the other treatment groups.

June 20, 2020 - A clinical trial to evaluate hydroxychloroquine's safety and effectiveness for treating adults hospitalized with coronavirus disease 2019 (COVID-19) has been stopped by the National Institutes of Health. This study's data indicate that this drug provided no additional benefit compared to placebo control for the treatment of COVID-19 in hospitalized patients.

June 17, 2020 - WHO expert Ana Maria Henao-Restrepo said investigators at the Solidarity Drug Test had decided to stop recruiting new patients. ”After deliberation, they concluded that the hydroxychloroquine arm is going to be eliminated from the Solidarity Trial,” Henao-Restrepo said at a press conference. In a statement released later on Wednesday, the WHO said the decision was based on evidence from the Solidarity Trial itself.

June 16, 2020 - The UK's Medicines and Healthcare products Regulatory Agency instructed UK clinical trial using hydroxychloroquine to treat or prevent coronavirus (COVID-19) from suspending further participants' recruitment.

June 15, 2020 - The US FDA has concluded that it is no longer reasonable to believe that HCQ and CQ oral formulations may effectively treat COVID-19 disease patients in a hospital setting. Accordingly, the FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19, according to section 564(g)(2) of the Act. The oral formulations of HCQ and CQ remain available for providers to prescribe for specific use-cases.

June 15, 2020 - The US FDA issued an update saying the 'coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of remdesivir.'

June 12, 2020 - This study demonstrated that voluntary HCQ consumption as pre-exposure prophylaxis by HCWs is associated with a statistically significant reduction in risk of SARS-CoV-2. These findings, therefore, highlight the need to examine this association in more significant detail among a larger sample using Randomised Controlled Trials.

June 12, 2020 - Indonesian researchers of the Airlangga Public University in the East Java provincial capital of Surabaya, the National Disaster Mitigation Agency, and the State Intelligence Agency announced they identified 5 drug combinations that could potentially treat infected patients with the SARS-CoV-2 coronavirus.

June 9, 2020 -  Study: Hydroxychloroquine inhibits trained immunity - implications for COVID-19 

June 5, 2020 - Professor Peter Horby and Professor Martin Landray, chief investigators of the RECOVERY Trial, said, ‘In March this year, RECOVERY was established as a randomized clinical trial to test a range of potential drugs COVID-19, including hydroxychloroquine. Unfortunately, we have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalized with COVID-19."

June 3, 2020 - The World Health Organization (WHO) leader announced it would resume testing an experimental COVID-19 disease treatment, Plaquenil (Hydroxychloroquine). This drug is FDA-approved to prevent or treat malaria caused by mosquito bites. Dr. Tedros Adhanom Ghebreyesus told an online media briefing he was “especially worried” about the outbreak in Central and South America, where SARS-CoV-2 coronavirus infections have been spreading rapidly.

June 3, 2020 - After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis 4 days after exposure, reported a new study published by the NEJM. 

May 31, 2020 - The U.S. Government announced it had delivered 2-million doses of Plaquenil Antiviral Medication to Brazil's people. This antimalaria drug will be used as a prophylactic to help defend Brazil’s nurses, doctors, and healthcare professionals against the SARS-CoV-2 coronavirus. The United States will also soon be sending 1,000 ventilators to Brazil.

May 29, 2020 - The Lancet published a June 2020 article which summarized its opinion, saying '“Only good science can save us in this pandemic of the new coronavirus; thus we supplicate, leave scientists alone to do their work!”

May 29, 2020 - Sanofi suspends recruitment for coronavirus clinical trials testing hydroxychloroquine over safety concerns.

May 28, 2020 - More than one-third of people with lupus experienced significant issues filling their hydroxychloroquine (Plaquenil) prescriptions during the COVID-19 pandemic of the Lupus Research Alliance.

May 27, 2020 - Evidence on the benefits and harms of using hydroxychloroquine or chloroquine to treat COVID-19 disease is fragile and conflicting.

May 27, 2020 - At Novartis, we remain committed to proceeding with the Novartis HCQ clinical trial to obtain much-needed scientific data. We will continue to monitor other trials and review the medical information on the use of HCQ to help identify the best treatment options for COVID-19 patients.

May 27, 2020 - European Countries Ban Hydroxychloroquine Treatments for COVID-19 Patients.

May 26, 2020 - The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

May 25, 2020 - The WHO temporarily suspended its hydroxychloroquine trial over safety concerns. “The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a news briefing. 

May 24, 2020 - 'We received a letter from the MHRA in which they notified us of their concerns relating to the use of hydroxychloroquine as a treatment for patients with COVID-19 in the light of the recent publication by Mehra et al. in The Lancet on 22 May 2020. We have held two videoconferences with the MHRA and provided a detailed response, summarised below. This morning we have received written confirmation from the MHRA that “it is acceptable to allow continued randomization (of additional patients) into the hydroxychloroquine arm of the trial.'

May 23, 2020 - Vizient, a group purchasing organization that serves about 3,000 hospitals in the U.S., said the demand for hydroxychloroquine in April was about 17 times bigger than in January 2020. Although supply expanded during the period, the volume available last month was only about half of the units ordered.

May 22, 2020 - The Indian Council of Medical Research, India’s apex body in the field, has found that consuming the drug hydroxychloroquine reduces the chances of getting infected with Covid-19.

May 22, 2020 - A study published by The Lancet was retracted because the study authors could not assure the veracity of this observational study's data.

May 20, 2020 - Brazil's Health Ministry issued new guidelines for wider use of antimalarial drug hydroxychloroquine in mild coronavirus cases. With the new guidelines, the health ministry recommends using chloroquine or hydroxychloroquine by all Covid-19 patients, including children, starting in the early stages of infection. A doctor must prescribe them, and patients will have to sign a document saying they understand the risks of taking the medication.

May 20, 2020 - Media reports indicate that the anti-malarial drug hydroxychloroquine is being bought in bulk by the UK if it becomes an effective COVID-19 disease treatment and/or used for prevention purposes. The contract, which was uploaded to a government website on May 15, 2020, is an “open opportunity” for pharmaceutical suppliers to supply more than 33m tablets of various drugs between June and January 2021.

May 20, 2020 - Progenabiome announced starting two FDA-approved clinical trials that include hydroxychloroquine. One clinical trial is for the prevention of COVID-19 disease. The second clinical trial is for the treatment of COVID-19, once infected by the coronavirus.

May 19, 2020 - The U.S. FDA leader said taking the antimalarial drug hydroxychloroquine outside of a hospital is an option. “The decision to take any drug is ultimately a decision between a patient and their doctor,” FDA Commissioner Dr. Stephen Hahn said in a statement to CNBC.

May 19, 2020 - JAMA posted an article which says, 'the US FDA issued a EUA for the use of hydroxychloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19). Hydroxychloroquine has long been FDA-approved for the prophylaxis and treatment of malaria and used to treat systemic lupus erythematosus and rheumatoid arthritis. Although this drug appears to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.

May 14, 2020 -  Dr. Robin Armstrong said he stands by using the drug in Galveston, Texas. “I don’t think criticism would be valid. I think it actually helps bolster the argument that medication effectively prevents others from dying. Out of the cohort we treated, the results were favorable.”

May 14, 2020 - The US NIH begins a phase 2b clinical trial of hydroxychloroquine and azithromycin to treat COVID-19. This study enrolls 2,000 adults with mild to moderate COVID-19 in the United States. Hydroxychloroquine is FDA-approved to prevent and treat malaria and treat the autoimmune disorders rheumatoid arthritis and lupus. Heading the study is Davey Smith, M.D., a translational research virologist, head of Infectious Diseases, and Global Public Health at the University of California San Diego School of Medicine. 

May 14, 2020 - BMJ: Clinical efficacy of hydroxychloroquine in patients with COVID-19 pneumonia who require oxygen: an observational comparative study using routine care data.

May 14, 2020 - Early clinical trials of an antiviral drug Hydroxychloroquine in Russia have given “promising” results in treating the new coronavirus, a joint venture announced Wednesday as Russia faced mounting Covid-19 cases.

May 14, 2020, The U.S. FDA issued an ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; Treatment of acute and chronic rheumatoid arthritis in adults. This Applicant Holder Full Name: HAVIX GROUP INC DBA AAVIS PHARMACEUTICALS.

May 13, 2020 - Phase 2 Clinical Study of Hydroxychloroquine vs. Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy launched by Memorial Sloan Kettering Cancer Center.

May 11, 2020 - The present study suggests a potential interest in the combination therapy using HCQ/azithromycin to treat COVID-19 in in-hospital patients.

May 7, 2020 - Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19, published by the NEJM. These researchers found that patients who received hydroxychloroquine had the same risk of intubation or death as patients who did not receive the malaria drug.

May 7, 2020 - Phase 3 study in Brazil last update.

May 5, 2020 - Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: A retrospective analysis of 1061 cases in Marseille, France.

April 29, 2020 - In the largest reported cohort to date of COVID-19 patients treated with chloroquine/hydroxychloroquine {plus minus} azithromycin, no instances of TdP or arrhythmogenic death were reported. Although these medications' use resulted in QT prolongation, clinicians seldomly needed to discontinue therapy.

April 27, 2020 - In a letter to Gov. Doug Ducey of Arizona, the Association of American Physicians and Surgeons presented an updated table of studies that report treating COVID-19 patients with chloroquine (CQ) and hydroxychloroquine (HCQ, Plaquenil). 'Based on this evidence, we request that you rescind your Executive Orders impeding the use of CQ and HCQ and further order that administrative agencies do not impose any requirements on the prescription of CQ, HCQ, azithromycin, or other drugs intended to treat or prevent coronavirus illness that does not apply equally to all approved medications that may be used off-label for any purpose.'

April 26, 2020 - At least 22 states and Washington, D.C., secured shipments of the drug hydroxychloroquine, according to information compiled from state and federal officials.

April 24, 2020 - FDA cautions against hydroxychloroquine or chloroquine for COVID-19 disease treatment outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems.

April 24, 2020 - Hydroxychloroquine or Chloroquine for COVID-19: FDA Drug Safety Communication.

April 24, 2020 - Brazil’s Federal Council of Medicine has authorized the use of hydroxychloroquine, even though there is no scientific evidence that the drug is an effective treatment for the novel coronavirus.

April 22, 2020 - Healthcare professionals could consider hydroxychloroquine for pediatric patients diagnosed with severe COVID-19 and are not candidates for remdesivir or when remdesivir is not available.

April 21, 2020 - A non-peer-reviewed study, 'Outcomes of hydroxychloroquine usage in United States veterans hospitalized with COVID-19' found no evidence that hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19 disease. In addition, an association of increased overall mortality was identified in patients treated with hydroxychloroquine alone.

April 20, 2020 - Pharmacists Help Weigh Cardiac Risks of Hydroxychloroquine. Cardiovascular side effects are more likely to occur with prolonged therapy at high doses, said Dr. White, so pharmacists should urge providers to stick with lower amounts of hydroxychloroquine for no more than 10 days and include a cardiologist in patient assessment and monitoring.

April 20, 2020 - Novartis announced it had reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. Sandoz, the clinical trial drug supply, will be provided the generics and biosimilars division of Novartis.

April 17, 2020 - The Russian government has authorized hospitals to treat coronavirus patients with the untested malaria drug hydroxychloroquine, which studies have linked to potentially deadly side effects. This decree instructs Russia’s national medical cardiology research center to distribute 68,600 packs of hydroxychloroquine donated by a Shanghai pharmaceutical company to hospitals across Russia for free.

April 17, 2020 - The Indian Council of Medical Research, under the Ministry of Health and Family Welfare, has recommended chemoprophylaxis with hydroxychloroquine (400 mg twice on day 1, then 400 mg once a week thereafter) for asymptomatic healthcare workers treating patients with suspected or confirmed COVID-19, and for asymptomatic household contacts of confirmed cases.

April 16, 2020 - Hydroxychloroquine: The Drug Costa Rica Uses Successfully To Fight Covid-19.

April 14, 2020 - The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than standard-of-care alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects. Adverse events were significantly increased in HCQ recipients, but no apparent increase in serious adverse events. Trial registration ChiCTR2000029868.

April 13, 2020 - The governor of South Dakota announced it is launching the first statewide trial of a possible treatment for COVID-19 in the nation. The drug hydroxychloroquine typically treats malaria, lupus, and rheumatoid arthritis.

April 13, 2020 - The U.S. FDA announced, 'given this public health emergency, and as discussed in the Notice in the Federal Register of April 13, 2020, titled “Product-Specific Guidances; Guidance for Industry,” available at Federal Register - Guidance: Product-Specific Guidances the PSG for chloroquine phosphate, hydroxychloroquine, is being implemented without prior public comment because the FDA has determined that previous public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act and 21 CFR 10.115(g)(2)). Therefore, this guidance document is being implemented immediately, but it remains subject to comment following the FDA’s good guidance practices.'

April 11, 2020 - A new study was performed by researchers at IHU Méditerranée Infection, Marseille, France, of the 1,061 coronavirus infected patients treated entirely with hydroxychloroquine and azithromycin, mortality is around 0.5%, and that the cure rate is extremely high. It avoids worsening and clears virus persistence and contagiously in most cases.

April 9, 2020 - The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

April 8, 2020 - The ORCHID trial (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease), funded by the National Heart, Lung and Blood Institute of the National Institutes of Health, enrolled its first patient on April 2 and will include hundreds of patients to determine if hydroxychloroquine is an effective treatment against the virus projected to hospitalize thousands of U.S. residents in the coming weeks.

April 8, 2020 - Researchers from Intermountain Healthcare and the University of Utah Health in Salt Lake City have launched two vital clinical trials to test the effectiveness and safety of two drugs—hydroxychloroquine and azithromycin with COVID-19 (infection with the novel coronavirus). Researchers from the two health systems plan to enroll nearly 2,300 patients who are COVID-19 positive or suspected of being positive for the virus.

April 7, 2020 - The FDA approved an Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg.

April 3, 2020:  Novartis announced substantial hydroxychloroquine to treat hospitalized COVID-19 patients within Switzerland. The donation aims to enable patients to access potential treatment while also advancing clinical research in the fight against COVID-19.

April 2, 2020 - Henry Ford Health System led a national study to determine the drug's effectiveness in preventing COVID-19 disease.

March 31, 2020:  Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic: What Every Clinician Should Know. American College of Physicians.

March 30, 2020:  No Evidence of Rapid Antiviral Clearance or Clinical Benefit with the Combination of Hydroxychloroquine and Azithromycin in Patients with Severe COVID-19 Infection.

March 30, 2020:  Efficacy of hydroxychloroquine in patients with COVID-19 disease in a randomized clinical trial found the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.

March 30, 2020:  About 83 percent of independent pharmacists in the USA said they should be able to dispense a limited supply of malaria drugs as long the patient has tested positive ..... and is under a doctor's care.

March 29, 2020: Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus, and arthritis drug hydroxychloroquine, plans to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses and is supporting clinical trials needed before the medicine can be approved for use against the coronavirus.

March 28, 2020:  The FDA issued an Emergency Use Authorization for the use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider according to a valid prescription of a licensed practitioner as described in the Scope of Authorization (section II) of this letter.

March 25, 2020:  The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances, Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

March 25, 2020: The WHO urges countries to ensure the continuity of malaria services in the context of the COVID-19 pandemic.

March 22, 2020: India's Secretary of Health stated that the National Task Force for COVID-19 disease officially recommends prophylactic use of hydroxychloroquine for healthcare workers and families of laboratory-confirmed positive COVID-19 patients.

January 7, 2019 - Study: Calcium pyrophosphate disease (CPPD) is caused by the deposition of calcium pyrophosphate (CPP) crystals in the joint tissues, particularly fibrocartilage and hyaline cartilage. Several mechanisms of action have been suggested for Hydroxychloroquine (HCQ) in the context of CPPD treatment, all of which signify its capability to immunomodulate and reduce inflammation. HCQ blocks T-cells' activity, reduces the release of various cytokines (interleukin-1, interleukin-6, and tumor necrosis factor-alfa). It has also been demonstrated to inhibit matrix metalloprotease activity in experimental animals. In a double-blinded, prospective six-month trial, HCQ was beneficial specifically for chronic CPPD-related arthropathies.

August 22, 2005: Chloroquine is a potent inhibitor of SARS coronavirus infection and spread.

March 1, 2015 - HCQ triggers the host defense machinery by inducing ROS- and MAVS-mediated innate immune activation against DENV infection and maybe a candidate drug for DENV infection.

Plaquenil Antiviral Medication Clinical Trials

ClinicalTrial NCT04341441: Will Hydroxychloroquine Impede or Prevent COVID-19 (WHIP COVID-19).

Clinical Trial NCT04332991: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID) (Phase 3).

Clinical Trial NCT04308668: Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) (Phase 3)

Clinical Trial NCT04333654Hydroxychloroquine in Outpatient Adults With COVID-19 (Phase1).Primary Objective: To assess hydroxychloroquine versus placebo effect on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19.

Clinical Trial NCT04321278: Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Phase 3).

Clinical Trials NCT04358068: Evaluating Hydroxychloroquine and Azithromycin's Efficacy to Prevent Hospitalization or Death in Persons With COVID-19.

Note: This content is aggregated from the CDC, WHO, clinical studies, and the Precision Vax news network. This information is fact-checked by healthcare professionals, such as Dr. Robert Carlson.