Vaccine Info

Plaquenil Antiviral Medication

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.

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).

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

Hydroxychloroquine has been studied for the treatment and prevention of coronavirus disease 2019 (COVID-19). The US FDA and the National Institutes of Health state that hydroxychloroquine should only be taken for the treatment of COVID-19 under the direction of a healthcare provider in a clinical study.

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

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

Plaquenil (Hydroxychloroquine) Antiviral Medication Indication

Studies indicate chloroquine was first used as prophylaxis and treatment for 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 for the treatment of hospitalized COVID-19 patients in several countries, but not the USA. Whereas the evidence supporting the use of antimalarial medications for COVID-19 disease is equivocal, the evidence for the use of 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. 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 and; Treatment of 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 emergency use of 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 be effective in treating Covid-19 disease patients.... in a hospital setting.

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.

Side effects of 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.

Also on July 1, 2020, a summary of the U.S. FDA's review of safety issues with the use of 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, and liver problems and failure.

The FDA has published a Frequently Asked Questions document and added that clinical trials studying HCQ to see if these drugs can benefit patients with SARS-CoV-2 coronavirus infection.

Plaquenil (Hydroxychloroquine) Antiviral Medication News

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 21, 2020 - This new report is the third update of a previously published living systematic review (1), focuses on treatment (not 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), respectively. 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 had been questioned for his prescribing of hydroxychloroquine for patients with COVID-19.

October 14, 2020 - TLC announced that the first subject has 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 a small amount of 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 - The combination of Combined metabolic cofactors supplementation and hydroxychloroquine significantly reduced the average complete recovery time compared with hydroxychloroquine and placebo (6.6 days vs 9.3 days, respectively). 

September 24, 2020 - A new 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 treatment and prophylaxis of COVID-19 disease 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 that is independent of previous lymphocyte or eosinophil levels and previous use of systemic or inhaled corticosteroids. To the best of our knowledge, this work is the first instance that this (hydroxychloroquine) prognostic factor has been identified and described.

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 very specific 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 the state of 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 will 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 are all aware the medical community is still learning, researching, and gaining an understanding of the coronavirus. While there are drugs and therapies 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 commissioner of the U.S. FDA declined to take a definitive stance on whether people should take hydroxychloroquine as a treatment for the coronavirus. 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 in 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 selling or 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 in KEM hospital in Mumbai India said 'HCQ is still used in mild to moderate patients in government hospitals after careful scrutiny of medical parameters like ECG test reports and comorbidities. We have not stopped its use entirely, but definitely reduced it.'

July 16, 2020 - A new study found the use of Hydroxychloroquine (Plaquenil) marginally reduced symptoms in outpatients with early, mild COVID-19. At day 14 of the treatment protocol, 24% of participants receiving hydroxychloroquine had ongoing symptoms compared with 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). In addition, 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 was not associated with reductions in 28-day mortality but was associated with an increased length of hospital stay and increased 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 for the prevention and treatment of 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 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 recommendation from the Solidarity Trial’s International Steering Committee to discontinue the clinical trial of hydroxychloroquine, as known as Plaquenil. The interim trial results show that hydroxychloroquine produced little or no reduction in the mortality of hospitalized COVID-19 patients when compared to 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 disease, and without heart-related side-effects, according to a new study published by Henry Ford Health System, which is located 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 and a faster viral load reduction than other treatments.

June 20, 2020 - A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has been stopped by the National Institutes of Health. The data from this study 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 stopped 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 trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend the recruitment of further participants.

June 15, 2020 - The US FDA has concluded that it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating 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, pursuant to section 564(g)(2) of the Act. The oral formulations of HCQ and CQ remain available for providers to prescribe for certain 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 greater 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 for COVID-19, including hydroxychloroquine. We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalized with COVID-19."

June 3, 2020 - The leader of the World Health Organization (WHO) announced it will 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 within 4 days after exposure, reported a new study published by the NEJM. 

May 31, 2020 - The U.S. Government announced it has delivered 2-million doses of Plaquenil Antiviral Medication to the people of Brazil. 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 according to results of a new survey conducted by the Lupus Research Alliance.

May 27, 2020 - Evidence on the benefits and harms of using hydroxychloroquine or chloroquine to treat COVID-19 disease is very weak 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 with a view to helping to 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 trial of hydroxychloroquine 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 which is 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 disease.

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

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 now recommends the use of chloroquine or hydroxychloroquine by all Covid-19 patients, including children, starting in the early stages of infection. They must be prescribed by a doctor 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 in case it does turn out to be 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 it is 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 leader of the U.S. FDA 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 in the treatment of 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 his use of the drug in Galveston, Texas. “I don’t think criticism would be valid. I think it actually helps bolster the argument that medication was effective in preventing 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 disease. This study is enrolling 2,000 adults with mild to moderate COVID-19 in the United States. Hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases 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 for the treatment of 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 the use of these medications 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 results of 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 the use of 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 - Hydroxychloroquine could be considered by healthcare professionals for pediatric patients who are diagnosed with severe COVID-19 disease 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 the use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19 disease. 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 doses of hydroxychloroquine for no more than 10 days, and include a cardiologist in patient assessment and monitoring.

April 20, 2020 - Novartis announced it has 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. The clinical trial drug supply will be provided by Sandoz, 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 health-care 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 apparently increase of 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 prior 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)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with 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 who were 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—to treat patients 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 the donation of a substantial amount of hydroxychloroquine to treat hospitalized COVID-19 patients within Switzerland. The aim of the donation is to enable patients to access a potential treatment while also advancing clinical research in the fight against COVID-19.

April 2, 2020 - Henry Ford Health System to lead 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 pursuant 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 issued a statement 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 the treatment of CPPD, all of which signify its capability to immunomodulate and reduce inflammation. HCQ blocks the activity of T-cells, reduces the release of various cytokines (interleukin-1, interleukin-6, and tumor necrosis factor-alfa). It has also demonstrated to inhibit the activity of matrix metalloprotease in experimental animals. In a double-blinded, prospective six-month trial, HCQ was found to be 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

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned and will be enrolling soon.

One small study reported that hydroxychloroquine alone or in combination with azithromycin (Z-Pak) reduced the detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit.

> Search coronavirus 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 the effect of hydroxychloroquine versus placebo 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 the Efficacy of Hydroxychloroquine and Azithromycin 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.