Remdesivir Enters Phase 2 Study For Treating COVID-19 Disease
No therapeutics have been FDA approved to treat patients with COVID-19
A clinical trial to evaluate the safety and efficacy of the investigational antiviral Remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC).
Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment.
It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
Launched on February 21, 2020, this phase 2 clinical trial is the first in the USA to evaluate an experimental treatment for COVID-19, the respiratory disease that is caused by the novel coronavirus SARS-CoV-2.
The first trial participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study.
This study’s regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. And, the study can be adapted to evaluate additional investigative treatments and to enroll participants at other sites in the U.S. and worldwide.
COVID-19 infection can cause mild to severe respiratory illness, and symptoms can include fever, cough, and shortness of breath, according to the Centers for Disease Control and Prevention (CDC).
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D., in a related press release.
“A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
Clinical trials of remdesivir are also ongoing in China.
NIAID developed the current study taking those designs into account, and in accordance with consultations convened by the WHO on the development of a therapeutic trial for patients with COVID-19.
Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation.
Andre Kalil, M.D., professor of internal medicine at UNMC and an infectious disease physician at Nebraska Medicine, is leading the trial at UNMC.
UNMC’s National Quarantine Unit is supported by the office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services.
It has a 20-bed capacity and is in close proximity to the Nebraska Biocontainment Unit, should a higher level of care be needed. Clinical trial participants are cared for in the biocontainment unit.
“We thank the individuals for their participation in this trial, and we are pleased that the NIH has chosen UNMC/Nebraska Medicine as the site for this important work,” said Dr. Kalil.
“Our expertise in treating highly infectious disease — as well as our capacity to conduct leading-edge clinical trials — will ensure that this trial is carried out in the most effective manner possible.”
Currently, there are no specific therapeutics approved by the Food and Drug Administration (FDA) to treat people with COVID-19.
Moreover, no preventive vaccines have been FDA approved to prevent a SARS-CoV-2 infection.
The NIAID conducts and supports research at the NIH, throughout the United States, and worldwide, to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
Coronavirus medication and vaccine news published by Precision Vaccinations.