Finding a safe and effective vaccine for the treatment of COVID-19 will take at least a year to 18 months. In the meantime, patients need treatment now during this global pandemic. The quickest way to find treatment is to test therapeutic products that are already developed and have potential to treat this particular coronavirus.
Remdesivir is an anti-viral delivered intravenously that works by inhibiting the replication of a virus and was developed by Gilead Sciences to treat patients after the 2014 Ebola outbreak. This treatment for Ebola was abandoned in favor of other products, including vaccines, and its use was never approved by the FDA for any indication. As an experimental anti-viral drug, scientists continued to test how remdesivir performed against other viruses. Pre-clinical tests have shown that remdesivir is effective in treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). The viruses behind SARS and MERS are in the same coronavirus family as COVID-19.
A lack of treatment options for COVID-19 allowed remdesivir to be used through expanded access, commonly referred to as “compassionate use.” This pathway allows for an unapproved drug to be used to treat seriously ill patients when no other treatments are available. Remdesivir has been reported to successfully treat the first case of COVID-19 in the U.S. Emergency access to this promising treatment was made globally available to treat hundreds of patients.
There remains no concrete evidence that proves remdesivir is not only effective in treating COVID-19 patients but also safe for patients to take, especially vulnerable patients such as children and the elderly. The gold standard for making this determination is through performing a randomized, placebo-controlled clinical study.
On February 4th, clinical trials for remdesivir as treatment for COVID-19 began in China. There are now 5 clinical trials taking place to evaluate the safety and effective of remdesivir in participant with COVID-19. Enrollment in a clinical trial is the primary way to receive this potentially beneficial drug. Results of some of these trials may be available as early as April.
Clinical studies are taking place in multiple clinical research locations. For more information on a study or to find a location near you please visit clinicaltrials.gov.
Below is a list of the available clinical studies.
Antiviral Activity of Remdesivir in Participants with Severe Coronavirus Disease
ClinicalTrials.gov Identifier: NCT04292899
Description: 400 participants diagnosed with COVID-19, 18 years or older, will be randomized to two different regimens of remdesivir treatment, either a 5-day or 10-day treatment at a daily 200mg dose.
Study to Evaluate the Safety and Antiviral Activity of Remdesivir
ClinicalTrials.gov Identifier: NCT04292730
Description: 600 participants diagnosed with COVID-19, 18 years or older, will be randomized to three different treatment arms. Placebo treatment, or remdesivir at a 5-day 200mg dose or a 10-day 100mg dose.
Severe 2019-nCoV Remdesivir RCT
ClinicalTrials.gov Identifier: NCT04257656
Description: 453 participants diagnosed with COVID-19, 18 years or older, will be randomized to two different treatment arms, either placebo, or remdesivir.
Mild/Moderate 2019-nCoV Remdesivir RCT
ClinicalTrials.gov Identifier: NCT04252664
Description: 308 participants diagnosed with COVID-19, 18 years or older, will be randomized to two different treatment arms, either placebo, or remdesivir.
Expanded Access Remdesivir
ClinicalTrials.gov Identifier: NCT04302766
Description: Patients treated under expanded access of “compassionate use” are being followed up with to determine if remdesivir was safe and effective.