Gilead implemented an expanded access program for remdesivir in late March for severe COVID-19 patients, over 18, requiring ventilation through NCT04323761. Contact: Gilead Clinical Study Information Center, 1-833-445-3230, GileadClinicalTrials@gilead.com
Remdesivir has been used to treat 1,700 patients through expanded access, compassionate use and clinical trials. Gilead has 1.5 million doses of remdesivir available and will donate the supply for to treat patients at no cost through expanded access, compassionate use and clinical trials. It is estimated the supply would be enough to treat 140,000 patients. Gilead is ramping up manufacturing and plans to have a drug supply large enough to treat 500,00 patients by the end of October and 1,000,000 by the end of 2020 with larger amounts available in 2021 if needed.
The European Medical Agency (EMA) released recommendations on use of remdesivir through compassionate use programs in Europe. The recommendations include a summary of dosing, administration, monitoring and management of patients receiving remdesivir.
Chloroquine and Hydroxychloroquine
In a 62 patient, Chinese trial, the addition of hydroxychloroquine to oxygen therapy, unspecified antiviral and antibacterial agents and immunoglobulin with or without corticosteroids reduced the time to remission, resolved cough, normalized temperature and improved pneumonia compared to placebo in patients hospitalized with COVID-19. (Note: the posted article is on an editorial server and has not been peer reviewed)
The EMA restricted use of chloroquine and hydroxychloroquine to already approved indications to treat malaria and autoimmune diseases, but the drugs can be used by COVID-19 patients through nationally established protocols or through clinical trials.
Chloroquine and hydroxychloroquine are in short supply. The FDA declared a shortage of both drugs in in late March 2020. ASHP has issued recommendations for stewardship of these drugs.
Three Chinese trial are evaluating favipiravir in the treatment of COVID-19.
Moderna estimates it will be able to initiate a Phase II trial for the mRNA-1273 vaccine in late spring or early summer.