COVID-19 Update for 3/23/2020

Remdesivir

• Gilead ended a compassionate use program for remdesivir on 3/22/2020 due to overwhelming demand for the drug. Compassionate use may still be requested for pregnant women and children under 18 years of age with confirmed COVID-19 and severe manifestations of disease. The request must be made through the web site. The online form requires information to justify the need for remdesivir.
• Gilead is working with the FDA to implement an expanded access program to provide access to the drug for patients unable to participate in a clinical trial.  The goal is to accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. 
• Gilead has a special expanded use program for patients treated at U.S. military hospitals though NCT04302766.

Delays in Trial Recruitment

The COVID-19 pandemic is causing a delay in recruitment and completion of investigational drug clinical trials. Several pharmaceutical companies have announced delays due to the virus. In some cases new trials are being postponed and in other cases existing trials are being halted or arrangements made to provide study medication to patients. The pool of patients and those willing to volunteer is smaller while the pandemic impacts the health and movement of patients. Healthcare providers and healthcare facilities also have less time and space to use for trials.
 
Chloroquine and Hydroxychloroquine

• Bayer, Novartis and Teva are donating millions of doses of chloroquine and hydroxychloroquine for clinical trials and treatment.
• The FDA wants to see the drugs evaluated in a large clinical trial, before their use becomes a standard practice. 
• Teva, Novartis and Mylan have announced plans to increase production of the drugs.
• Bayer, Zydus Pharmaceuticals, Prasco Labs, Rising Pharmaceuticals and Sun Pharmaceuticals also make the drugs.
• Chloroquine went into shortage on March 9
• Hydroxychloroquine went on shortage on March 19
• The shortage in hydroxychloroquine and chloroquine was due to a large increase in purchases in March

Interleukin 6 (IL-6) Monoclonal Antibodies

• Three Interleukin 6 (IL-6) monoclonal antibodies are being evaluated to reduce lung damage from severe COVID-19 pneumonia.
  • Tocilizumab (Actemra, Roche) is being evaluated in a Chinese trial. Roche and BARDA will compare the effect of tocilizumab to placebo in the Phase III COVACTA trial.
  • Sarilumab (Kevzara, Regeneron, Sanofi) is being investigated by Regeneron and Sanofi in a Phase II/III adaptive trial. The initial phase of the trial will determine the dose to be used in the larger portion of the trial.
  • Siltuximab (Sylvant, EUSA Pharma) is being evaluated in the Italian SISCO trial sponsored by EUSA.
• The IL-6 antagonists are thought to limit lung damage because blocking IL-6 lowers inflammation and prevents cytokine storm in COVID-19 infections.