This is an area that is developing so fast that I wanted to do a quick update. Besides Remdesivir, trials of another anti-viral treatment for hospitalized patients has yielded a somewhat similar positive result. This time it is a drug cocktail, born not just out of how we learned to combat HIV but including drugs used in that fight. In this trial average time to resolution of symptoms was 7 days vs 12 days for the control group. The cocktail is of existing approved drugs, so in theory doctors could begin using this therapy at any time (i.e. “off label”). By the time Wave 2 hits this fall one or both of these therapies will have much more supporting data and be available in reasonable quantities.

There is another exciting effort going on that was initiated by Steve Kirsch to find early use out-patient treatments. This effort is called the COVID-19 Early Treatment Fund (CETF) and one of the things they point out is that there are currently 700 funded trials of inpatient treatments (i.e., for when you are so sick you are hospitalized) and only 2 for outpatient treatments. So they are trying to raise funds to support trials of outpatient therapeutics, with Kirsch having provided seed funds. I bring this up as part of my Wave 2 thinking because they already have supported one compound that has started trials, peginterferon lambda-1a (“Lambda”). Lambda is a drug that has already been through late stage trials for other indications and has an established safety profile. If trials for Covid-19, including the one  CETF is supporting at Stanford, show efficacy than it could have an accelerated path to approval. Would the FDA use its Emergency Use Authorization powers to make a drug  for treating mild cases on an outpatient basis (and hopefully preventing them from turning into cases requiring hospitalization) quickly available? Or would they require a classic, if accelerated, Phase 3 trial and New Drug Application? That’s probably the difference between if Lambda (assuming it actually works) is available as a tool to combat Wave 2 or not. But both Lambda, and CETF’s broader mission of focusing on near-term early treatment options, are quite promising.