NIH invests $155M into Phase 3 clinical trial for repurposing drugs to treat COVID-19 symptoms

Several over-the-counter drugs could potentially find new lives treating COVID-19 symptoms, as the National Institutes of Health (NIH) announced this week that $155 million would be invested into a phase three trial of up to seven self-administered medications to that end.

It will be a large-scale test and enroll up to 13,500 participants beginning sometime in the next few weeks. All will be at least 30 years old, test positive for SARS-CoV-2 and have experienced at least two mild to moderate symptoms of the infection for no more than a week. Under an ACTIV master protocol, these volunteers will have their symptoms charted for a 14-day period, although hospitalization and death will be chronicled for a 28-day period. Long-term symptoms will be assessed 90 days after treatment begins.

“While we’re doing a good job with treating hospitalized patients with severe disease, we don’t currently have an approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home, and reduce the chance of their needing hospitalization,” NIH Director Francis Collins said. “ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial.”

ACTIV, or Accelerating COVID-19 Therapeutic Interventions and Vaccines, is a public-private partnership. This latest trial will be randomized and placebo-controlled, although the list of drugs that will be involved has yet to be finalized. While some drugs currently recommended for treating patients hospitalized with COVID-19 include remdesivir, baricitinib, and corticosteroids, the NIH has stressed that medications capable of being administered at home are desperately needed.

As all drugs involved in this trial will have already been tested in humans, they could be approved for COVID-19 treatment much sooner, if successful. Potentially, this could shave years off approval time for treatments. They will be administered either orally or by inhaler.