HHS, DoD tap Quantum Leap Healthcare Collaborative for a phase 2 clinical trial of multiple COVID-19 treatments

The U.S. Departments of Health and Human Services (HHS) and Defense (DoD) have partnered with the non-profit Quantum Leap Healthcare Collaborative on a phase 2 clinical trial to screen multiple potential COVID-19 drugs simultaneously.

Unlike many such trials, which focus on a single drug, this will screen multiple potential drugs simultaneously — something the partners hope will identify the safest and effective treatments for the sickest COVID-19 patients. In collaboration with the effort, the Biomedical Advanced Research and Development Authority (BARDA) and DoD put up $66.5 million for the effort, which will bring three additional investigational treatments into the ongoing trial and double clinical sites from 20 to 40 U.S. locations.

“Through our Operation Warp Speed partnership, we have worked feverishly with private industry to develop and make treatments available to reduce hospitalization, either shortening the length of stay or treating people with mild or moderate COVID-19 infections before they have to be hospitalized,” Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, said. “While we’re making significant progress, treatments to save lives of the sickest patients, such as patients in intensive care or on ventilators, remain an urgent need.”

The San Francisco-based Quantum Leap will run the trial, but all therapeutics will be assessed by a panel of federal and academic experts to determine their eligibility. They seek candidates capable of targeting the body’s response to the virus, have safety and efficacy data to bring to the table, are readily available, and have realistic capabilities to achieve emergency use authorization during the pandemic and produce enough to have an impact quickly.

The partners agreed that such an approach to clinical trials would cost less and be more efficient than the traditional, multiple clinical trials focused on a single drug candidate. It will also allow researchers to compare the candidates immediately, to identify which would be best for specific situations or certain combinations. Otherwise, it will behave much like a normal clinical trial, with a group of volunteers given either a placebo or an experimental product.