In the race to identify safe and effective therapeutic treatments for the sickest COVID-19 patients, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) are engaging a non-profit research organization, Quantum Leap Research Collaborative of San Francisco, on a phase 2 clinical trial that rapidly screens multiple potential drugs simultaneously.
“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,” said Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response. “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 Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense on a $66.5 million agreement with Quantum Leap Healthcare Collaborative to add three investigational treatments to the research organization’s platform clinical trial. The agreement also doubles the number of sites where the organization is conducting their platform clinical trial, growing from 20 to 40 locations in the United States.
A platform clinical trial uses the same protocol as a traditional clinical trial, with a group of volunteers receiving either a placebo or an experimental product; but with a platform clinical trial, volunteers could receive one of several products being studied. Quantum Leap Healthcare Collaborative is using the approach for screening, with data reviewed frequently to eliminate ineffective treatments quickly and to move promising treatments quickly into later-stage clinical trials.
Candidate therapeutics will be assessed by a panel of federal and academic experts to determine eligibility for inclusion in the trial. Promising results could position those potential treatments for late-stage clinical trials with private sector or inclusion in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) clinical trials led by the National Institutes of Health.
Candidates will be selected that target the body’s response to the virus, known as host-targeted treatments, for the sickest patients. Other criteria include: the candidate’s development stage; the safety and efficacy data available to-date; available supply of the drug; realistic expectation that emergency use authorization could be granted during the current pandemic; and manufacturing capability that could get promising treatments to patients quickly.
The single platform clinical trial approach is less costly and more efficient than traditional multiple clinical trials of a single drug candidate. The approach also allows researchers to compare the drug candidates head-to-head to identify which ones would be best for specific conditions or could be useful in combination. Such information would aid healthcare providers in making decisions about patient treatment.