BIDMC helps lead launch of clinical trial evaluating well-known anti-viral drug as treatment for COVID-19

Boston – The Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window, or TREAT-NOW is a new study of an anti-viral medication for patients at home with COVID-19.  Adults with COVID-19 typically have an initial period of a flu-like illness that lasts for about a week, and then most patients recover. Unfortunately, some patients—physicians still cannot predict exactly who—will develop more severe breathing problems and require hospitalization; this typically occurs during the second week of the illness. 

Physician-scientists at Beth Israel Deaconess Medical Center (BIDMC) in collaboration with colleagues at Vanderbilt University Medical Center and University of Colorado are now enrolling patients in the TREAT-NOW clinical trial, testing whether a well-known anti-viral medication (lopinavir/ritonavir) can prevent the onset or mitigate the severe clinical symptoms of COVID-19 in non-hospitalized patients with laboratory confirmed COVID-19. Nathan Shapiro, MD, MPH, Professor of Emergency Medicine at BIDMC is one of the leaders of the TREAT NOW study, which includes sites from around the country.

“A unique feature of COVID-19 is the week or so delay between the onset of the first symptoms—such as fever and cough—and the progression to pneumonia and respiratory failure,” said Shapiro, who is Principal Investigator at BIDMC. “We’re looking to exploit this treatment window to prevent symptoms from worsening and to improve patient outcomes.” 

The study uses an innovative approach where patients are consented over the phone while at home, study medication is supplied by overnight mail, and then remotely monitored via phone calls and secure electronic text messages and electronic forms for a month after enrollment.

Designed to prevent viral replication in the early stages of infection, lopinavir/ritonavir has been prescribed to patients with HIV since 2000. Shapiro and colleagues are enrolling adult patients who are isolating at home within six days of testing positive for COVID-19. Those that are eligible for the study will be randomized to receive either lopinavir/ritonavir or placebo (an inactive pill that contains no medication). The study is being performed to determine whether the drug combination can lessen the severity of COVID-19 by suppressing viral replication in the days soon after symptoms develop.

“As an emergency physician, by the time I see patients with COVID-19, they are often presenting to the hospital in fairly desperate shape,” said Shapiro. “Intervening before the disease becomes severe could lessen the strain on hospitals and, more important, potentially save lives.”

For more information, visit ClinicalTrials.Gov.