Updated June 22, 2020:
Both of the clinical trials detailed below were officially halted on Friday, June 19, 2020. The National Institute of Allergy and Infectious Diseases (NIAID) and Novartis cited difficulty enrolling patients as the reason for abandoning the trials. Both sponsors believed the slow enrollment was due to multiple other studies showing that hydroxychloroquine was not effective at treating or preventing COVID-19. Both sponsors also stressed that the studies were not closed due to safety concerns.
Each of the trials, which had planned to enroll 440 hospitalized (Novartis) and 2,000 non-hospitalized (NIAID) COVID-19 patients, only managed to enroll a handful of participants across the nation in the few months they were open. The University of Rochester Medical Center did not enroll any patients in the two weeks it was running the studies.
While hydroxychloroquine will no longer be offered at URMC, several other experimental treatments are currently available or will become available soon. URMC is currently running more than 50 COVID-19-related clinical studies, ranging from testing experimental drugs or vaccines to understanding immunity or social impacts of the disease.
URMC researchers are joining a pair of new national clinical trials this week that will test whether hydroxychloroquine (HCQ), an FDA-approved anti-malarial drug, can keep COVID-19 patients alive and out of the hospital. While HCQ has been widely touted as a potential treatment for COVID-19, results from coronavirus research studies reported thus far have been contradictory and inconclusive.
These new randomized, controlled trials, which are sponsored separately by the National Institute of Allergy and Infectious Diseases and the Novartis pharmaceutical company, are designed to provide clear and conclusive evidence that can guide future treatment of COVID-19 patients. Through the studies, some COVID-19 patients will be treated with HCQ with or without the powerful antibiotic azithromycin, which is often used to treat respiratory infections, while others will receive placebo.
“We really don’t yet know if HCQ can help people recover from COVID-19 disease,” said Michael Keefer, M.D., professor and interim chief of Infectious Diseases at the University of Rochester Medical Center and local leader of the studies, “so it’s really important that we study it in a carefully controlled way. Of course, we all hope that it is an effective treatment, but we won’t be able to show that until we do this kind of study.”
According to Keefer, the fact that HCQ can be taken as a pill makes it particularly attractive for treating non-hospitalized patients. Remdesivir, the only drug cleared to treat COVID-19, is given by intravenous infusion, making it a great choice for hospitalized patients, but less convenient for outpatients.
Across the two trials, Keefer and his team aim to enroll 20 hospitalized COVID-19 patients and up to 200 people with new COVID-19 diagnoses, who don’t require hospitalization. The inpatient study will treat patients for 10 days and the outpatient study will treat patients for 7 days, both groups will have their health tracked beyond the time of recovery. To whatever extent possible, the outpatient treatment study will be conducted remotely to protect both patients and healthcare providers.
Keefer’s team will monitor patients for signs of side effects and to determine whether the treatment can reduce viral shedding as well as symptom severity or duration.
URMC is one of approximately 25 sites in the AIDS Clinical Trials Group that are conducting the outpatient trial and one of 20 sites conducting the inpatient trial across the U.S. Keefer and his team will enroll hospitalized patients at Strong Memorial Hospital and outpatients with mild COVID-19 disease from the greater Rochester region.