COVID-19 treatments accelerates

Race to find COVID-19 treatments accelerates
In Section: IN DEPTH
WHO launches megatrial to test repurposed drugs and experimental drug candidates
By Kai Kupferschmidt and Jon Cohen

INFECTIOUS DISEASES

With cases of the new coronavirus disease 2019 (COVID-19) climbing steeply everywhere from Madrid to Manhattan , overwhelming one hospital after another and pushing the global death toll past 17,000, the sprint to find treatments has dramatically accelerated. Drugs that stop the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could save the lives of severely ill patients, protect health care workers and others at high risk of infection, and reduce the time patients spend in hospital beds.

The World Health Organization (WHO) last week announced a major study to compare treatment strategies in a streamlined clinical trial design that doctors around the world can join. Other trials are also underway; all told, at least 12 potential COVID-19 treatments are being tested, including drugs already in use for HIV and malaria, experimental compounds that work against an array of viruses in animal experiments, and antibody-rich plasma from people who have recovered from COVID-19. More than one strategy may prove its worth, and effective treatments may work at different stages of infection, says Thomas Gallagher, a coronavirus researcher at Loyola University Chicago’s Health Sciences Campus. “The big challenge may be at the clinical end determining when to use the drugs.”

Researchers want to avoid repeating the mistakes of the 2014–16 West African Ebola epidemic, in which willy-nilly experiments proliferated but randomized clinical trials were set up so late that many ended up not recruiting enough patients. “The lesson is you start trials now,” says Arthur Caplan, a bioethicist at New York University’s Langone Medical Center. “Make it a part of what you’re doing so that you can move rapidly to have the most efficacious interventions come to the front.”

To that end, WHO on 20 March announced the launch of SOLIDARITY, an unprecedented, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has emphasized simplicity so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate. WHO’s website will randomize patients to local standard care or one of the four drug regimens, using only ones available at the patient’s hospital. Physicians will simply record the day the patient left the hospital or died, the duration of the hospital stay, and whether the patient required oxygen or ventilation. “That’s all,” says Ana Maria Henao Restrepo, a medical officer at WHO’s Department of Immunization Vaccines and Biologicals.

The design is not blinded: Patients will know they received a drug candidate, and that could cause a placebo effect, Henao Restrepo concedes. But it is in the interest of speed, she says. “We are doing this in record time.” The agency hopes to start to enroll patients this week.

Rather than taking years to develop and test compounds from scratch, WHO and others want to repurpose drugs that are already approved for other diseases and have acceptable safety profiles. They’re also looking at experimental drugs that have performed well in animal studies against the other two deadly coronaviruses, which cause SARS and Middle East respiratory syndrome (MERS). And they are focusing on compounds plentiful enough to treat a substantial number of patients.

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