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With Africa’s COVID-19 caseload rising and national health systems feeling the pressure, more than a dozen nations have signed on with a large drug trial searching for a way to treat mild to moderate COVID-19 cases with inexpensive, readily available drugs before patients require a trip to the hospital.
“There is a need for large clinical trials in Africa for COVID-19 to answer research questions that are specific to an African context,” Dr. John Nkengasong, director of the Africa Centres for Disease Control and Prevention, said as he launched the trial in November in the Democratic Republic of the Congo. The DRC was the first country to enroll patients in the study.
The clinical trial involves 13 countries from Mali to Mozambique. It is being conducted by ANTICOV, a consortium of public health organizations with the goal of finding existing drugs that can stop COVID-19 early, before the patient adds to the burden on national health care systems.
“This is the first major drug trial across the continent,” epidemiologist John Amuasi, who leads Ghana’s ANTICOV contingent, told Science magazine. “I would have liked this to come much earlier, but it’s really great that this is happening.”
Since COVID-19 arrived on the continent earlier this year, the Africa CDC has reported more than 2.2 million cases, 1.8 million recoveries and 52,000 deaths.
Of more than 1,100 COVID-19 drug trials around the world, only 50 are taking place in Africa.
ANTICOV aims to recruit up to 3,000 patients for its trials. Under the guidelines, people who come to participating hospitals for any reason will be tested for COVID-19. If they test positive, they’ll be invited to join the study.
Those who join will receive either a study drug or a painkiller for three weeks. They’ll report their symptoms every day by phone or by smartphone app. If their blood oxygen level drops below 94%, researchers will view that as a negative result for the drug they’re taking.
The nonprofit Drugs for Neglected Diseases initiative is part of the consortium that has developed the trial. DNDi officials said in a statement that the trial will target COVID-19 with drugs used to treat malaria, HIV, hepatitis C, parasitic infections and certain cancers. The list includes the antiretroviral cocktail lopinavir/ritonavir used to treat HIV and hydroxychloroquine used to treat malaria.
As an adaptive platform trial, the protocol lets researchers try many different drugs at the same time. This lets them quickly drop ones that prove ineffective and add new ones to the list for testing.
Hydroxychloroquine is included in the study. It was determined to be ineffective in clinical trials on hospitalized patients with severe symptoms in the U.S., but its effectiveness in treating mild cases has not been studied. It remains the standard of care for mild cases in 16 African countries.
The ANTICOV trial is getting underway as global pharmaceutical companies have begun releasing COVID-19 vaccines. At least two of those vaccines — by Pfizer and Moderna — must be transported and stored at temperatures between 20 and 80 degrees below zero Celsius, a challenging requirement for most African hospitals and health care systems.
The third announced vaccine, this one by Oxford University and AstraZeneca, can be stored at normal refrigeration temperature. The Kenya Medical Research Institute, which is part of ANTICOV, also is enrolling subjects in a trial of the AstraZeneca vaccine.
“It is heartening to see so many African countries collaborate to get much-needed answers about our unique COVID-19 patient needs,” said Dr. Borna Nyaoke-Anoke, DNDi senior clinical project manager. “We need research here in Africa that will inform policies and test-and-treat strategies, so that as clinicians we can give the best options to people with COVID-19.”