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WHO Beginning Covid-19 Therapy Trial

Tedros Adhanom Ghebreyesus

Tedros Adhanom Ghebreyesus, Director-General, World Health Organization (Elma Okic, UN)

19 Mar. 2020. World Health Organization is organizing an international clinical trial to test four treatments for the novel coronavirus, or Covid-19, pandemic. The Solidarity trial was announced yesterday by WHO director-general Tedros Adhanom Ghebreyesus at a briefing for the media in Geneva, Switzerland.

WHO revealed the trial as the number of Covid-19 cases worldwide exceeded 200,000. A global case tracking dashboard hosted by Johns Hopkins University says as of today (19 March), more than 222,000 cases are reported in 159 geographic regions, leading to more than 9,100 deaths. More than 9,400 of those cases are reported in the U.S., with 125 deaths linked to the disease.

Ghebreyesus said the trial aims to provide solid evidence of efficacy for various drugs that may be effective as a therapy for people already infected with the virus. “Multiple small trials with different methodologies,” says Ghebreyesus at the briefing, “may not give us the clear, strong evidence we need about which treatments help to save lives.”

The organization says so far 10 countries offered to take part in the trial: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand. Other countries are expected to join the study. Ghebreyesus says the trial will use, “simplified procedures to enable even hospitals that have been overloaded to participate.”

The health newsletter STAT reports WHO’s Ana Maria Henao-Restrepo, who heads the organization’s research and development group, outlined the major questions to be answered by the trial: “Do any of these drugs reduce mortality? Do any of these drugs reduce the time a patient is in hospital and whether or not the patients receiving any of the drugs needed ventilation or intensive care units?”

STAT says the trial is testing four different potential treatments for Covid-19

– The anti-viral drug remdesivir, made by Gilead Sciences

– Combination of HIV protease inhibitors lopinavir and ritonavir, made by AbbVie

– Combination of lopinavir and ritonavir plus interferon beta, an anti-inflammatory drug for treating multiple sclerosis

– Anti-malarial drug chloroquine

Remdesivir is already being assessed as a Covid-19 treatment in a trial sponsored by National Institutes of Health. The other drugs have shown efficacy in lab cultures or tests with lab animals.

Henao-Restrepo tells Stat the Solidarity study will use an adaptive design similar to an international trial to test four Ebola drugs in 2018. She says the trial design makes it possible to make modifications as results begin coming in, noting “the randomization could be adjusted to the drugs available in each individual hospital over time,” and “we can include additional arms or drop arms as our global data safety and monitoring committee advises we should do.”

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