WHO launching master protocol for COVID-19 therapies

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WHO has launched an international master protocol to study the safety and effectiveness of drugs for treating patients hospitalized with COVID-19.

The trial is being conducted because “multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives,” WHO Director General Tedros Adhanom Ghebreyesus said at a press conference Wednesday.

The SOLIDARITY trial “provides simplified procedures to enable even hospitals that have been overloaded to participate,” Tedros said.

So far 10 countries have confirmed that they will participate in the trial: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand. WHO expects additional countries to join the trial, Tedros said.

The control arm for SOLIDARITY is the standard of care in the hospital where patients are being treated. Individual hospitals can enroll patients on any or all of the active treatment arms.

The trial will start with four treatment arms; treatments can be added or dropped in the future.

The initial treatment arms are remdesivir from Gilead Sciences Inc. (NASDAQ:GILD); the combination of two HIV treatments, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and chloroquine.

Endpoints for the trial will include reduction in mortality, reduction in the time patients are hospitalized, and need for ventilation or treatment in an intensive care unit, WHO said.

Lopinavir plus ritonavir already doesn't look promising in cases of severe COVID-19. An article published Wednesday in The New England Journal of Medicine showed that the combination twice daily for 14 days plus standard-of-care treatment vs. SOC alone failed to statistically significantly reduce the 28-day mortality rate (19% vs. 25%) or time to clinical improvement (HR=1.24, 95% CI: 0.90, 1.72) in patients hospitalized with severe COVID-19. Moreover, the antivirals lowered neither viral loads in throat swabs nor the percentage of patients with detectable SARS-CoV-2 RNA on days 5, 10, 14, 21 and 28.

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