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WHO to launch multinational trial to jumpstart search for coronavirus drugs

Wednesday, March 18, 2020   (0 Comments)
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WHO to launch multinational trial to jumpstart search for coronavirus drugs




By Helen Branswell @HelenBranswell

March 18, 2020    

Source: https://www.statnews.com/2020/03/18/who-to-launch-multinational-trial-to-jumpstart-search-for-coronavirus-drugs/

The World Health Organization said Wednesday that it would launch a multiarm, multicountry clinical trial for potential coronavirus therapies, part of an aggressive effort to jumpstart the global search for drugs to treat Covid-19.

Four drugs or drug combinations already licensed and used for other illnesses will be tested, said WHO Director-General Tedros Adhanom Ghebreyesus. Ten countries have already indicated they will take part in the trial.

The mere fact the WHO is sponsoring the trial suggests that efforts in China to test these drugs may not have come up with enough data to indicate whether any were of use to prevent patients from developing severe disease or save those with severe disease from death.

The study, which Tedros said he hopes other countries will join, has been named the SOLIDARITY trial. Countries that have already signed on are: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand.

“Multiple small trials with different methodologies may not give us the clear strong evidence we need about which treatments help to save lives,” he said during a briefing in Geneva.

Ana Maria Henao-Restrepo, unit head for the WHO’s research and development “blueprint” group, said the trial design was deliberately kept simple “to enable even hospitals that have been overloaded to participate.”

“This trial focuses on the key priority questions for the public. 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,” Henao-Restrepo said.

The four drugs or combinations will be compared to what is called standard of care — the regular support hospitals treating these patients use now, such as supplementary oxygen when needed.

The drugs to be tested are the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and the antimalarial drug chloroquine. All show some evidence of effectiveness against the SARS-CoV 2 virus, which causes Covid-19, either in vitro and/or animal studies.

Remdesivir is made by Gilead. Lopinavir and ritonavir are combined and sold as Kaletra or Aluvia by AbbVie.

Later in the day, after close of business in Geneva, the New England Journal of Medicine published a study from China that reported finding that the lopinavir-ritonavir combination did not improve survival or speed recovery, though the authors noted that the very high death rates among patients who received the drugs and those who received only standard care suggest they had enrolled “a severely ill population.”

Of the 199 patients in the trial, 22% died, which was “substantially higher than the 11% to 14.5% mortality reported in initial descriptive studies of hospitalized patients with Covid-19,” they said. The trial was also not blinded — meaning the doctors knew which patients were receiving the drugs — which they acknowledge could have influenced their clinical decision making.

“These early data should inform future studies to assess this and other medication in the treatment of infection with SARS-CoV-2,” wrote the authors. “Whether combining lopinavir–ritonavir with other antiviral agents, as has been done in SARS and is being studied in MERS-CoV, might enhance antiviral effects and improve clinical outcomes remains to be determined.”

Henao-Restrepo said chloroquine — which is cheap and used regularly around the world — will be tested two ways. Some countries will test chloroquine against the standard of care while others will test hydroxychloroquine, a related drug.

“The good thing about the trial is … that the randomization could be adjusted to the drugs available in each individual hospital over time,” Henao-Restrepo said. “The other good thing … is that we can include additional arms or drop arms as our global data safety and monitoring committee advises we should do.”

Enrolling patients across a number of countries should speed the world to an answer about which drugs, if any could be effective in reducing the toll of Covid-19. The WHO launched a similar trial in the Democratic Republic of the Congo in November 2018 to test four therapies against Ebola.

At the time of that launch, it was thought that the trial might need to draw data from several Ebola outbreaks before it could reach an answer. But the North Kivu outbreak, which could be declared over next month, was so large results were announced in August 2019. Given the high number of cases globally of Covid-19 and the number of countries participating, results should come faster with this trial.

This story had been corrected to remove an error about where hydroxychloroquine can be used. It has also been updated.

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