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.
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“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.
About the Author Reprints
There is a an anti-viral coronavirus flu drug that is already approved and used in the US, Canada, EU, Japan, Korea, Taiwan, Australia. It is called Rapivab (from BioCryst Pharmaceuticals BCRX) and it interferes with the virus’s ability to replicate. Why is this not mentioned, or used ?? Or is this why in China and Korea the curve is flattening, and why Taiwan has very few cases ?
Dean W.,
What sort of infectious disease and antiviral therapy knowledge do you have? Any? If this drug is indeed so “promising” and “already approved”, why didn’t the WHO include it in their list of drugs to be tested expeditiously against coronavirus globally? Are you implying you know more than the WHO Director Tedros Adhanom Ghebreyesus and his experts at the WHO? Reeally? Kindly share your credentials!
Mr Chu : see for yourself : https://www.rapivab.com/.
One intravenous application, for any patient 2 years and older.
Also VERY easy to find on google. Reputable company, good drug, in may countries.
Rapivab is only made for use on uncomplicated influenza in patients who have been symptomatic for more than 2 days. ( https://www.rapivab.com/ )
Unfortunately it’s not a prophylactic agent but a reactive one. You wouldn’t administer it to someone asymptomatic, and generally by the time Covid-19 has incubated and symptoms have occurred, testing for it will take longer than two days.
Rapivab cannot/should not be administered before the confirmation of a viral infection, thereby rendering the antiviral largely ineffective in the treatment of Covid-19.
Correction: NO MORE than 2 days. Sorry, didn’t catch it before hitting Submit!
chloroquine is an anti-malarial drug, cheap and easily available, manufactured by hundreds of companies.
Gilead pharma is testing remdesivir, which is a covid-19 hopeful treatment candidate.
Who makes the chloroquine? IF we were to invest in a company ahead of the news who would we invest in?
WHO??!! The same org that declared 2 months ago the virus wasn’t transmissible from person to person…. because China told them so??!
Oh we are so screwed!!
When this is all over, the WHO should also be over! (:-/
Information trending on social media today the 18th day of march, 2020 say that chloroquine is a a sure cure to the COVID19 I want to know how true it is. Before I can share to friends and family members
Need to faster the trial with some pushing factor for the remaining Countries, Good be with us !!
It’s hesrtening to note thatW H O has started focusing on Covid-19 so fast.
I am sure Government of India will soon paryicipate and contrihute to this p
Project.
I can’t wait to read an article that a cure for coronavirus was invented. By the way, in the application utopia р2p in COVID-19 chat, I saw the latest news with expected forecasts in this regard.
Hi, I feel the best environment for COVID19 to spread is an environment of humidity over 60% with temperature below 26 Celsius. I feel successful treatment, control mechanisms should be considered based on this after analysis.. just a thought from my personal analysis.
Thanks for all your efforts! May God help us!
Roshan, fortunately feelings don’t count for much when it comes to medical treatments. Please be careful spreading misinformation as it often does more harm than good.
You’re of course right Roshan.
Dropping the relative humidity to as low as possible and raising the temperature as much above 20°C as possible will dramatically reduce the surface contamination time. Add plenty of air circulation and it drops even more. That’s a given. No virus likes being dry and warm.
How much it actually matters, is a good question. If surface contamination in public spaces is a main driver, then it matters a lot.
Reducing humidity, raising temperature and increasing airflow in office buildings/hospitals might be a rather good idea. Adding hysterical surface decontamination to the mix, would be obvious too. Spraying/coating often touched surfaces in public spaces with a mucous-solvent (common detergents) would also help in reducing contamination time.
It has been widely broadcast by Japan’s flagship TV station NHK that viagen has been efficacious for treating some patients. I would like to hear from Helen Braswell why did she not mention it or why the WHO did not consider including it in its lit of drugs? Another potential treatment proven to be effective in Wuhan, as widely reported by the CGTV (China Global Television Network) was using extracted plasma from recovered patients, which again was not mentioned nor picked up by the WHO. Makes we wonder whether Helen’s coverage is indeed sufficiently “broad”!?