Medicines based on chloroquine and hydroxychloroquine, in Marseille. - GERARD JULIEN / AFP
- A large study on 1,300 patients with coronavirus must be launched to assess the effectiveness of hydroxychloroquine, announces the University Hospital of Angers.
- Half of the patients will receive a placebo, the other half of hydroxychloroquine, for the first results expected in "a few weeks".
Objective: “to close the debate” on the efficacy of a chloroquine derivative. The Angers University Hospital announced Tuesday the launch of a large study on 1,300 patients with Covid-19. "It meets the highest scientific and methodological standards," said Professor Vincent Dubée, principal investigator of the project, during a press briefing. It will be carried out under conditions which will leave no room for doubt in the analysis of the results. ”
Professor Didier Raoult has published in recent weeks two studies on a chloroquine derivative, which he says confirm the "effectiveness" of this treatment against the coronavirus. But this assertion is disputed by many scientists, who notably criticize the methodology used. The Angevin study, dubbed Hycovid and conducted with 32 other hospitals in France, "will provide a definitive answer to these questions and close once and for all the debate on the efficacy of hydroxychloroquine in Covid", said assured Professor Dubée.
Placebo and chloroquine
"We have a neutral position vis-à-vis this molecule. We obviously all have great hope that this molecule will be active in the Covid. However, we are aware of the limits of the results of the studies published by Professor Raoult's team, ”he added. “We don't have a priori, we didn't participate in the media fuss around this molecule. "
The Hycovid study, to start on Wednesday, will be double-blind: neither patients nor doctors will know whether the patient is receiving chloroquine or a placebo. Half of the patients will receive a placebo, the other half of chloroquine. These will be patients over the age of 75 or patients who need oxygen without being "in acute respiratory distress". Patients can be hospitalized, residents of a nursing home or simply at home.
“One of the strengths of this study is that it will include patients with a non-serious form of the disease but at high risk for an unfavorable course, such as certain elderly people. We will therefore treat people early, which is probably a determining factor in the success of treatment, "said Professor Dubée. The first results should be known in "a few weeks", he promised.
How to judge its effectiveness?
"If the effect is very large, the response is likely to be very rapid. Very quickly, there will be so many lives saved or patients not intubated (…) that we will be able to see it and stop (the study). If the effect is less significant, it will take a little more time ”, described Professor Alain Mercat, president of the medical commission of establishment of the CHU of Angers.
To judge the effectiveness of the molecule, "we would like the percentage of transition to resuscitation or death to be reduced to 14%" in patients who have received hydroxychloroquine, against 20% currently for untreated patients, a clarified Professor Dubée. The costs of the study, of 850,000 euros, are advanced by the University Hospital of Angers, which has applied for public funding. Donors "are welcome" to "help us finance the project," said the hospital, however.
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