Following a large study published in The Lancet, the WHO has decided to suspend hydroxychloroquine from the trials of which it is a partner. The European trial Discovery therefore finds itself on the sidelines once again.
- A very large study shows the ineffectiveness of hydroxychloroquine.
- The WHO therefore decided to exclude it from all the trials in which it was a partner.
- This decision will further complicate the rest of the European Discovery trial.
A lot of noise for nothing. After months of controversy over hydroxychloroquine, whose merits against the coronavirus are praised loud and clear by Professor Didier Raoult, the WHO decided on Monday May 15 to exclude it from all clinical trials in which it is a partner. The European Discovery test will therefore be concerned, reveals Franceinfo this Tuesday, May 16. Remember that hydroxychloroquine is a derivative of chloroquine, prescribed for years against malaria, better tolerated and prescribed in France under the name of Plaquénil, against lupus or rheumatoid arthritis. It is generally this second form that is tested in studies against Covid-19.
The WHO made this decision after the publication of a study in the medical journal The Lancet. The latter covers 96,000 patients and shows that neither chloroquine nor hydroxychloroquine are effective in the fight against Covid-19. On the contrary, the derivative would even increase the risk of death from cardiac arrhythmia. According to its lead author, Dr. Mandeep Mehra, it is the “first large-scale study” to show arobust statistical evidence” that these treatments “do not benefit Covid-19 patients”. For his part, Didier Raoult judges the study “bullshit“because realized”by people who have not seen patients”.
However, this trial is not the first to discredit hydroxychloroquine in the fight against Covid-19. Recently, two papers published in the BMJ attested to its ineffectiveness. The first study, French, concerns 181 adults admitted to hospital because of pneumonia due to the coronavirus, requiring that they be administered oxygen. In all, 84 of these patients received hydroxycholoroquine daily. Result: this treatment did not change anything, whether for transfers to intensive care or for patient mortality. “Hydroxychloroquine has received planetary attention as a potential treatment for Covid-19 after positive results from small studies. However, the results of this study do not support its use in patients admitted to hospital who require oxygen.”conclude the researchers.
Discovery was already well undermined
According to the second study, conducted by a Chinese team, hydroxychloroquine would not eliminate the virus faster than conventional treatments in patients suffering from a form “light” Where “moderate” of Covid-19. Moreover, more significant side effects have been observed in patients treated with this drug. “Taken together, these results do not support the use of hydroxychloroquine as a routine treatment for patients with Covid-19.therefore concludes in a press release the British medical journal BMJwhere both studies were published.
From now on, the decision taken by the WHO therefore risks changing the situation for many studies, in particular the European Discovery trial, which has already been badly damaged. Launched on March 22, this trial is testing five treatments against Covid-19, four of which are experimental. Among the treatments on the test bench, remdesivir, an antiviral developed without success during the Ebola epidemic, a combination of two antivirals (lopinavir/ritonavir) used against HIV, these two antivirals to which interferon is added beta, molecules of the immune system, and, finally, hydroxychloroquine.
“Identify side effects very quickly”
Originally, this study was to be carried out on 3,200 infected patients across Europe, but besides France, most of the countries involved did not play the game. Especially because of Solidarity, another study carried out by the out of 3000 patients. However, Florence Ader, principal investigator of the Discovery study, does not want to give up. She still hopes that Belgium, Austria and Germany will join the trial. “The time it took us to set up the trial in France was a time that was dedicated only to that, from March 1st to 22ndshe explained last week to European 1. Then we entered a second phase, we started to understand that we were going to need a little more time to set it up in a certain number of European countries.” “We still need a little bit of time and we will probably come back to an analysis at the beginning of June which will tell us if we can start releasing information”added Professor Bruno Lina, virologist at the Lyon University Hospital and member of the scientific council, at RTL, while the first results were expected for May 15.
This Tuesday, May 26, Bruno Lina spoke on RTL about the decision of the WHO. For the virologist, the vast study of The Lancet “identifies the fact that hydroxychloroquine has no effect in terms of virological results and it identifies a potentially deleterious effect of the implementation of the treatment. (…) In the Discovery trial, the decision was made, firstly to stop the inclusion of patients in the hydroxychloroquine arm and secondly to return to these patients. Because if there are side effects that have appeared, they must be identified very quickly and that we confirm or invalidate the message that has been passed on by the study”he said, ensuring that he had taken no risk in the trial.
As for Solidarity, the researchers wish to examine their own data and compare them with those of the study published in The Lancet. After having stopped administering hydroxychloroquine for a few days, the executive committee will decide whether or not to reinstate chloroquine and its derivative.