Two German studies analyzing the effects of hydroxychloroquine on Covid-19 patients could soon resume after being suspended for two weeks. This break follows the publication of a paper in The Lancet ensuring that not only is hydroxychloroquine ineffective against the coronavirus, but that it could also be dangerous for certain patients.
- In Germany, the University of Tübingen had initiated two double-blind studies to test the effectiveness of hydroxychloroquine on coronavirus patients.
- However, this research was interrupted following a publication in “The Lancet” denouncing the harmful effects of this treatment.
- Since the study has since been withdrawn by its authors, German research may resume soon.
We have not finished hearing about hydroxychloroquine, a derivative of chloroquine (antimalarial), used in the treatment of autoimmune diseases. While the Eberhard Karl University of Tübingen (Germany), had to suspend two studies on the effects of this drug against the coronavirus because of the controversial study published at the end of May in The Lancet, the latter could soon resume and enlighten us a little more on the question.
The University of Tübingen launched its first study on hydroxychloroquine on March 29. This involved 220 hospitalized patients with acute symptoms of Covid19. Half of the patients received a “normal dose” of hydroxychloroquine sulphate, i.e. a first dose of 800 mg, then 600 mg on the second to seventh day, as prescribed in case of autoimmune disease or during the first days of malaria. The other half of the patients received a placebo.
The second study was launched on April 22. Here, the researchers followed 2,700 patients with only mild symptoms of Covid-19 and not requiring hospitalization. Again, half of the outpatients received a daily dose of 600 mg of hydroxychloroquine sulfate for 7 days.
The first results must be examined by an independent commission
But on April 29, the Federal Institute for Drugs and Medical Devices (BfArM), the medical regulatory authority, issued a first warning about hydroxychloroquine. Then, on May 22, the study published in Tea Lancet is changing the game around the world. After analyzing data collected by the American company Surgispheren and concerning 96,000 patients hospitalized between December and April in 671 hospitals around the world, the researchers found no benefit from the use of chloroquine-based treatments on patients with of Covid-19. Worse, this treatment would be dangerous because of its side effects, particularly cardiovascular.
Following this publication, the WHO decided to suspend any clinical trial using chloroquine or its derivative. In Germany, the BfArM renews its warnings. After which, the Federal Minister of Health and the University of Tübingen decide to put the two studies on hold for two weeks, reveals the local newspaper The Spiegel May 28. “I am convinced that we can continue the process”, However, assures the director of the Institute, Professor Peter Kremsner, to the German daily. According to him, hydroxychloroquine can, in certain cases, be used in patients in whom the risk of side effects is particularly high.
The first results obtained by the University of Tübingen must now be examined by an independent commission. The latter will then decide, in collaboration with the BfArM and the competent ethics committee, on a possible resumption of research.
The study published in The Lancet was finally withdrawn
Although it led to the suspension of many studies around the world, the article published in The Lancet is now very controversial and several trials including chloroquine-based treatments have since resumed. The day after publication, 120 scientists put their signatures in a open letter to express their concerns about the methods used during the study. “This review raised both methodological and data integrity concerns.”, advance in particular the scientists.
The comparison of data from several hospitals with different protocols or even the origin of the data questions the specialists. Do they “can name the Canadian hospitals they claim have contributed data, so it can be independently verified?”, wonders for example Todd Lee, expert in infectious diseases at the Canadian university McGill, on Twitter.
The controversy escalated to such an extent that The Lancet hastens to publish a press release acknowledging “significant doubts” about the famous study. A few days later, three of the four authors of the paper decided to withdraw it from the prestigious British scientific journal. On June 3, the WHO announced that it would resume trials using chloroquine. In France, the French Medicines Agency (ANSM) declares that it will review its position after having suspended sixteen clinical trials in progress on the territory.
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