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Hydroxychloroquine, sold under the brand name Plaquenil among others, is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine. Other uses include treatment of rheumatoid arthritis, lupus, and porphyria cutanea tarda. It is taken by mouth, often in the form of hydroxychloroquine sulfate. [3]
The paper, published in 2020 in the International Journal of Antimicrobial Agents, originally claimed that treatments with hydroxychloroquine, an anti-malaria drug, reduced virus levels in COVID ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
A French study published in 2024 found that the use of hydroxychloroquine may have been associated with 17,000 deaths in Belgium, Turkey, France, Italy, Spain, and the United States. [61] [62] This study was ultimately retracted on August 22, 2024, after "the Editor-in-Chief found the conclusions of the article to be unreliable".
The medical journal The Lancet on Thursday retracted a large study on the use of hydroxychloroquine to treat COVID-19 because of potential flaws in the research data. Thursday's retraction doesn't ...
Chloroquine and hydroxychloroquine are anti-malarial medications also used against some auto-immune diseases. [65] Chloroquine, along with hydroxychloroquine, was an early experimental treatment for COVID-19. [66] Neither drug has been useful to prevent or treat SARS-CoV-2 infection.
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
[2] [16] Following a study published by The Lancet on safety concerns with hydroxychloroquine, the WHO suspended use of it from the Solidarity trial in May 2020, [197] [198] reinstated it after the research was retracted, [199] then abandoned further use of the drug for COVID-19 treatment when analysis showed in June that it provided no benefit ...
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