The World Health Organization (WHO) suspended the hydroxychloroquine trial amid the coronavirus pandemic. The decision comes after the study findings published in The Lancet reported issues on the drug's efficacy and safety. Now, the journal has issued a correction on the figures reported in the study.
The coronavirus disease (COVID-19) has ravaged across the globe, infecting more than 6.26 million people across the globe and killing more than 375,000 people. Hydroxychloroquine is one of the drugs seen as a potential treatment for the novel coronavirus.
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What is hydroxychloroquine?
Hydroxychloroquine, sold under the name Plaquenil, and its sister drug chloroquine, sold under Aralen, are under investigation for the treatment of COVID-19, caused by the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The drug is classified as an anti-malarial and used in treating several forms of malaria. Today, it is used to treat rheumatoid arthritis, some symptoms of lupus, childhood arthritis (or juvenile idiopathic arthritis), and other autoimmune diseases.
The drug works by altering the human immune system, since it is an immunomodulator, but has a range of severe side effects, including altered heart rhythm and eye damage.
The Solidarity Trial aimed to evaluate the efficacy and safety of four drugs and drug combinations to combat COVID-19. In the trial, there are more than 400 hospitals in 35 countries that are actively recruiting patients. At least 3,500 patients have been enrolled in 17 countries.
On May 25, the WHO had announced it suspended the trial of hydroxychloroquine in treating COVID-19 patients due to the drug's potential danger to patients. Many countries have halted the trials as a precaution.
WHO made the decision after the study suggested that the drug could heighten the risk of patients dying from COVID-19. Further, patients were seen to experience heart problems.
The Lancet issued the study corrections four days after the WHO suspended human trials of the drugs.
On May 29, the journal issued a clarification that the study reported the wrong number of participants in Australia and Asia. However, the study results remain unchanged.
One hospital self-designated to belong to the Australasia continental designation should have been assigned to the Asian continental designation.
"In this Article, in the first paragraph of the Results section, the numbers of participants from Asia and Australia should have been 8101 (8·4%) and 63 (0·1%), respectively. One hospital self-designated as belonging to the Australasia continental designation should have been assigned to the Asian continental designation," The Lancet corrected.
"The appendix has also been corrected. An incorrect appendix table S3 was included, originally derived from a propensity score-matched and weighted table developed during preliminary analysis. The unadjusted raw summary data are now included. There have been no changes to the findings of the paper. These corrections have been made to the online version as of May 29, 2020, and will be made to the printed version," it added.
Scientists challenging study data and findings
In an open letter to the authors of the study and the editor of The Lancet, more than 200 scientists report that the data from Australia are not compatible with government reports.
They are challenging the validity of the influential study that found a link between hydroxychloroquine and chloroquine for COVID-19 patients and an increased in-hospital death. The study also found that the drugs have increased the risk of abnormal heart rhythm.
The scientists highlighted concerns about the quality of the data and its analysis. One of the issues pointed out was the lack of information about the countries and hospitals that contributed data, which was provided by Chicago-based healthcare data analytics firm, Surgisphere.
Further, other issues underscored included discrepancies in the data Australia, where there were more deaths recorded in the hospitals covered by the study than the official figures from the government.
"There are now 201 signatories from all over the world. My email inbox has been flooded, so I apologize if I've missed some people," James Watson posted.