As the coronavirus disease (COVID-19) continues to ravage across the globe, scientists are racing to develop an effective treatment or vaccine to combat the deadly disease.
Over the past few months, doctors resorted to repurposing medicines that have already been approved for other diseases to treat coronavirus patients. One drug that was widely used in the pandemic, hydroxychloroquine, has been found to be ineffective in treating the viral infection.
Based on an extensive study of nearly 1,400 patients with moderate to severe coronavirus disease at a New York hospital, the researchers at the Columbia University Medical Center found that patients who received the drug fared no better than those who did not.
This is the largest published study on the use of hydroxychloroquine in COVID-19 patients. Previous studies have only included no more than 100 patients.
No effect on the risk of death
Hydroxychloroquine is a drug used to prevent and treat malaria. It has also been used to treat other diseases such as systemic lupus erythematosus and rheumatoid arthritis, which are autoimmune conditions. In the advent of the coronavirus pandemic, the drug has been used for patients to lower the rate of dying from the illness.
In the study published in the prestigious New England Journal of Medicine, the team of researchers looked at data on patients treated for COVID-19 in New York City, the epicenter of the outbreak in the United States. Some patients received hydroxychloroquine of an ‘off-label’ basis, a practice allowing doctors to prescribe a drug for an unapproved indication or in an unapproved age group, dosage, or route of administration.
An estimated 60 percent of the patients received the drug for about five days. The team found that hydroxychloroquine has no impact on the risk of the most severe outcomes from the disease. There is no lower rate of needing ventilators or a reduced risk of death during the study period.
“In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite endpoint of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with COVID-19 are needed,” the authors wrote in the paper.
The study findings
The team wanted to see the link between hydroxychloroquine use and the development of respiratory failure that led to intubation or death.
To arrive at their findings, the researchers included the first 1,376 patients admitted in the hospital for COVID-19, which is caused by the pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). They excluded patients who had recovered, intubated, or died within 24 hours of being treated in the emergency department.
Of these patients, 811 patients or nearly 60 percent received the drug while 565 or 41 percent did not.
The team also found that the patients who received the drug were more severely ill at baseline than those who did not. Overall, 346 patients had a primary endpoint event wherein 180 patients were intubated ( al procedure involving the insertion of a tube into the body). Of these patients, 66 succumbed to the disease. Another 166 patients died without intubation.
“In the crude, unadjusted analysis, patients who had received hydroxychloroquine were more likely to have had a primary endpoint event than were patients who did not,” the team explained.
The team emphasized that the findings of the study show that the drug has no benefit for COVID-19 patients.
“We don’t think at this point, given the totality of the evidence, that it is reasonable to routinely give this drug to patients. We don’t see the rationale for doing that.” While the study did not randomly assign people to receive the drug or placebo and compare their outcomes, the large number of patients involved suggests the findings are solid,” Dr. Neil Schluger, chief of the division of pulmonary, allergy and critical care medicine at Columbia, said in a statement.
Side effects
In March, the drug received a positive response when it led to a reduced viral load, but only in a small and uncontrolled number of COVID-19 patients. Further, other studies have revealed that the drug may have side effects, including a prolonged QT interval in the heart, causing an irregular heartbeat. Dysrhythmia or an irregular heartbeat may increase the risk of sudden cardiac arrest, which is fatal.
The side effects accompanying the use of the drug promoted the U.S. Food and Drug Administration (FDA) to issue a warning in April.
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Journal reference:
Link between COVID-19 and long-term risk of autoimmune and autoinflammatory connective tissue disorders