The United States’ National Institutes of Health (NIH) has commenced clinical trials for the effectiveness of hydroxychloroquine for treating coronavirus. President Donald Trump and SpaceX’s Elon Musk among other notable personalities have endorsed the anti-malaria drug as a “game-changer” for treating COVID-19.
A scientific journal had also initially touted the chloroquine derivative as effective for the cure of coronavirus.
The National Heart, Lung, and Blood Institute (NHLBI) which is part of the NIH said the participants for the clinical trial have been enrolled at the Vanderbilt University Medical Center in Nashville. The researchers said more than 500 adults who are currently hospitalized for COVID-19 or in emergency wards as a result of the infection will be enrolled for the trial across the U.S.
“All participants in the study will continue to receive clinical care, as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine,” the researchers wrote.
Lead researcher for the study, Dr. Wesley Self of Vanderbilt University Medical Center, stated that many hospitals across the US use hydroxychloroquine as the first-line therapy for patients hospitalized for coronavirus even though there is a scarcity of scientific evidence that it is effective against the disease. To this end, scientific data is urgently needed to inform clinical practice for applying hydroxychloroquine to treating COVID-19.
“Preliminary reports suggest potential efficacy in small studies with patients,” said NHLBI Division of Lung Diseases director James P. Kiley. “However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”
Meanwhile, the publisher of the International Journal of Antimicrobial Agents has denounced a recent publication in the journal that hydroxychloroquine is effective against coronavirus following a study carried out on 20 patients in France. The endorsement was published in the March 20 edition of the journal.
However, the International Society of Antimicrobial Chemotherapy (ISAC), publisher of the journal, had on April 3 stated that the editorial endorsement of hydroxychloroquine for treating coronavirus “does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.”
ISAC noted that even though the journal aims to publish new data fast to help members of the scientific community make informed decisions, “This cannot be at the cost of reducing scientific scrutiny and best practices.” The publisher faults the inclusion process for the participants used for the study which took place at the Méditerrannée Infection University Hospital Institute in Marseille, France.
The FDA approved the use of hydroxychloroquine for the treatment of lupus and rheumatoid arthritis since the anti-malaria drug contains anti-inflammatory properties. The agency on March 28 also authorized the emergency use of the drug, including chloroquine phosphate, for the treatment of COVID-19 patients. Doctors around the country also agree that the drug might be effective against coronavirus but called for more scientific research and clinical trials to be certain.