Based on new research in preprint, use of HCQ in out-patients without high-risk factors carries no substantial dangers. As stated by News Medical on July 27, “Clinical trials of hydroxychloroquine in COVID-19 outpatients reported as safe.” The research found that the most common side-effect was gastroenteseral issues, and there were no deaths. While HCQ is shown to have in vitro effects against SARS-CoV-2, “correspondingly strong evidence of its activity in the treatment or prevention of this disease has not been found so far.” WHO and other studies are looking at safety and efficacy, “in both asymptomatic or mildly symptomatic cases, as well as sicker patients in hospitals.”
The FDA revoked the EUA for HCQ, “for the use…in severely ill COVID-19 patients,” after research found harmful or deadly cardiac side effects with HCQ combined with azithromycin. The most serious side effects were in patients who either used HCQ with “another arrhythmogenic drug,” used for extended periods, or using at excessive dosage. Historically, HCQ has a good record. And when used in appropriate populations, “it is a useful drug in multiple disciplines and has been used in autoimmune rheumatic conditions.” Such uses rarely involve ECG monitoring. New Medical posits that in some cases it is the virus and not the HCQ causing damage, and emphasizes the oversized doses being used.
The Virus, and not HCQ, May be Culprit in Arrhythmias
The COVID-19 virus, “may gain entry into cardiac cells and cause damage, and even arrhythmias, as reported in many cases.” Also, these heart conditions might be caused by elevated cytokines. Last, the virus can disrupt “normal electrolyte levels” which can cause arrhythmias if a patient has kidney failure. The instant study looks at the safety of HCQ in outpatients, and it compiled data from three RCT’s wherein the drug was used as prophylaxis and also as an early treatment. About 2,800 patients were considered with a median age of 40. About 60% were in good health. Of those who got post-exposure or post-infection treatment with HCQ, about 30% reported side effects. The most common problem reported was stomach upset or related issues. In a post-exposure placebo group, the rate of these side effects was comparable to the treatment group. Of the 2,800 patients, there were two instances of heart arrhythmias, and one of these was in a placebo group. No deaths were reported.
TrialSite News will continue to follow the HCQ story with a goal to provide accurate information free of political influence.