Breaking News! COVID-19 Drugs: Another Chloroquine Clinical Trial Stopped Over Risk of Fatal Heart Complications As 11 Patients Die
Source: COVID-19 Drugs Apr 13, 2020 4 years, 8 months, 1 week, 2 days, 21 hours, 32 minutes ago
COVID-19 Drugs: This time a clinical trial of COVID-19 patients in Brazil ended early after patients taking a higher dose of chloroquine developed irregular heart rates. The clinical study was halted early for safety reasons after patients developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.
The drug chloroquine is closely related to the more widely used drug hydroxychloroquine. Both have been promoted as a potential treatment for the novel SARS-CoV-2 coronavirus despite little evidence that they work, and despite concerns from some of top health officials in the US and abroad. Last month, the US FDA granted emergency approval to allow hospitals to use chloroquine and hydroxychloroquine from the national stockpile if clinical trials were not feasible. Companies that manufacture both drugs are ramping up production.
The new Brazilian study involved 81 hospitalized patients in the city of Manaus and was sponsored by the Brazilian state of Amazonas. Because Brazil’s national guidelines recommend the use of chloroquine in COVID-19 patients, the medical researchers said including a placebo in their trial considered the best way to evaluate a drug was “not possible.”
https://www.medrxiv.org/content/10.1101/2020.04.07.20056424v1
Even with the study’s limitations, infectious disease doctors and drug safety experts said the study provided further evidence that chloroquine and hydroxychloroquine, which are both used to treat malaria, can pose significant harm to some patients, specifically the risk of a fatal heart arrhythmia. Patients in the trial were also given the antibiotic azithromycin, which carries the same heart risk. Hospitals in the United States are also using azithromycin to treat coronavirus patients, often in combination with hydroxychloroquine.
Dr David Juurlink, an internist and the head of the division of clinical pharmacology at the University of Toronto commented, “To me, this study conveys one useful piece of information, which is that chloroquine causes a dose-dependent increase in an abnormality in the ECG that could predispose people to sudden cardiac death.”
Almost half the study participants were given a dose of 450 milligrams of chloroquine twice daily for five days, while the rest were prescribed a higher dose of 600 milligrams for 10 days. Within three days, researchers started noticing heart arrhythmias in patients taking the higher dose. By the sixth day of treatment, 11 patients had died, leading to an immediate end to the high-dose segment of the trial.
The medical researchers said the study did not have enough patients in the lower-dose portion of the trial to conclude if chloroquine was effective in patients with severe disease. More studies evaluating the drug earlier in the course of the disease are urgently needed.
Several clinical trials for chloroquine and hydroxychloroquine are testing low doses for shorter periods of time in coronavirus patients. Even then a few have stopped due to the occurrence of abnormal heart beats.
It has already been reported that certain drugs used to treat COVID-19 can actually result in the deaths of patien
ts.
https://www.thailandmedical.news/news/covid-19-clinical-care-guidelines-to-prevent-drug-induced-prolongation-of-qtc-that-often-results-in-sudden-cardiac-death-in-covid-19-patients
However the Health Commission of Guangdong Province in China had initially recommended those sick with the virus be treated with 500 milligrams of chloroquine twice daily for 10 days.
Dr Marcus Lacerda, one of the authors of the Brazilian study commented that his study found that “the high dosage that the Chinese were using is very toxic and kills more patients.”
He added, “That is the reason this arm of the study was halted early.”
The manuscript of the study findings are being reviewed by the journal Lancet Global Health.
Thailand Medical News would like to highlight that in the beginning of the breakout and even now, the Chinese authorities (not Chinese doctors or researchers) had been spreading lots of misinformation deliberately and even a lot of the early studies done by Chinese medical experts were found to have been later ‘manipulated’ by Chinese authorities. In the last 6 weeks a lot of published Chinese studies in Chinese medical journals have been removed and also a lot of Chinese researchers are being warned against releasing data to foreign journals without proper vetting by Chinese authorities.
https://www.theguardian.com/world/2020/apr/11/china-clamping-down-on-coronavirus-research-deleted-pages-suggest
Thailand Medical News would also like to suggest that more medical research institutions focus on research and clinical trials on the drug ivermectin as informal usage of the drug on COVID-19 patients in many locations has shown positive results at low doses and the drug is non-toxic at low doses.
https://www.thailandmedical.news/news/must-read-covid-19-drug-research-ivermectin-might-emerge-as-one-of-the-most-suitable-drug-candidates-for-covid-19
To date a clinical trial on ivermectin that was done by a US institute that proved to have been successful, has still not released its data publicly.
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