While announcing that Bayers' chloroquine and Novartis' hydroxychlorquine must prove their benefits vs potential adverse effects in COVID-19 patients before being broadly used, the companies have announced donations of millions of the old antimalarial drugs to governments in a race to bring the cheap old drugs into emergency use - a unsafe experiment according to the German Society of Cardiology. This despite President Donald Trump declaring it a miracle cure after endorsing French Professor Didier Raoult's claims the drug can treat patients.
Novartis, whose generics arms Sandoz is one of several who can produce hydroxychloroquine, said it had reached an agreement with the FDA to proceed with a phase 3 trial of the drug in hospitalised patients with COVID-19. The trial will involve approximately 440 patients and be conducted at more than a dozen sites in the United States.
Some doctors and patients have reported encouraging results.
The coronavirus pandemic has overtaken the globe faster than science can respond.
In some cases, hope has trumped evidence in the worldwide rush to find countermeasures. "He promoted a totally unproven drug again and again, telling Americans desperate to do something, anything to save their lives, what have you got to lose, he said".
The VA researchers also implicitly criticized the Food and Drug Administration for issuing a rare emergency use authorization for hydroxychloroquine "despite limited and conflicting data" on its use and based on "anecdotal and limited observational evidence". He said the Novartis trial is created to test the drug's effectiveness quickly, and could yield results in June. Some 97 patients had been treated with just hydroxycholoroquine, 113 were treated with hydroxycholoroquine and the antibiotic azithromycin and 158 received "standard supportive management" for COVID-19.
The nationwide study, which has not been peer-reviewed, represented the largest analysis so far of hydroxychloroquine, with or without azithromycin, in treating the virus.
Chaisson said numerous clinical trials to research the drug are "either small or uncontrolled or overly ambitious".
At the University of Wisconsin, Madison, "I think we're all rather underwhelmed" at what's been seen among the few patients there who've tried it, said Dr. Nasia Safdar, medical director of infection control and prevention. As it turns out-and as so many people predicted at the time-potentially, a lot.
The NYU Langone study showed that existing QT prolongation did not predict a subsequent QT increase from use of the drugs. But even advanced ECG screening may not reduce the risk. Renal failure was a greater risk factor - indicating the sickest patients are at the greatest risk of risky side effects from the drugs.
