I wonder if there has ever in the history of medicine been such a fanatical resistance to the off-label prescribing of a half century old cheap generic, sold over the counter in many countries for many years. If the fullness of time eventually shows HCQ really was the "Best Medicine" for COVID we'll have in 2020, it will go down as the biggest blunder ever known in the history of medicine.
Just because it helps COVID doesn't make its side effects equally as bad. Ideally you want the disease to be much worse than the cure.
If you have a history of cardiovascular disease, it could very much amount to throwing the dice.
Even if it is shown perfectly safe, it's not clear if it works as a preventative, or a treatment, how much is taken for how long. The medicine isn't actually that popular or well-understood, HCQ is really being cast into the limelight lately.
At least one study has found increased risk of death with HCQ, not surprising given its known cardiotoxic profile and the accruement of damage as treatment drags on.
I don't think this will be viewed as a blunder, even if the risks of cardiac complication can be shown minimal. This will just go down as proper scientific skepticism in the face of an unscientific, cretinous president pushing his fans to lick toilet seats and guzzle bleach. Is the skepticism justified in the face of a man of such outrageous stupidity and broscience? I think so. Is it costing people their lives in a way which is hard to delineate from the start, possibly, and that's just science.
Something new comes on the market, it has to be tested against a variety of genetic conditions, it has to be verified for effectiveness. You don't just rush something to mass production at the first sign of promise. This HCQ parade could quickly turn into an AZT nightmare like so many of the early "treatments" of HIV/AIDS turned out to be dismal relics of the past. No, sorry that's harsh, they were springboards to safer and more effective drugs. That's all.
Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
Mayla Gabriela Silva Borba, Fernando de Almeida Val, Vanderson Sousa Sampaio, Marcia Almeida Araújo Alexandre, Gisely Cardoso Melo, Marcelo Brito, Maria Paula Gomes Mourão, José Diego Brito Sousa, Djane Clarys Baia-da-Silva, Marcus Vinitius Farias Guerra, Ludhmila Abrahāo Hajjar, Rosemary Costa Pinto, Antonio Alcirley Silva Balieiro, Felipe Gomes Naveca, Mariana Simāo Xavier, Alexandre Salomão, André Machado Siqueira, Alexandre Schwarzbolt, Júlio Henrique Rosa Croda, Maurício Lacerda Nogueira, Gustavo Adolfo Sierra Romero, Quique Bassat, Cor Jesus Fontes, Bernardino Cláudio Albuquerque, Cláudio Tadeu Daniel-Ribeiro, Wuelton Marcelo Monteiro, Marcus Vinícus Guimarães Lacerda, CloroCovid-19 Team
Abstract
Background
There is no specific antiviral therapy recommended for the disease caused by SARS-CoV-2 (COVID-19). Recent publications have drawn attention to the possible benefit of chloroquine (CQ). Our study aimed to comprehensively evaluate the safety and efficacy of two different CQ dosages in patients with established severe COVID-19.
Methods
We performed a parallel, double-blinded, randomized, phase IIb clinical trial, aiming to assess safety and efficacy of two different CQ dosages as adjunctive therapy of hospitalized patients with SARS in Manaus, Brazilian Amazon. Eligible participants were allocated to receive orally or via nasogastric tube high dose CQ (600mg CQ twice daily for 10 days or total dose 12g); or low dose CQ (450mg for 5 days, twice daily only on the first day, or total dose 2.7g). In addition, all patients received ceftriaxone and azithromycin. This study was registered with ClinicalTrials.gov, number NCT04323527.
Findings
Out of a pre-defined 440 patients sample size, 81 patients were enrolled. The high dose CQ arm presented more QTc>500ms (25%), and a trend toward higher lethality (17%) than the lower dosage. Fatality rate was 13.5% (95%CI=6.9-23.0%), overlapping with the CI of historical data from similar patients not using CQ (95%CI=14.5-19.2%). In 14 patients with paired samples, respiratory secretion at day 4 was negative in only one patient.
Interpretation
Preliminary findings suggest that the higher CQ dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm. Given the enormous global push for the use of CQ for COVID-19, results such as the ones found in this trial can provide robust evidence for updated COVID-19 patient management recommendations.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
NCT04323527.
It's a retrospective study so is prone to error. Nothing is surprising to me about the 0.33% (I think these antibody studies are overestimating incidence by an order of magnitude sometimes).
People with pre-existing conditions generally avoid others in the pandemic, out of self-concern and malaise, so it is not surprising they are much less infected, and totally not fair to compare with average infection rates of more carefree people.
Additionally, nothing is surprising about seeing no deaths out of 20 positives. Unless they had advanced age, or preexisting heart condition.
Edited by gamesguru, 30 April 2020 - 12:59 PM.