JOURNAL ARTICLE

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Alexandre B Cavalcanti, Fernando G Zampieri, Regis G Rosa, Luciano C P Azevedo, Viviane C Veiga, Alvaro Avezum, Lucas P Damiani, Aline Marcadenti, Letícia Kawano-Dourado, Thiago Lisboa, Debora L M Junqueira, Pedro G M de Barros E Silva, Lucas Tramujas, Erlon O Abreu-Silva, Ligia N Laranjeira, Aline T Soares, Leandro S Echenique, Adriano J Pereira, Flávio G R Freitas, Otávio C E Gebara, Vicente C S Dantas, Remo H M Furtado, Eveline P Milan, Nicole A Golin, Fábio F Cardoso, Israel S Maia, Conrado R Hoffmann Filho, Adrian P M Kormann, Roberto B Amazonas, Monalisa F Bocchi de Oliveira, Ary Serpa-Neto, Maicon Falavigna, Renato D Lopes, Flávia R Machado, Otavio Berwanger
New England Journal of Medicine 2020 July 23
32706953

BACKGROUND: Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.

METHODS: We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.

RESULTS: A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.

CONCLUSIONS: Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).

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Peter Avvento

Theres a comment section?!??!

9

Stephen Ralph

What if a real estate developer with orange spray paint on says it will cure me though? Never thought about that huh puny New England Journal of Medicine.

4

Hongyun Li

didn not find the test for urine HCQ metabolites

0

Ricardo Gusmão

The protocol is standard. The Likelihood of results is high. On the other hand scientific literacy is medieval and ignorance is far worst and dangerous than covid. I imagine lethality is far higher.
European pharma regulation has modded pharma abuse, free marketing and prohibits idiossincratic opinions Such as those we see everywhere else. You do not see presidents giving ignorant ‘opinions’ on pharmaceuticals nor pseudo-doctors doing the same thing in any country of Europe. There are forums for that.

0

David Avance

How about a Pt who has been on this med for greater 15 years at 200 mg bid

-1

Margaret Grant

What nonsense. Pharma driven nonsense. The correct protocol was not followed. When the 'correct' protocol is *fully followed, the protocol works. Pharma driven looking to its bottom line, and as we all know, pharma 'owns' world governments... Rocket science lies with scientists who are not under the tree of corruption, pharma are not scientists, pharma are finance driven. End of.

-3

Atri Chatterjee

HCQ prophylaxis is associated with lower odds of Covid19 in healthcare workers.

10.4103/ijmr.IJMR_2234_20

-3

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