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

Cavalcanti et al., NEJM, doi:10.1056/NEJMoa2019014, COALITION I, NCT04322123

Jul 2020

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Late stage RCT of 667 hospitalized patients with up to 14 days of symptoms at enrollment and receiving up to 4 liters per minute supplemental oxygen, not finding a significant effect after 15 days.

Authors note: "the trial cannot definitively rule out either a substantial benefit of the trial drugs or a substantial harm", sample sizes are too small.

The paper uses the terms mild and moderate, however all patients had serious enough disease to be hospitalized, and 14% were actually randomized in the ICU.

The trial had significant protocol deviations and unusually low medication adherence.

Authors note: "our aim was to exclude patients already receiving longer and potentially therapeutic doses of the study treatments" in explanation for why the study protocol was changed to exclude patients with previous use of the medications >24hrs. Analyzing these patients rather than excluding them may have revealed effectiveness with early use as shown in other studies.

The trial initially required enrollment within 48 hours of admission and was changed to remove this requirement, this change is likely to reduce effectiveness because enrollment was moved later, compared to the time the disease became serious enough for hospitalization. Total HCQ dosage 5.6g.

A correction for 17 errors has been published1.

Important missing comments or errors? Let us know.

risk of death, 57.0% lower, HR 0.43, p = 0.17, treatment 5 of 172 (2.9%), control 7 of 159 (4.4%), adjusted per study, HCQ+AZ vs. HCQ.

risk of death, 44.5% lower, RR 0.55, p = 0.49, treatment 3 of 172 (1.7%), control 5 of 159 (3.1%), NNT 71, HCQ+AZ vs. HCQ, day 15.

risk of mechanical ventilation, 54.0% higher, HR 1.54, p = 0.28, treatment 19 of 172 (11.0%), control 12 of 159 (7.5%), adjusted per study, HCQ+AZ vs. HCQ.

risk of 7-point scale, 18.0% lower, OR 0.82, p = 0.49, treatment 172, control 159, adjusted per study, HCQ+AZ vs. HCQ, RR approximated with OR.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. nejm.org, www.nejm.org/doi/full/10.1056/NEJMx200021.www.nejm.org/doi/full/10.1056/NEJMx200021.

Cavalcanti et al., 23 Jul 2020, Randomized Controlled Trial, Brazil, peer-reviewed, baseline oxygen required 41.8%, 35 authors, study period 29 March, 2020 - 18 May, 2020, trial NCT04322123 (history) (COALITION I).

This Paper Azithromycin All

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'given': 'Fábio F.', 'family': 'Cardoso', 'sequence': 'additional', 'affiliation': [ { 'name': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., ' 'L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., ' 'I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., ' 'F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., ' 'F.R.M.), Hospital Sírio Libanês Research and Education Institute ' '(L.C.P.A.), BP–A Beneficência Portuguesa de São Paulo (V.C.V.), ' 'International Research Center, Hospital Alemão Oswaldo Cruz ' '(A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., ' 'R.D.L.), Hospital...'}]}, { 'given': 'Israel S.', 'family': 'Maia', 'sequence': 'additional', 'affiliation': [ { 'name': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., ' 'L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., ' 'I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., ' 'F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., ' 'F.R.M.), 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'affiliation': [ { 'name': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., ' 'L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., ' 'I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., ' 'F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., ' 'F.R.M.), Hospital Sírio Libanês Research and Education Institute ' '(L.C.P.A.), BP–A Beneficência Portuguesa de São Paulo (V.C.V.), ' 'International Research Center, Hospital Alemão Oswaldo Cruz ' '(A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., ' 'R.D.L.), Hospital...'}]}, { 'given': 'Roberto B.', 'family': 'Amazonas', 'sequence': 'additional', 'affiliation': [ { 'name': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., ' 'L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., ' 'I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., ' 'F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., ' 'F.R.M.), Hospital Sírio Libanês Research and Education Institute ' 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['0028-4793', '1533-4406'], 'subject': ['General Medicine'], 'container-title-short': 'N Engl J Med', 'published': {'date-parts': [[2020, 11, 19]]}}

Late treatment
is less effective

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