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Recent:   

Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial

Furtado et al., The Lancet, doi:10.1016/S0140-6736(20)31862-6, COALITION II, NCT04321278
Sep 2020  
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Mortality, day 29 -8% Improvement Relative Risk Mortality, day 15 -3% 6 point scale, day 29 30% 6 point scale, day 15 26% primary Azithromycin  COALITION II  LATE TREATMENT  RCT Is late treatment with azithromycin beneficial for COVID-19? RCT 397 patients in Brazil No significant difference in mortality c19early.org Furtado et al., The Lancet, September 2020 Favorsazithromycin Favorscontrol 0 0.5 1 1.5 2+
Small RCT comparing the addition of AZ for very late stage patients on ventilation or oxygen. One notable result is that even within this extremely late stage population, results suggest increased efficacy with the addition of AZ for patients with earlier use of AZ/HCQ, OR 0.71 [0.25-2.03] (Figure S4).
Patients received 8g of HCQ over 10 days, approaching the high levels used in the RECOVERY trial (9.2g over 10 days), showing significantly more adverse events than typical trials. 50% of patients were on mechanical ventilation at baseline.
More than the increase in mortality at day 29 occurred on day 0, and more than 3x the increase occurred by day 2.
risk of death, 8.0% higher, HR 1.08, p = 0.63, treatment 90 of 214 (42.1%), control 73 of 183 (39.9%), day 29.
risk of death, 2.6% higher, RR 1.03, p = 0.91, treatment 66 of 214 (30.8%), control 55 of 183 (30.1%), day 15.
6 point scale, 30.1% lower, OR 0.70, p = 0.08, treatment 214, control 183, inverted to make OR<1 favor treatment, day 29, RR approximated with OR.
6 point scale, 26.5% lower, OR 0.74, p = 0.10, treatment 214, control 183, inverted to make OR<1 favor treatment, day 15, primary outcome, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Furtado et al., 4 Sep 2020, Randomized Controlled Trial, Brazil, peer-reviewed, 33 authors, average treatment delay 8.0 days, trial NCT04321278 (history) (COALITION II).
This PaperMiscellaneousAll
Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial
Remo H M Furtado, Dr Otavio Berwanger, Henrique A Fonseca, Thiago D Corrêa, Leonardo R Ferraz, Maura G Lapa, Fernando G Zampieri, Viviane C Veiga, Luciano C P Azevedo, Regis G Rosa, Renato D Lopes, Alvaro Avezum, Airton L O Manoel, Felipe M T Piza, Priscilla A Martins, Thiago C Lisboa, Adriano J Pereira, Guilherme B Olivato, Vicente C S Dantas, Eveline P Milan, Otavio C E Gebara, Roberto B Amazonas, Monalisa B Oliveira, Ronaldo V P Soares, Diogo D F Moia, Luciana P A Piano, Kleber Castilho, Roberta G R A P Momesso, Guilherme P P Schettino, Luiz Vicente Rizzo, Ary Serpa Neto, Flávia R Machado, Alexandre B Cavalcanti
The Lancet, doi:10.1016/s0140-6736(20)31862-6
Background The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19. Methods We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1•00 favouring the control group). The primary outcome was assessed in all patients in the intentionto-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278. Findings 447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1•36 [95% CI 0•94-1•97], p=0•11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups. Interpretation In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19. Funding COALITION COVID-19 Brazil and EMS.
COVID-19 Brazil. EMS provided partial funding, the study drugs, and coordinated logistics for the trial, but was not involved in the study conduct, analysis, or decision to publish these results. The authors vouch for the integrity and completeness of the data and the fidelity of the trial to the protocol.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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