COALITION II Covid-19 Brazil (Furtado), 2020 NCT04321278
azithromycin (n=214) vs. standard of care (n=183)
randomized controlled trial
azithromycin plus SoC
azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care including HCQ 400 mg x2 for 10 days
standard of care without macrolide
Soc include HCQ 400 mg x2 for 10 days for all patients
All patients received hydroxychloroquine (400 mg twice daily for 10 days)
COVID-19 severe or critically
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
open-label
57 centres in Brazil
Several sites enrolling patients in this trial were also participating in the COALITION I trial, another randomised study from our group that tested hydroxychloroquine, with or without azithromycin, in patients with mild to moderate COVID-19.14 Investigators were not allowed totransfer patients between trials, and co-enrolment was also not possible because the trials’ inclusion criteria were mutually exclusive.
