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RECOVERY (AZI, Horby), 2020 NCT04381936

azithromycin (n=2582) vs. standard of care (n=5181)

randomized controlled trial

azithromycin
azithromycin 500 mg once daily by mouth or intravenously for 10 days or until discharge. 16% received another macrolide

standard of care

COVID 19 hospitalized

open label

176 centres, UK

Sekhavati, 2020 IRCT20200415047092N1

azithromycin (n=56) vs. standard of care (n=55)

randomized controlled trial

azithromycine plus lopinavir/ritonavir plus hydroxychloroquine
oral AZM 500 mg daily, oral LPV/r 400/100 mg twice daily and oral HCQ 400 mg daily for 5 days

lopinavir/ritonavir plus hydroxychloroquine
oral LPV/r 400/100 mg twice daily and oral HCQ 400 mg daily for 5 days

COVID 19 hospitalized

open label

1 center, Iran

COALITION I Covid-19 Brazil (AZI, Cavalcanti), 2020 NCT04322123

azithromycin (n=172) vs. standard of care (n=159)

randomized controlled trial

azithromycin plus hydroxychloroquine
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

hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice dailyThe use of glucocorticoids, other immunomodulators, antibiotic agents others than macrolides , and antiviral agents was allowed

3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care

COVID-19 mild to moderate

open-label

Brazil, 55 sites

Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization

Rashad A (AZI vs SoC), 2021

azithromycin (n=107) vs. standard of care (n=99)

randomized controlled trial

azithromycin
azithromycin 500 mg/24 h for 7 days

standard of care

3 arms azithromycin, clarithromycin or standard of care

COVID-19 mild to moderate

open-label

1 centre, Egypt

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.