Table 5.
Description of the phase III randomized clinical trials which assessed Azithromycin as a treatment against coronavirus disease (COVID)-19.
| Author | Sample | Randomized Participants | Center | Groups | Blindness | Dosage/Duration | Primary Outcome | Results | Conclusions |
|---|---|---|---|---|---|---|---|---|---|
| Cavalcanti et al. (2020) [35] | Hospitalized individuals with suspected or confirmed COVID-19 who were receiving either no supplemental oxygen or a maximum of 4 L/min of oxygen. | A total of 667 individuals were randomized and 504 had confirmed COVID-19. | Multicenter (Brazil). | Three groups: (i) Standard of care; (ii) Standard of care plus Hydroxychloroquine; (iii) Standard of care plus Azithromycin plus Hydroxychloroquine. |
Open-label. | (i) Standard of care; (ii) Standard of care plus Hydroxychloroquine 400-mg twice daily for seven days. (iii) Standard of care plus Hydroxychloroquine 400-mg twice daily plus 500-mg once daily for seven days. |
Clinical status at 15 days was assessed with the seven-level ordinal scale. | In the modified intention to treat (that is, only COVID-19 individuals), Hydroxychloroquine plus Azithromycin did not improve the clinical score at day 15 [OR (95%CI) = 0.99 (0.57 to 1.73). | The use of Hydroxychloroquine plus Azithromycin did not improve the clinical score in patients with COVID-19. |
| Furtado et al. (2020) [36] | Hospitalized participants with confirmed RT-PCR or suspected COVID-19 with at least one of the following characteristics: use of invasive mechanical ventilation OR noninvasive mechanical ventilation OR noninvasive positive pressure ventilation OR oxygen supplementation of more than 4 L/mL flow. | A total of 447 participants were recruited. | Multicenter (Brazil). |
Two groups: (i) 237 participants received Azithromycin plus standard of care; (ii) 210 participants received standard of care. |
Open-label. | - 500-mg Azithromycin once a day for 10 days. - Standard of care. |
Clinical status at 15 days. | Azithromycin plus standard of care versus standard of care did not influence the clinical status at 15 days [OR (95%CI) = 1.36 (0.94 to 1.97)]. | Adding Azithromycin to a standard of care did not result in clinical improvement in hospitalized COVID-19 participants. |
| RECOVERY Collaborative Group (2021) [37] | Hospitalized participants with confirmed RT-PCR or suspected COVID-19. | A total of 7763 participants were recruited. | Multicenter (176 hospitals in the UK). |
Two groups: (i) 2582 participants received Azithromycin; (ii) 5181 participants received usual care. |
Open-label. | - 500-mg Azithromycin once a day for 10 days. - Standard of care. |
28-day-all-cause-mortality. | 28-day-all-cause-mortality—N of people who died (%): 561 (22%) versus 1162 (22%) [Rate ratio (95%CI) = 0.97 (0.86 to 1.07)]. | The results do not show Azithromycin is an effective treatment for hospitalized individuals with COVID-19. |
95%CI, 95% confidence interval; %, percentage; L, liter; OR, odds ratio; mL, milliliters; mg, milligram; N, number of individuals; RT-PCR, real-time polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; UK, United Kingdom.