Summarized Characteristics of Included Randomized Controlled Trials
| Study (Type) Trial Registration No. | Country (Study Period) | Funding Type (Patient Hospitalization Status) | No. of Patients (Age Range), % Male | Vaccination Status of Patients | Compared Interventions | Outcome |
|---|---|---|---|---|---|---|
| Balykova et al,30 2022 (open label) NR-012022 | Russia (Feb 17, 2021-Jun 1, 2022) | Pharmaceutical: LLC Promomed Rus, Russia (nonhospitalized adults) | 264 (18-80 years), not reported | Not clear | Nirmatrelvir/ritonavir (Skyvira; LLC Promomed Rus) every 12 hours for 5 days compared with no treatment | Clinical progression and viral clearance at 6 days; worsening severity and any adverse events at 16 days |
| Hammond et al,31 2022 (double-blind) NCT04960202 | Various countries (Jul 16-Dec 9, 2021) | Pharmaceutical: Pfizer Inc (nonhospitalized adults) | 2,246 (18-88 years), 51.1 | All patients were unvaccinated irrespective of intervention allocation | Nirmatrelvir/ritonavir (Nirmatrelvir [Pfizer Inc] and ritonavir [Hetero Laboratories]) every 12 hours for 5 days compared with placebo | Hospitalizations and all-cause mortality at 28 days; any adverse events and serious adverse events at 34 days |
| Liu et al,32 2023 (open label) ChiCTR2200058477 | China (Apr 10-May 19, 2022) | Nonpharmaceutical: National Natural Science Foundation of China (hospitalized adults) | 264 (18-90 years), 53.79 | Intervention group (76.52% not vaccinated [2.27% 1 dose; 15.91% 2 doses; 5.3% 3 doses]) Comparator group (70.45% not vaccinated [0.76% 1 dose; 17.42% 2 doses; 11.36% 3 doses]) | Nirmatrelvir/ritonavir (Paxlovid) every 12 hours for 5 days compared with no treatment | Viral clearance and worsening severity at 14 days; all-cause mortality, any adverse events, and serious adverse events at 28 days |
| EPIC-SR,49a 2023 (double-blind) NCT05011513 | Various countries (Aug 2021-Jul 2022) | Pharmaceutical: Pfizer Inc (nonhospitalized adults) | 1,296 (≥18 years), 46 | Not reported | Nirmatrelvir/ritonavir every 12 hours for 5 days compared with placebo | Time to overall sign/ symptom alleviation, hospitalizations or all-cause mortality, duration of hospitalization or intensive care stay, worsening symptoms at 28 days; mortality up to week 24; any adverse events and serious adverse events at 34 days |
EPIC-SR = Evaluation of protease inhibition for COVID-19 in standard-risk patients.
↵a Study report (available online but not peer reviewed).49