Cochrane · systematic review · CD015395
Nirmatrelvir combined with ritonavir for preventing and treating COVID‐19
Reis, S, Metzendorf, M-I, Kuehn, R, et al. · Cochrane Database of Systematic Reviews · 2023 · Cochrane Library
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
22
current version
GRADE rated
9
No studies
13
Included studies
NR
No studies 13 · 59.1%Ungraded 0 · 0%Very low 3 · 13.6%Low 3 · 13.6%Moderate 3 · 13.6%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Current version onlyNirmatrelvir/ritonavir for treating people with asymptomatic or mild COVID‐19 in outpatient settings
Population: unvaccinated, non‐hospitalized people with mild symptomatic COVID‐19 (WHO scale 2 to 3) at high risk for progression to severe disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
All‐cause mortality at day 28 | RR 0.04 [0, 0.68] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Admission to hospital or death | RR 0.13 [0.07, 0.27] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Admission to ICU or death | no estimate extracted | NR | No studies |
All initial symptoms resolved at 28 days, and up to the longest | no estimate extracted | NR | No studies |
Time to symptom resolution | no estimate extracted | NR | No studies |
Quality of life up to 28 days and longest | no estimate extracted | NR | No studies |
SAEs during the study period | RR 0.24 [0.15, 0.41] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Any grade TEAE | RR 0.95 [0.82, 1.1] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Any grade TRAE | RR 2.06 [1.44, 2.95] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Discontinuation of study drug due to adverse events | RR 0.49 [0.3, 0.8] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Viral clearance at 14 days | no estimate extracted | NR | No studies |
Nirmatrelvir/ritonavir for treating people with moderate to severe COVID‐19 in inpatient settings
Population: hospitalized people with mild to moderate symptomatic COVID‐19 (WHO scale 2 to 4) with severe comorbidities
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
All‐cause mortality at day 28 | RR 0.63 [0.21, 1.86] | 1 study · 264 participants | Very low Downgraded: imprecision, indirectness |
Participants with new need for invasive mechanical ventilation or death | no estimate extracted | NR | No studies |
Participants discharged alive. Participants should be discharged without clinical deterioration or death | no estimate extracted | NR | No studies |
Quality of life up to 28 days and longest | no estimate extracted | NR | No studies |
SAEs during the study period | no estimate extracted | NR | No studies |
Any grade TEAE | no estimate extracted | NR | No studies |
Any grade TRAE | no estimate extracted | NR | No studies |
Discontinuation of study drug due to adverse events | no estimate extracted | NR | No studies |
Viral clearance | no estimate extracted | NR | No studies |
Viral clearance at 7 days | RR 1.06 [0.71, 1.58] | 1 study · 264 participants | Very low Downgraded: imprecision, indirectness |
Viral clearance at 14 days | RR 1.05 [0.92, 1.2] | 1 study · 264 participants | Very low Downgraded: imprecision, indirectness |
Nirmatrelvir/ritonavir for treating COVID‐19 in outpatient settings with asymptomatic or mild disease
Population: unvaccinated, nonhospitalized people with mild symptomatic disease (WHO scale 2 to 3) at high risk for progression to severe disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
All‐cause mortality at day 28 | RR 0.04 [0, 0.68] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Admission to hospital or death within 28 days | RR 0.13 [0.07, 0.27] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Admission to intensive care unit (ICU) or death within 28 days | no estimate extracted | NR | No studies |
All initial symptoms resolved at 28 days, and up to the longest | no estimate extracted | NR | No studies |
Time to symptom resolution | no estimate extracted | NR | No studies |
Quality of life up to 28 days and longest | no estimate extracted | NR | No studies |
Serious adverse events during the study period | RR 0.24 [0.15, 0.41] | 1 study · 2224 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Adverse events | no estimate extracted | NR | No studies |
Any grade treatment‐emergent adverse events (TEAE) during the study period | RR 0.95 [0.82, 1.1] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Any grade treatment‐related adverse events (TRAE) during the study period | RR 2.06 [1.44, 2.95] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Discontinuation of study drug due to adverse events | RR 0.49 [0.3, 0.8] | 1 study · 2224 participants | Moderate Downgraded: risk of bias, imprecision, indirectness |
Viral clearance at 14 days | no estimate extracted | NR | No studies |