Table 2.
Characteristics of analysed trials
| Trial characteristic/baseline characteristics | Number of studies (n/N) or median value | |
|---|---|---|
| Trial intervention | Small-molecule antivirals | 9/44 |
| Pegylated interferon lambda | 3/44 | |
| Convalescent plasma | 2/44 | |
| Repurposed therapies | 16/44 | |
| Monoclonal antibodies | 15a/44 | |
| Number of arms in each study | 2 | 29/44 |
| 3 | 4/44 | |
| 4 | 8/44 | |
| 5 | 2/44 | |
| 6 | 1/44 | |
| Randomization ratio | 1:1 (50%) | 36/68 arms |
| 1:0.818–1:1.22 (45%–55%) | 60/68 arms | |
| Number of participants enrolled per study | All 44 studies | 300 (IQR 149–807, range 56–25 054) |
| Meta-regression analysis (32 studies all patients) | 519 (IQR 223–1138, range 60–25 054) | |
| Median of the average age (years) | 43 (IQR 36–48, range 27–60) | |
| Median of the average symptom duration prior to enrolment (days) | 4 (IQR 3–4.9, range 0–6) | |
| Risk of progression to severe disease (% with risk factors based on US CDC/WHO criteria) | >90 | 14/44 |
| 50–80 | 8/44 | |
| <50 | 22/44 | |
| Infecting SARS-CoV-2 variant(s) | Pre-Delta | 29/44 |
| Delta and/or Omicron | 15/44 | |
| Omicron only | 3/44 | |
| Vaccination status (% receiving at least one dose) | ≥50 | 9/44 |
| <50b | 35/44 | |
| Serological status (% seropositive at baseline across 20 studies reporting these data) | ≥50 | 16/20 |
| <50 | 4/20 | |
| % Seropositive pre-Delta versus Delta/Omicron | 13 (IQR 9.3–26.3) versus 51.2 (IQR 19.8–84) | |
| Baseline pharyngeal viral swab eluate density, copies/mL (median of mean or median) | Intervention arms | 1 000 000 copies/mL (IQR 112 202–3 630 781, range 4266–134 896 288) |
| Control arms | 851 138 copies/mL (IQR 97 724–4 265 795, range 1000–95 499 259) | |
| Clinical endpoints (across 32 studies with ≥1 clinical endpoint in each arm included in the meta-regression analysis) | Reported all-cause hospitalization or death | 24/32 |
| Reported COVID-19-related hospitalization or death | 6/32 | |
| Reported COVID-19-related ED visits or hospitalizationsc | 1/32 | |
| Serious adverse events extracted as proxy for all-cause hospitalization or death | 1/32 | |
| Sampling technique | Nasopharyngeal | 26/44 |
| Oropharyngeal | 7/44 | |
| Nasal | 9/44 | |
| Saliva | 2/44 | |
| RT–PCR assay LLOQ across 15 studies reporting this information (log10 copies/mL) | Range of LLOQ | 2.3–3 |
| Range of values imputed for viral loads below LLOQ | 1.7–3.27 | |
| Post-baseline viral load sampling (latest timepoint within the first 8 days post-randomization) | Day 7/8 | 33/44 |
| Day 5/6 | 10/44 | |
| Day 4 | 1/44 | |
| Viral density data used for rate of clearance estimation | Median viral load data | 20/44 |
| Mean viral load data | 17/44 | |
| Least-squares mean change from baseline | 7/44 | |
ED, emergency department; LLOQ, lower limit of quantification.
aOne study included both remdesivir and casirivimab/imdevimab.18
bIn 10 studies where baseline vaccination status was not reported, the patients were assumed to be predominantly unvaccinated based on the time when the study was conducted.
cSince 12 out of the 15 total ED visits/hospitalizations in the BLAZE-1 study were hospitalizations, this composite endpoint was considered largely comparable to the endpoints in other studies.