Table 1.
Key clinical trials for COVID-19 treatments that are currently under way.
| ACTT [44] | Convalescent Plasma EAP [33] | CORIMUNO-TOCI [39] | Regeneron [40] | |
|---|---|---|---|---|
| Trial ID | NCT04280705 | NCT0433860 | NCT0433180839 | NCT04315298 |
| Study agent | Remdesivir (RDV) | Convalescent plasma | Tocilizumab | Sarilumab |
| Study location | International | USA | France | USA |
| Study design | Adaptive, double-blind, placebo RCT | Open-label expanded access program | Open-label RCT | Adaptive, phase 2/3, randomized, double-blind, placebo-controlled |
| Patients | 1063 randomized (1059 included in preliminary analysis) | 5000 | 129 | 457 |
| Median age, yr (range) | 58.9 | 62.3 (18.5–97.8) | Not reported | Not reported |
| Male patients | RDV: 352 (65.1%); Placebo: 332 (63.6%) | 3153 (63.1%) | Not reported | Not reported |
| Disease status | RDV: 352 (65.1%); Placebo: 332 (63.6%) | Severe or life-threatening: 4051 (81%) High risk of disease progression: 949 (19%) |
Moderate or severe (number not reported) | Severe: 28% Critical: 49% MOD: 23% |
| Baseline clinical status | 127 (11.9%) RA; 421 (39.6%) supplemental oxygen; 197 (18.5%) NIV/HFNC; 272 (25.6%) MV/ECMO | Total ICU admissions: 3316 (66%) Respiratory failure: 2912 (72%) MOD/failure: 745 (18.4%) Septic shock: 600 (14.8%) |
All patients required O2 supplementation, but levels not specified | Not reported |
| Clinical improvement | Median Time to recovery: RDV: 11 days; Placebo: 15 days (p < 0.001); Rate ratio for recovery 1.32 (95% CI 1.12-1.55) | Not reported | Significantly lower proportion of patients in tocilizumab arm met primary outcome (need for NIV or MV) at day 14 | All patients met primary endpoint (% change in CRP): −21% placebo vs −77% sarilumab 200 mg vs −79% sarilumab 400 mg Clinical improvement (critical): 18 (41%) placebo vs 48 (51%) sarilumab 200 mg vs 52 (59%) sarilumab 400 mg |
| Death | Mortality at 14 days: RDV: 7.1% (95% CI, 5-9.9); Placebo: 11.9% (95% CI, 9.2-15.4) | 7-d mortality rate: 14.9% | Significantly lower proportion of patients in tocilizumab arm met primary outcome (death) at day 14 | Critical: 12 (27%) placebo vs 34 (36%) sarilumab 200 mg vs 20 (23%) sarilumab 400 mg |
| Serious adverse events | RDV: 114 (21.1%); Placebo: 141 (27.0%); Most common SAEs - respiratory failure, hypotension, viral pneumonia, AKI | 4 h after transfusion: 36 (<1%) including transfusion-associated circulatory overload (7); transfusion-related acute lung injury (11); severe allergic transfusion reactions | Not reported | No new safety signals |
| Limitations | Complete statistical analysis needed to determine efficacy and safety | No control group; study not designed to assess efficacy of convalescent plasma | Press release with limited preliminary data; not peer-reviewed | Press release with limited preliminary data; not peer-reviewed |
ACTT: Adaptive COVID-19 Treatment Trial AKI: Acute Kidney Injury CI: Confidence Interval EAP: Expanded access program ECMO: Extracorporeal membrane oxygenation HFNC: High-flow nasal cannula ICU: Intensive Care Unit MV: Mechanical Ventilation NIV: Non-invasive Ventilation RA: Room Air RCT: Randomized controlled trial RDV: Remdesivir SAE: Serious Adverse Event.