Table 1 Clinical trials investigating Remdesivir
From: FDA efficiency for approval process of COVID-19 therapeutics
Study | Primary Outcome | Strengths | Weaknesses |
|---|---|---|---|
Grein et al. [50] | - Clinical improvement observed in 36 of 53 patients (68%) hospitalized for severe COVID-19 who were given remdesivir | - Rapid organization of a clinical trial to evaluate remdesivir - Patient access to remdesivir therapy - Indicated more studies should be done to further analyze efficacy | - No control group - Small cohort - Unclear patient selection process - Difficult to differentiate adverse side effects from disease progression - Duration of therapy varied - Viral load data not collected |
Beigel et al. [52], (ACTT Trial) | - 31% faster time to recovery in hospitalized patients with severe COVID-19 who received remdesivir compared to the placebo cohort (11 days vs 15 days, rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P < 0.001) - Non-statistically significant mortality benefit with remdesivir (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04; 1059 patients) | -Double-blind, randomized, and placebo-controlled -Large cohort (N = 1062) -Indicated further studies investigating a possible mortality benefit are warranted | - Not able to draw a definite conclusion on the mortality benefit of remdesivir |
Wang et al. [54] | -The use of remdesivir in patients hospitalized with COVID-19 was not associated with an overall difference in time to clinical improvement (hazard ratio 1.23 [95% CI 0·87–1·75], log rank p = .24) indicating that remdesivir does not have statistically significant clinical benefit | - Double-blind, randomized, and placebo-controlled - The non-statistically significant reduction in time to clinical improvement with remdesivir in patients with symptom duration of 10 days or less indicated confirmation in larger studies is warranted | - Small cohort (N = 300) |