TABLE 1.
RCTs of remdesivir in COVID-19 (RCTs online published as of 10 May 2022).
| Author, Online time | Trial name, number | Study design | Country | Patients | Amount, randomization | Intervention | Control | Primary endpoint | Conclusion |
|---|---|---|---|---|---|---|---|---|---|
| Cao et al. 29 April 2020 [Wang et al., (2020b)] | NCT04257656 | Randomized, double-blind, placebo- controlled, multicentre trial | China | Adults with laboratory-diagnosed SARS-CoV-2 infection, with an interval from symptom onset to enrolment ≤12 days, SaO2 ≤ 94% or PaO2/FiO2 ≤ 300 mm Hg, and radiology-confirmed pneumonia. | 237, 2:1 (158 to remdesivir and 79 to placebo) | Remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) | The same volume of placebo infusions for 10 days | Time to clinical improvement up to day 28 (6-point ordinal scale) | Remdesivir was not associated with a difference in time to clinical improvement (HR 1.23 [95% CI 0.87–1.75]). |
| 22 May 2020. [Beigel et al., (2020)] | ACTT-1, NCT04280705 | Double-blind, randomized, placebo- controlled trial | United States | Hospitalized adults with lower respiratory tract infection and COVID-19 | 1,062, 1:1 (541 assigned to remdesivir and 521 to placebo) | Remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) | Placebo for up to 10 days | The time to recovery (discharge from the hospital or hospitalization for infection control purposes) with an eight-category ordinal scale | Remdesivir was not associated with a difference in time to clinical improvement (HR 1.23 [95% CI 0.87–1.75]). |
| 27 May 2020. [Goldman et al., (2020)] | The first SIMPLE trial, NCT04292899 | Randomized, open-label, phase 3 trial | Multi-countries | Hospitalized patients with diagnosed COVID-19, SaO2 ≤ 94%. | 397, 1:1 (200 patients for 5 days and 197 for 10 days) | Remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for 4 additional days) | 200-mg loading dose on day 1, followed by 100 mg daily for 9 additional days | Clinical status on day 14 (a 7-point ordinal scale) | There was no significant difference between a 5-day course and a 10-day course of remdesivir in severe COVID-19 patients not requiring mechanical ventilation. |
| 21 August 2020. [Spinner et al., (2020)] | The second SIMPLE trial, NCT04292730 | Three-arm randomized, open-label trial | Multi-countries | Hospitalized patients with moderate COVID-19 confirmed by PCR within 4 days of randomization. | 596, 1:1:1 (197 for 10 days, 199 for 5 days, 200 for standard care) | Remdesivir (200 mg on day 1 followed by 100 mg/d) | Standard care | Clinical status on day 11 (a 7-point ordinal scale) | There was no statistically significant difference in clinical status compared with standard care |
| 15 October 2020. [Consortium et al., (2021)] | Solidarity trial, ISRCTN83971151, NCT04315948 | Large, simple, multi-country, open-label randomized trial | Multi-countries | Hospitalized patients with a diagnosis of COVID-19 and without contra-indication to any study drug. | 11266, not available | Remdesivir (200 mg on day 0 followed by 100 mg/d on day 1–9) | Other study drugs | In-hospital mortality in the 4 comparisons of each study drug vs. its controls | Remdesivir had little or no effect on hospitalized COVID-19 including overall mortality, initiation of ventilation and duration of hospital stay. |
| 11 December 2020. [Kalil et al., (2021a)] | ACTT-2, NCT04401579 | Double-blind, randomized, placebo-controlled trial | United States | Hospitalized adults with COVID-19. | 1,033, 1:1 (515 to combination treatment, 518 to control) | Remdesivir (200 mg loading dose on day 1, followed by a 100 mg dose on day 2–10) plus Baricitinib (4 mg daily dose for 14 days) | Remdesivir plus placebo (the same doses and days as the combination group) | The time to recovery | Baricitinib combined with remdesivir was better than remdesivir alone in reducing recovery time and accelerating improvement in clinical status among COVID-19 patients. |
| 14 September 2021. [Ader et al., (2022)] | EudraCT2020-000936-23, NCT04315948 | Phase 3, open-label, adaptive, multicentre, randomized, controlled trial | Europe | Hospitalized patients with laboratory-diagnosed SARS-CoV-2 infection. | 857, 1:1 (429 to remdesivir plus standard of care and 428 to standard of care only) | Remdesivir (200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to 9 days) | Standard care | The clinical status at day 15 (seven-point ordinal scale of the WHO Master Protocol) | There was no clinical benefit that the use of remdesivir in COVID-19 patients with more than 7 days symptoms, and required oxygen support. |
| 22 December 2021. [Gottlieb et al., (2022)] | NCT04501952 | Randomized, double-blind, placebo-controlled trial | United States | Patients with COVID-19 within the previous 7 days and at least one risk factor for disease progression. | 562, 1:1 (279 patients in the remdesivir group and 283 in the placebo group) | Remdesivir (200 mg on day 1 followed by 100 mg on days 2 and 3) | Placebo (200 mg on day 1, 100 mg on days 2 and 3) | A composite of COVID-19 related hospitalization or death from any cause by day 28 and any adverse event. | A 3-day remdesivir course with acceptable safety and led to an 87% lower risk of hospitalization or death than placebo |
| 22 February 2022. [Ali et al., (2022)] | CATCO (Canadian Treatments for COVID-19), NCT04330690 | Pragmatic, multicentre randomized controlled trial | Canada | Hospitalized patients with COVID-19 | 1,282, 1:1 (634 to remdesivir plus standard care, 648 to standard care alone) | Remdesivir (200 mg intravenously on day 0, followed by 100 mg daily) plus standard care | Standard care | In-hospital mortality | There was no difference in mortality between two groups. |