Table 1.
Ongoing clinical trials registered under United States National Library of Medicine clinical trials registry and addressing the safety and efficacy of remdesivir (GS-5734™) as a potential therapeutic option for COVID 19.
| Clinical trial identifier | Study design | Estimated enrollment |
Phase of the study | Conditions | Interventions | Primary outcome measures | Recruitment status | |
|---|---|---|---|---|---|---|---|---|
| Experimental arm | Comparator (control) arm | |||||||
|
NCT04292899 (Gilead-Sciences, 2020b) |
Randomized, open label clinical trial | 400 | Phase 3 | Severe COVID 19 |
Arm 1: Remdesivir IV infusion for 5 Days + standardized care Arm 2: Remdesivir IV infusion 10 Days |
Active: No placebo | Composite outcome measure (proportion of participants with normalization of fever and oxygen saturation through day 14) | Recruiting |
|
NCT04292730 (Gilead-Sciences, 2020c) |
Randomized, open label clinical trial | 600 | Phase 3 | Moderate COVID 19 |
Arm 1: Remdesivir IV infusion for 5 Days + standardized care Arm 2: Remdesivir IV infusion 10 Days |
Arm 3: Active (Standard of Care) |
Proportion of participants discharged by day 14 | Recruiting |
|
NCT04252664 (Cao, 2020a) |
Randomized, Double-blind, Placebo-controlled clinical trial | 308 | Phase 3 | Mild and Moderate COVID 19 |
Arm 1: Remdesivir IV for 10 Days (200 mg loading dose for day 1 followed by 100 mg IV for 9 days) |
Arm 2: Placebo that match remdesivir in dose and duration | Time to clinical recovery (TTCR) Upto 28 days | Recruiting |
|
NCT04257656 (Cao, 2020b) |
Randomized, Double-blind, Placebo-controlled clinical trial | 453 | Phase 3 | Severe COVID 19 |
Arm 1: Remdesivir IV for 10 Days (200 mg loading dose for day 1 followed by 100 mg IV for 9 days) |
Arm 2: Placebo that match remdesivir in dose and duration | Time to Clinical Improvement (TTCI) [Censored at Day 28] | Completed |
|
NCT04280705 (NIAID, 2020) |
Adaptive, Randomized, double Blind Controlled Trial | 394 (1:1) | Phase 3 | Hospitalized patients with COVID 19 (no specific severity) |
Arm 1: 200 mg RDV IV for day 1 followed by 100 mg IV QD for 9 days | Arm 2: Placebo that match remdesivir in dose and duration | Percentage of subjects reporting each severity rating on the 7-point ordinal scale within 15 days | Recruiting |
|
NCT04302766 (US-AMRDC, 2020) |
Expanded access | General (Intermediate-size Population) | NA | Any COVID 19 case | Not stated | Not stated | NA | Available |
|
NCT04315948 (DisCoVeRy trial) (INSERM, 2020) |
Adaptive, Randomized, Open label clinical Trial | 3200 | Phase 3 | COVID-19 in hospitalized adults |
Arm 1: 200 mg RDV IV for day 1 followed by 100 mg IV QD for 9 days Arm 2: Lopinavir/ritonavir (400 mg/100 mg) tablet BID for 14 days Arm 3: Lopinavir/ritonavir (400 mg/100 mg) tablet BID for 14 days plus Interferon ß-1a 44 ug subcutaneously in total of three doses (Day 1, 3 and 6) |
Arm 4: (Active) Standard of care |
Percentage of subjects reporting each severity rating on a 7-point ordinal scale within 15 days | Not yet recruiting |