Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see Clinical Studies (14) ] : Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. FDA label
Also known as Remdesivir (RDV), GS-5734™, Veklury®
Remdesivir · 5 trials · 4 indications
Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.
Primary estimates: Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat \<94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency \> 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound.
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days. The laboratory abnormalities were graded using division of allergy and infectious diseases (DAIDS) scale. DAIDS scale is used to grade the severity of adult and pediatric unwanted medical events. Grade 1: mild event, Grade 2: moderate event, Grade: serious event, Grade 4: potentially life-threatening event.
Cmax is defined as maximum plasma concentration of drug. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.
AUCtau is defined as area under the concentration versus time curve over the dosing interval. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.
Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
| Arm | Type | Description |
|---|---|---|
| Part A: Remdesivir (RDV), 5 Days | EXPERIMENTAL | Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5. |
| Part A: Remdesivir, 10 Days | EXPERIMENTAL | Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. |
| Part A: SOC Therapy | ACTIVE_COMPARATOR | Participants will receive continued standard of care therapy. |
| Part B: Extension Treatment, Remdesivir 10 Days | EXPERIMENTAL | Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10. |
| Part B: Remdesivir, 10 Days (Extension) | EXPERIMENTAL | Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10. |
| Part B: Remdesivir 10 days (Mechanically Ventilated) | EXPERIMENTAL | Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10 |
| Single Arm | EXPERIMENTAL | Single Arm with remdesivir |
| Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg | EXPERIMENTAL | Participants will receive RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days. |
| RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg | EXPERIMENTAL | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | EXPERIMENTAL | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | EXPERIMENTAL | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| RDV, Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | EXPERIMENTAL | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | EXPERIMENTAL | Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days. |
| RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | EXPERIMENTAL | Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days. |
| RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | EXPERIMENTAL | Participants will receive RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
| Remdesivir (RDV), Part A | EXPERIMENTAL | Participants will receive inhaled RDV 31 mg administered daily for 5 days. |
| RDV + Placebo, Part A | EXPERIMENTAL | Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days. |
| Placebo, Part A | PLACEBO_COMPARATOR | Participants will receive placebo to match inhaled RDV in Part A daily for 5 days. |
| RDV, Part B | EXPERIMENTAL | Participants will receive inhaled RDV 62 mg administered daily for up to 5 days. |
| RDV + Placebo, Part B | EXPERIMENTAL | Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days. |
| Placebo, Part B | PLACEBO_COMPARATOR | Participants will receive placebo to match inhaled RDV in Part B daily for 5 days. |
| RDV, Part C | EXPERIMENTAL | Participants will receive inhaled RDV 39 mg administered daily for 5 days. |
| Placebo, Part C | PLACEBO_COMPARATOR | Participants will receive placebo to match inhaled RDV in Part C daily for 5 days. |
| Name | Type | Description |
|---|---|---|
| Remdesivir | DRUG | Administered as an intravenous infusion |
| Standard of Care | DRUG | Standard of Care Treatment for COVID-19 Infection |
| Remdesivir (RDV) | DRUG | Participants will receive their first dose of remdesivir also within the 24 (+/-12) hours prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed by 100 mg daily from days 2 to 10, for a total of 10 days. |
| Placebo | DRUG | Administered as an aerosolized solution |
Key Inclusion Criteria: * Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and \< 18 years of age) prior to performing study procedures. For participants ≥ 12 and \< 18 years of age, a parent or l...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Remdesivir is an antiviral medicine studied and used for the treatment of COVID-19, the disease caused by SARS-CoV-2 infection. It has been evaluated in hospitalized patients with severe COVID-19 as well as in early-stage disease, in adults and in participants below 18 years old.
Remdesivir is developed and manufactured by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the clinical trial program evaluating the drug in COVID-19, including the Phase 3 study in participants with severe disease.
Remdesivir has been studied in Phase 3 clinical development for COVID-19. Its trial program includes a completed Phase 3 study in participants with severe COVID-19, completed Phase 2 and Phase 1 studies, and a Phase 2 study in kidney transplant patients that is currently recruiting.
Remdesivir trials include NCT04292899, a completed Phase 3 study in severe COVID-19 with 4,891 participants, NCT04431453, a completed Phase 2 study in participants below 18, NCT04539262, a completed Phase 1 inhaled formulation study, and NCT07197164, a recruiting Phase 2 trial in kidney transplant patients in Spain.
Yes, RDV is a common abbreviation for Remdesivir. The two names refer to the same antiviral drug developed by Gilead Sciences, Inc. for COVID-19, so searches for either term point to the same compound and clinical program.
Across the reported Remdesivir studies, total enrollment is approximately 6,234 participants. The largest is the completed Phase 3 trial NCT04292899 with 4,891 participants, followed by the completed Phase 1 inhalation study with 156 and the completed pediatric Phase 2 study with 59.