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| Column | Value |
|---|---|
| Trial registration number | NCT04292899 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
GileadClinicalTrials@gilead.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-03 |
|
Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
key inclusion criteria: willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under international conference on harmonization (ich) e6(r2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (irb) or independent ethics committee (iec)) severe acute respiratory syndrome coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) test ≤ 4 days before randomization currently hospitalized peripheral capillary oxygen saturation (spo2) ≤ 94% or requiring supplemental oxygen at screening key |
|
Exclusion criteria
Last imported at : Jan. 3, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- participation in any other clinical trial of an experimental treatment for covid-19 - concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars-cov-2 is prohibited < 24 hours prior to study drug dosing - evidence of multiorgan failure - mechanically ventilated [including veno-venous (v-v) extracorporeal membrane oxygenation (ecmo)] ≥ 5 days, or any duration of veno-arterial (v-a) ecmo. - alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal (uln) - creatinine clearance < 50 ml/min using the cockcroft-gault formula for participants ≥ 18 years of age {cockcroft 1976} and schwartz formula for participants < 18 years of age note: other protocol defined inclusion/exclusion criteria may apply. |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Gilead Sciences |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
12 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
China;France;Germany;Hong Kong;Italy;Japan;Republic of Korea;Netherlands;Singapore;Spain;Sweden;Switzerland;Taiwan;United Kingdom;United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4891 |
|
primary outcome
Last imported at : Jan. 3, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "5 days (not mechanically ventilated); results posted as well on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000841-15/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "10 days (not mechanically ventilated); results posted as well on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000841-15/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "10 days (mechanically ventilated); results posted as well on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000841-15/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "5 or 10 days; results posted as well on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000841-15/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |