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| Column | Value |
|---|---|
| Trial registration number | NCT04539262 |
|
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 : March 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
GileadClinicalTrials@gilead.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-09-04 |
|
Recruitment status
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
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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 |
Blind 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 : March 4, 2022, 9 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 sars-cov-2 infection first confirmed by polymerase chain reaction (pcr) (parts a and b) or by nucleic acid testing or direct antigen testing (part c) with sample collected ≤ 4 days prior to randomization covid-19 symptom onset ≤ 7 days prior to randomization oxygen saturation as measured by pulse oximetry (spo2) > 94% on room air key |
|
Exclusion criteria
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for covid-19 prior or current hospitalization for covid-19 or need for hospitalization treatment of covid-19 with other agents with actual or possible direct antiviral activity against sars-cov-2 including intravenous (iv) rdv or administration of any sars-cov-2 (or covid-19) vaccine participants chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded requiring oxygen supplementation positive pregnancy test breastfeeding female known hypersensitivity to the study treatment, its metabolites, or formulation excipient pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (parts a and b only) note: other protocol defined inclusion/exclusion criteria may apply. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
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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 |
18 |
|
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 |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : March 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
156 |
|
primary outcome
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7;Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7;Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7 |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "31mg", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "62mg", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |