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| Column | Value |
|---|---|
| Trial registration number | NCT04280705 |
|
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 |
DMIDClinicalTrials@niaid.nih.gov |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-02-21 |
|
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 |
Adaptive |
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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 : Oct. 26, 2020, 11:31 p.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 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: admitted to a hospital with symptoms suggestive of covid-19 infection. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male or non-pregnant female adult > / = 18 years of age at time of enrollment. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either or the following: pcr positive in sample collected < 72 hours prior to randomization; or |
|
Exclusion criteria
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
pcr positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) and progressive disease suggestive of ongoing sars-cov-2 infection. illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or spo2 < / = 94% on room air, or requiring supplemental oxygen, or requiring mechanical ventilation. women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through day 29. agrees to not participate in another clinical trial for the treatment of covid-19 or sars-cov-2 through day 29. |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
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 |
99 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Denmark;Germany;Greece;Japan;Republic of Korea;Mexico;Singapore;Spain;United Kingdom;United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
5: Moderate/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 |
1062 |
|
primary outcome
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Time to Recovery;Time to Recovery by Ethnicity;Time to Recovery by Race;Time to Recovery by Sex |
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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": "Results also posted for EUCTR2020-001052-18: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001052-18/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also posted for EUCTR2020-001052-18: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001052-18/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |