| Trial registration number
|
NCT04328493 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04328493
|
First author
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
Guy Thwaites, PhD. MD
|
Contact
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
Jeremy Day, jday@oucru.org (PI email not reported)
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-03-31
|
Recruitment status
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
multi-center
|
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
|
laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician.
provides written informed consent prior to initiation of any study procedures (or legally authorized representative).
understands and agrees to comply with planned study procedures.
agrees to the collection of op swabs and venous blood per protocol.
male or female adult ≥18 years of age at time of enrollment.
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
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
|
Oxford University Clinical Research Unit, Vietnam
|
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
|
None
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Vietnam
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Moderate/severe disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
4: Moderate/severe disease at enrollment
|
Total sample size
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
10
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Viral clearance time
|
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 2
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|