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Trial - NCT04860284


Column Value
Trial registration number NCT04860284
Full text link
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04860284

First author
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Pauline Byakika-Kibwika

Contact
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-26

Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients with a confirmed positive polymerase chain reaction(pcr) test for sars cov-2 - adults of ≥ 18 years - evidence of a personally signed and dated informed consent document indicating that the participant(or their legal representative) has been informed of all pertinent aspects of the study

Exclusion criteria
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- patients with contraindication to the use of hydroxychloroquine e.g. known allergy to hydroxychloroquine - patients enrolled in another interventional study which may interfere with study results - patients on medication that are known to have clinically significant interactions with the study drug e.g. digoxin, piperaquine, lumefantrine. - patients presenting with severe/critically ill covid-19 (world health organization ordinal scale for clinical improvement score of 5 or more) - patients with a fever( temperature ≥ 37.5 degrees centigrade) and a positive rapid diagnostic test (rdt) result for malaria - patients with corrected qt interval (qtc) prolongation of > 450ms for males and >470ms for females - pregnant or breastfeeding women - patients on chronic hydroxychloroquine use

Number of arms
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Makerere University

Inclusion age min
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Uganda

Type of patients
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

105

primary outcome
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

SARS COV-2 viral clearance

Notes
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : April 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "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"}]