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Trial - NCT04360759


Column Value
Trial registration number NCT04360759
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04360759

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Sean Wasserman, MBChB;Graeme Meintjes, PhD

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Nompumelelo Maxebengula, mpumi.maxebengula@uct.ac.za (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-24

Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Withdrawn

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - tested for covid-19 at a trial recruitment site as an outpatient; - age 18 years or older; - not requiring immediate hospitalisation; - mild disease, defined as respiratory rate <25/min, pulse rate <120/min, spo2 >94%; - hiv-positive by rapid test or documented history; - suspected or confirmed covid-19; - signed informed consent.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- covid-19 diagnosed > 5 days prior to randomization; - active tuberculosis; - need for concomitant drugs that are contraindicated with the use of chloroquine/hydroxychloroquine; - qtcf interval > 480 ms; - known glomerular filtration rate < 10 ml/min; - known with glucose-6-phosphate dehydrogenase deficiency (g6pd); - previous adverse drug reaction to investigational product; - concurrent involvement in other research or use of chloroquine, hydroxychloroquine or any other 4-aminoquinolone or another experimental investigational medicinal product that is likely to interfere with the study medication. note: pregnancy and breastfeeding are not exclusions for entry

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

University of Cape Town

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

South Africa

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Event-free survival at 28 days post-randomization between experimental group and standard of care group

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 3

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"}]