COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=10928

Hussein AbdurRazzaq

haderazz05@ymail.com

2020-04-02

Not recruiting

RCT

Randomized

Factorial

Blind label

multi-center

Treatment

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Agrees to the collection of OP swabs and venous blood per protocol. 4. Male or non-pregnant female adult =18 years of age at time of enrolment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomisation. 6. Illness of any duration, and at least one of the following: 2.3.3 Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR 2.3.4 Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR 2.3.5 Requiring mechanical ventilation and/or supplemental oxygen. 7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

1. ALT/AST > 5 times the upper limit of normal. 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 3. Pregnant or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Patients with hematological diseases. 6.Patients with chronic liver and kidney disease and reaching end-stage. 7. Patients with arrhythmia and chronic heart disease. 8. Patients known to have retinal disease, hearing loss or hearing loss. 9. Patients known to have a mental illness. 10. Skin disorders (including rash, dermatitis, psoriasis). 11. Allergy to any study medication (4-aminoquinoline).

3

LAGOS STATE GOVERNMENT

19

44

Nigeria

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

800

Status on 7-point ordinal scale

| Declared number of arm (6.0) differs from found arms (7.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]