COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12168

Hussein AbdurRazzaq

Hussein.abdur-razzaq@lagosstate.gov.ng

2020-06-23

Recruiting

RCT

Randomized

Factorial

Blind label

multi-center

Treatment

A. Moderate to Severe COVID-19 disease cases 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 N-P, OP swabs, sputum 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 <7 days prior to randomization. 6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen. 7. If female of childbearing age, should 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. Pregnancy or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Allergy to any study medication

2

Lagos State Government

18

80

Nigeria

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

100

1. SARS-CoV-2 detectable in NP; OP or sputum samples at days 1; 3; 5; 7; 9; & 11.2. Clinical status of subject at day 11 (on a 7-point ordinal scale)• Not hospitalized; no limitations on activities • Not hospitalized; limitation on activities • Hospitalized; not requiring supplemental oxygen • Hospitalized; requiring supplemental oxygen • Hospitalized; on non-invasive ventilation or high flow oxygen devices • Hospitalized; on invasive mechanical ventilation • Death.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]