COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15689

Hussein Abdurrazzaq

haderazz05@ymail.com

2021-02-14

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

In order to be eligible to participate in this study, a patient must meet all of the following criteria: (1) Provide written informed consent prior to initiation of any study procedures (2) Understand and agree to comply with planned study procedures (3) Agree to the collection of nasopharyngeal swabs, sputum, and venous blood per protocol (4) Be a male or non-pregnant female adult =18 years of age at the time of enrolment (5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 7 days prior to randomization OR be a household contact (within 7 days) of an individual with lab positive COVID-19 disease.

An individual who meets any of the following criteria will be excluded from participation in this study: 1. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30) 2. Pregnant or breastfeeding. 3. Anticipated transfer to another facility that is not a study site within 72 hours. 4. Participants with known haematological diseases (G6PD deficiency) 5. Participants with chronic liver and kidney disease and reaching end-stage. 6. Participants with arrhythmia and chronic heart disease. 7. Participants known to have or hearing loss. 8. Participants known to have a mental disability. 9. Skin disorders (including rash, dermatitis, psoriasis). 10. Allergy to Ivermectin or its analogues. 11. Participants known to have filaria.

4

Lagos State Ministry of Health

18

80

Nigeria

No restriction on type of patients

0: No restriction on type of patients

240

Primary endpoint: 1. Mortality in both groups on day 72. Resolution of symptoms assessed by clinical status and daily NEWS score until discharge and on Day 7. 3. SARS-CoV-2 clearance time based on samples taken on Days 1; 4; and 6.

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

Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]