COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12147

Olobayo Kunle

kunleoo@hotmail.com

2020-06-12

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

. Hospitalized patients with PCR- documented SARS-CoV-2 RNA from throat /nasopharyngeal swab, samples 2. Aged between 18-80 years old 3. the weight is more than 30kg, and there is no limit for men and women 4. Patients who meet the following conditions: creatinine = 110 umol / L, creatinine clearance rate (EGFR) = 60 ml / min / 1.73m2, 5. AST and ALT = 5 × ULN 6. TBIL = 2 × ULN, 7. Patients who are able to fully understand the purpose, nature, method of the study and the possible reactions to the study drugs, voluntarily participate in the study and sign the informed consent 8. Not having severe acute respiratory syndrome (SARS) 9. Patients not using mechanical ventilation or supplemental oxygen, with peripheral oxygen saturation >94% in room air, and having a respiratory rate below 24 incursions per minute. 6. A Normal ECG Baseline result which remains same throughout the study.

1.Hypersensitivity reaction to chloroquine, 4-aminoquinolines or azithromycin and ivermectin 2.Shortness of breath in resting position 3. Known prolonged QT syndrome 4. Active or clinically significant cardiac disease including congestive heart failure. 5. History or current evidence of clinically significant cardiac arrhythmia, atrial fibrillation or paroxysmal supraventricular tachycardia 6. Use of concomitant medications that prolong the QT/QTc interval 7. Elevated levels of troponin I, Creatinine kinase MB, and Myoglobin 8. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 9. Already receiving chloroquine or azithromycin 10. Patients with other viral pneumonia 11. Patients who have received organ transplantation or surgery planning in the past 6 months 12. Patients who can't take food or drugs due to coma or intestinal obstruction 13. Patients who have severe underlying diseases that affect survival including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding and severe malnutrition 14. Patients that are pregnant or lactating 15. Patients (including male Patients) having a pregnancy plan (including plans for sperm donation or egg donation) 16. Patients that may fail to take effective contraceptive measures within the next 6 months 17. Patients with allergies to macrolides and chloroquine tablets 18. Patients with contraindications to the test drugs. 19. Patients who are using drugs that interact with the test drugs. 20. Patients using drugs associated with severe and/or life-threatening events [with a narrow therapeutic index] 21. Patients with cirrhosis or pancreatitis 22. Patients with Creatinine QUOTE >110 umol/l 23. Patients with decreased liver function 24. Patients who in the opinion of the investigators after assessing all relevant parameters are unsuitable for the study.

3

National Institute for Pharmaceutical Research and Development NIPRD

18

80

Nigeria

Mild disease at enrollment

1: Mild disease at enrollment

210

The rate of virus inhibition [Time Frame: Day 0; 4; 7; 14 and 21]Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.Time (days) from randomization to recovery defined asAbsence of symptoms of greater than mild severity for 24 hours Not requiring supplemental oxygen beyond pre-COVID baseline

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1543, "treatment_name": "Azithromycin+hydroxychloroquine+zinc", "treatment_type": "Antibiotics+antimalarials+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1606, "treatment_name": "Azithromycin+lopinavir+ritonavir+zinc", "treatment_type": "Antibiotics+antivirals+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]