COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=034-20

Patricia Jannet Garcia

patricia.garcia@upch.pe

2020-07-17

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours, 2. The patient must be elder than 18 years old. 3. Not previous administration of ivermectin before the study. 4. No known history of ivermectin allergy. 5. The patient can give his consent to take part in the study. 6. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.

1. COVID-19 pneumonia • Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles) 2. Positive pregnancy test for women of child bearing age 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 4. Negative SARS-CoV-2 PCR from a nasopharyngeal swab.

2

UNIVERSIDAD PERUANA CAYETANO HEREDIA;

18

100

Peru

Mild disease at enrollment

1: Mild disease at enrollment

68

Outcome name:Use of PCR for SARS-CoV-2. The primary outcome measure will be assessed using Fisher´s exact test.Measure:Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatmentTimepoints:At day 7 post-treatment.

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]