COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04635943

Patricia García Funegra

Hansel Mundaca, hansel.mundaca@upch.pe (PI email not reported)

2020-11-19

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patients with covid-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours. 18 years or older. no use of ivermectin prior to the study. no known history of ivermectin allergy. the patient can give his consent to take part in the study. not 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.

covid-19 pneumonia diagnosed by the attending physician (oxygen saturation < 95% or lung crackles) positive pregnancy test for women of childbearing age* positive igg against sars-cov-2 by rapid diagnostic test. negative sars-cov-2 pcr from a nasopharyngeal swab. women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study. a woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)

2

Universidad Peruana Cayetano Heredia

18

90

Peru

Mild disease at enrollment

1: Mild disease at enrollment

186

Proportion of patients with a positive SARS-CoV-2 PCR.

None

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"}]