RANDOMIZED PHASE IIA CLINICAL TRIAL TO COMPARE THE EFFICACY OF IVERMECTIN VERSUS PLACEBO TO OBTAIN NEGATIVE PCR RESULTS IN PATIENTS WITH EARLY PHASE COVID-19

Not Applicable

Recruiting

• Conditions: -B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-034-20
• Lead Sponsor: IVERSIDAD PERUANA CAYETANO HEREDIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-17
• Study Completion: 2021-04-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified