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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-034-20
Enrollment
68
Registered
2020-07-17
Start date
2020-07-09
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

IVERMECTIN Type of group
The participants will receive one (1) daily dose of 300 mcg/kg ivermectina for three (3) consecutive days. The Ivermectin presentation will be an oral drop solution. Group name:Ivermectin placebo Type of group
The participants will receive one (1) daily dose of an ivermectin placebo for three (3) consecutive days. The placebo presentation will be an oral drop solution undistinguishable

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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-treatment Timepoints:At day 7 post-treatment.

Secondary

MeasureTime frame
Outcome name:The study will use the burden and proportion of intestinal parasites. Measure:Instestinal parasites by means of cuatitative kato-kats and Baerman. Timepoints:At day 1 and 14 ; Outcome name:The mean viral load as determined by PCR clycle threshold (Ct) will be used. Measure:Viral load as determined by PCR cycle threshold (Ct). Timepoints:At baseline and on days 4, 7, 14, and 21 ; Outcome name:The proportion of patients with fever an cough will be used. Measure:Patients with fever and cough Timepoints:At days 4, 7, 14 and 21 post-treatment ; Outcome name:The proportion of patients with seroconversion will be used Measure:Patients with seroconversion Timepoints:At day 21 ; Outcome name:The study will use the proportion of drugrelated adverse events. Measure:Drug-related adverse events Timepoints:During the entire study

Countries

Peru

Contacts

Public ContactPatricia Jannet Garcia

UNIVERSIDAD PERUANA CAYETANO HEREDIA

patricia.garcia@upch.pe991886872

Outcome results

None listed

Source: REPEC (via WHO ICTRP) · Data processed: Feb 23, 2026