Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmissio

Phase 1

• Conditions: COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001474-29-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-08
• Study Completion: 2020-12-10
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

-Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
-Residents of the Pamplona basin (Cuenca de Pamplona”)
-The patient should be between the ages of 18 and 60 years of age
-Negative pregnancy test for women of child bearing age*
-The patient or his/her representative, have given consent to participate in the study.
-The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)

*Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known history of Ivermectin allergy
-Hypersensitivity to any component of Stromectol®
-COVID-19 Pneumonia Diagnosed by the attending physician Identified in a chest X-ray
-Fever or cough present for more than 48 hours
-Positive IgG against SARS-CoV-2 by rapid test
-Age under 18 or
-over 60 years
-Immunosuppression
-Chronic Obstructive Pulmonary Disease
-Diabetes
-Hypertension
-Obesity
-Acute or chronic renal failure
-History of coronary disease
-History of cerebrovascular disease
-Current neoplasm
-Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
-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.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment.;Secondary Objective: 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day seven post treatment<br>2.To assess the efficacy of ivermectin to improve symptom progression in treated patients<br>3.To assess the proportion of seroconversions at day 21 in treated patients<br>4.To assess the safety of ivermectin at the proposed dose<br>5.To determine the magnitude of immune response against SARS-CoV-2 <br>6.To assess the early kinetics of immunity against SARS-CoV-2;Primary end point(s): Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab;Timepoint(s) of evaluation of this end point: Day 7 post-treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Mean viral load as determined by PCR cycle threshold (Ct).<br>2.Proportion of patients with fever and cough, as well as proportion of patients progressing to severe disease or death.<br>3.Proportion of patients with seroconversion.<br>4.Proportion of drug-related adverse events <br>5.Levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, levels of inflammatory and activation markers measured by Luminex and transcriptomics.<br>6.Kinetics of IgG, IgM, IgA levels;Timepoint(s) of evaluation of this end point: Days 4, 7, 14, 21 and 28