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

INTERVENTION: Trade Name: Stromectol Product Name: Ivermectina Pharmaceutical Form: Tablet INN or Proposed INN: Ivermectin CAS Number: 70288‐86‐7 Other descriptive name: IVERMECTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: COVID‐19 ; MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: 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. Primary end point(s): Proportion of patients with a positive SARS‐CoV‐2 PCR from a nasopharyngeal swab 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; 2. To assess the efficacy of ivermectin to improve symptom progression in treated patients; 3. To assess the proportion of seroconversions at day 21 in treated patients; 4. To assess the safety of ivermectin at the proposed dose; 5. To determine the magnitude of immune response against SARS‐CoV‐2 ; 6. To assess the early kinetics of immunity against SARS‐CoV‐2 Timepoint(s) of evaluation of this end point: Day 7 post‐treatment SECONDARY OUTCOME: Secondary end point(s): 1. Mean viral load as determined by PCR cycle threshold (Ct).; 2. Proportion of patients with fever and cough, as well as proportion of patients progressing to severe disease or death.; 3. Proportion of patients with seroconversion.; 4. Proportion of drug‐related adverse events ; 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.; 6. Kinetics of IgG, IgM, IgA levels Timepoint(s) of evaluation of this end point: Days 4, 7, 14, 21 and 28 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 Pamplonaâ€�) ‐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? n