Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19

Universidad Peruana Cayetano Heredia186 enrolled

Overview

SAINT-PERU is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.

SAINT is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru. The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and 93 to the placebo group. Participants will be randomized to receive one dose of 300 mcg/kg ivermectin or placebo daily for three consecutive days. The epidemiologist will generate a list of correlative numbers, in randomized blocks of size 4, with the assignment to the treatment groups (a and b). The randomization list will be kept in an encrypted file accessible only to the trial statistician. This list will be handed directly to the pharmacist. Independently, the principal investigator will randomly assign the intervention (ivermectin) to one of the two groups (a or b) by tossing a coin, and will inform the pharmacist of the result of this process. The pharmacist will prepare and label the treatment vials according to the randomization list prepared by the epidemiologist and the treatment assignment given by the principal investigator. Eligible patients will be allocated in a 1:1 ratio using this randomization list. Participants are expected to remain in the trial for a period of 21 days. In the interests of public health and containing transmission of infection, follow-up visits will be conducted by the trial medical staff at the participant's home or at a hospital in case of hospitalization. Follow-up visits will assess clinical and laboratory parameters of the patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Covid19 Coronavirus Infection SARS-CoV Infection

Interventions

IvermectinDRUG

One daily dose of NOXAL-Ivermectin Oral Solution (6 mg/mL) at 300mcg/kg for three (3) consecutive days. A weight-equivalence table will be used to determine each participant´s dose (number of oral drops/day).

PlaceboDRUG

The placebo presentation will be an oral drop solution undistinguishable from ivermectin, but without this device pharmaceutical ingredient.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours. 2. 18 years or older. 3. No use of ivermectin prior to the study. 4. No known history of ivermectin allergy. 5. The patient can give his consent to take part in the study. 6. 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. Exclusion Criteria: 1. COVID-19 pneumonia * Diagnosed by the attending physician (oxygen saturation \< 95% or lung crackles) 2. Positive pregnancy test for women of childbearing age\* 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 4. 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)

Locations (1)

Hospital Nacional Cayetano Heredia

Lima, Peru

Outcomes

Primary Outcomes

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

Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment

Time frame: 7 days post-treatment

Secondary Outcomes

Mean viral load

Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab

Time frame: Baseline and on days 4, 7, 14 and 21

Fever and cough progression

Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial

Time frame: Up to and including day 21

Seroconversion at day 21

Proportion of participants with positive IgG at day 21

Time frame: Up to and including day 21

Proportion of drug-related adverse events

Time frame: 7 days post treatment

Levels of IgG, IgM and IgA

Time frame: Up to and including day 21

Frequency of innate immune cells

Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry

Time frame: Up to and including day 7

Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells

Data from ClinicalTrials.gov

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