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

NCT04635943 | Completed Phase 2

• 1 other identifier: EC-CNTEI-014-2020
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Coronavirus Infection; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• 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

  7 days post-treatment

Secondary Outcomes (9)

• Mean viral load

  Baseline and on days 4, 7, 14 and 21

• Fever and cough progression

  Up to and including day 21

• Seroconversion at day 21

  Up to and including day 21

• Proportion of drug-related adverse events

  7 days post treatment

• Levels of IgG, IgM and IgA

  Up to and including day 21

Study Arms (2)

Ivermectin

ACTIVE COMPARATOR

Participants on this arm will receive orally one (1) daily dose of ivermectin 300 mcg/kg for three (3) consecutive days, starting at the enrolment visit.

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

Participants on this arm will receive orally one (1) daily dose of placebo for three (3) consecutive days, starting at the enrolment visit.

Drug: Placebo

Interventions

Ivermectin DRUG

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).

Also known as: Noxal

Ivermectin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours.
• years or older.
• No use of ivermectin prior to the study.
• No known history of ivermectin allergy.
• The patient can give his consent to take part in the study.
• 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.

You may not qualify if:

• COVID-19 pneumonia
• Diagnosed by the attending physician (oxygen saturation \< 95% or lung crackles)
• Positive pregnancy test for women of childbearing age\*
• Positive IgG against SARS-CoV-2 by rapid diagnostic test.
• 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)

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (1)

Hospital Nacional Cayetano Heredia

Lima, 15103, Peru

Location

Related Publications (1)

• Garcia PJ, Mundaca H, Ugarte-Gil C, Leon P, Malaga G, Chaccour C, Carcamo CP. Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial. Trials. 2021 Apr 9;22(1):262. doi: 10.1186/s13063-021-05236-2.

  PMID: 33836826 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Ivermectin presentation will be an oral drop solution in a flasks containing 5ml. The placebo presentation will also be an oral drop solution, undistinguishable from ivermectin, but without this device pharmaceutical ingredient. The pharmacist will prepare the treatment flasks (three 5ml flasks per participant), labelling them according to the randomization list in blocks of four (a, b) previously prepared by the epidemiologist, and according to the randomized treatment allocation previously notified by the principal investigator. The participant, investigator and outcomes assessor will be blinded to the study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SAINT-PERU is a triple-blinded, randomized, placebo-controlled trial with two parallel arms to evaluate the efficacy of one daily dose of ivermectin during three consecutive days, administered to patients with a positive PCR test for SARS-CoV-2 in a nasopharyngeal specimen, symptomatic for 96 hours or less, with non-severe COVID-19 disease at baseline, regardless of the presence of risk factors for progression to severity. The efficacy of the drug-based strategy to reduce or block transmission involves treating during early phases of infection, when viral replication is yet limited.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: August 29, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-03

Locations

PE (1)