Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial

NCT04390022 | Completed Phase 2 Results

• 1 other identifier: SAINT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

Conditions

Covid-19; Coronavirus Infection; SARS-CoV-2 Infection

Keywords

ivermectin

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. PCRs were performed using two target genes (E and N).

  7 days post-treatment

Secondary Outcomes (8)

• Median Viral Load

  Baseline and on days 4, 7, 14 and 21

• Fever and Cough Progression

  Days 4, 7, 14 and 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 28

Study Arms (2)

Ivermectin

ACTIVE COMPARATOR

Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.

Drug: Placebo

Interventions

Ivermectin DRUG

Single dose of STROMECTOL® tablets at 400mcg/kg

Also known as: Stromectol

Ivermectin

Placebo DRUG

Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 aged 18 to 59 years
• 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)

You may not qualify if:

• 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
• The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):
• Immunosuppression
• Chronic Obstructive Pulmonary Disease
• Diabetes
• Hypertension
• Obesity
• Acute or chronic renal failure

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31108, Spain

Location

Related Publications (1)

• Chaccour C, Casellas A, Blanco-Di Matteo A, Pineda I, Fernandez-Montero A, Ruiz-Castillo P, Richardson MA, Rodriguez-Mateos M, Jordan-Iborra C, Brew J, Carmona-Torre F, Giraldez M, Laso E, Gabaldon-Figueira JC, Dobano C, Moncunill G, Yuste JR, Del Pozo JL, Rabinovich NR, Schoning V, Hammann F, Reina G, Sadaba B, Fernandez-Alonso M. The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial. EClinicalMedicine. 2021 Feb;32:100720. doi: 10.1016/j.eclinm.2020.100720. Epub 2021 Jan 19.

  PMID: 33495752 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

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

Results Point of Contact

• Title: Carlos Chaccour
• Organization: Barcelona Institute for Global Health

carlos.chaccour@isglobal.org

0034666293112

Study Officials

• Carlos J Chaccour, MD PhD

  Clinica Universidad de Navarra and Barcelona Institute of Global Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 15, 2020
• Study Start: July 31, 2020
• Primary Completion: September 17, 2020
• Study Completion: October 9, 2020
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Locations

ES (1)