NCT04390022

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

Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a placebo. The randomization code will be generated by the trial statistician using blocks that ensure balance between the groups. The allocation will be made by the investigator after obtaining informed consent, and confirmation of fulfillment of all inclusion and none of the exclusion criteria. The investigational product will be administered by a researcher not involved in patient care or participant follow up. Participants will remain in the trial for a period of 28 days. In the interests of public health and containing transmission of infection, trial visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members. Subsequent visits will be to assess clinical and laboratory parameters. A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ivermectin	Single dose of STROMECTOL® tablets at 400mcg/kg
DRUG	Placebo	Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.

Timeline

• Start date: 2020-07-31
• Primary completion: 2020-09-17
• Completion: 2020-10-09
• First posted: 2020-05-15
• Last updated: 2020-12-17
• Results posted: 2020-12-17

Locations

1 site across 1 country: Spain