NCT05993143

Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50

A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Insud Pharma · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.

Detailed description

This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups. During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be obtained and the screening procedures will be performed. A rapid antigen-based test will be offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid antigen-based test result at screening (each of these tests may be considered a part of the standard procedure of the site). Eligible subjects will be randomised 1:1 to receive ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on their body weight, and will take the first dose of IP at site. The subjects will receive portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen test results will be communicated to subjects as soon as available. Subjects with negative COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects will be followed up until Day 28. During the follow-up, the subjects will have phone call Visits 4 to 9 every other day, followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen saturation as well as body temperature during all phone call visits and report the respective results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects will return IPs (including empty and partially empty containers) and pulse oximeters. In addition, the subjects will be provided with a contact number available 24/7 to contact the investigator if their condition worsens. In case of health condition worsening (dyspnoea, fever \[body temperature ≥ 37.8°C\] lasting for more than 6 days, SpO2 ≤ 95% or any other worsening criteria based on the investigator's judgement) confirmed during the phone call visit, the subjects will have an unscheduled visit at the site. The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) \< 80 mmHg in gasometry; respiratory frequency \> 20 rpm; fever (body temperature ≥ 37.8°C) for more than 6 days plus one of the following analytic parameters: C-reactive protein (CRP) \> 5 mg/dL, ferritin \> 500 ng/mL or D dimer \> 700 ng/mL. If there is any other condition that requires hospitalisation as per investigator judgement, the condition has to be documented in detail in the subject's file including a description whether the hospitalisation was performed due to SARS-CoV-2 infection.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	Ivermectin	Round and white tablets
DRUG	Placebo	Round and white tablets

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2023-08-15
• Last updated: 2023-08-15

Locations

20 sites across 1 country: Spain