A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (SAIVE)

A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19

A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ivermectin Tablets; Drug: Matching placebo tablets

Detailed Description

This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Medical Center Medic Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 65 years, inclusive.
2. Body weight >45 kg.
3. Body Mass Index >18.5.
4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
5. Only one member in the same household will be enrolled.
6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.

Exclusion Criteria:

1. Pregnant or breast-feeding.
2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
4. Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
5. Hypersensitivity to any component of ivermectin.
6. Participants who have been administered ivermectin within 30 days prior to screening.
7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
10. Current use of monoclonal antibodies for the treatment of COVID-19.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching placebo tablets; Daily placebo tablets intake for 28 days
Experimental: Active IMP	Drug: Ivermectin Tablets; Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Prophylaxis	Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28	From Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Symptoms Development	Number of symptomatic Participants according to the WHO COVID-18 scale	From Day 1 to Day 28
COVID-19 Prophylaxis Timeframe	Time to change from baseline in negative RT-PCR to positive RT-PCR	From Day 1 to Day 28
COVID-19 Hospitalisations	Proportion of COVID-19 related hospitalisations	From Day 1 to Day 56
COVID-19 Mortality	Proportion of COVID-19 related mortality	From Day 1 to Day 56
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days	Descriptive comparison of AE rates and severity/seriousness between IVM and placebo	56 days

Collaborators and Investigators

• Sponsor: MedinCell S.A
• Collaborators: Violaine Desort-Hénin, DVM
• Investigators: Principal Investigator: Anna Kostova, MD, Medical Center Medic Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Prophylaxis; RT-PCR test
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: mdc-TTG-CT-002; 2021-001938-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No