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

NCT05305560 | Completed Phase 2 Results DMC

• 2 other identifiers: mdc-TTG-CT-0022021-001938-19
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

Prophylaxis; RT-PCR test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• COVID-19 Symptoms Development

  From Day 1 to Day 28

• COVID-19 Prophylaxis Timeframe

  From Day 1 to Day 28

• COVID-19 Hospitalisations

  From Day 1 to Day 56

• COVID-19 Mortality

  From Day 1 to Day 56

• To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days

  56 days

Study Arms (2)

Active IMP

EXPERIMENTAL

Drug: Ivermectin Tablets

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo tablets

Interventions

Ivermectin Tablets DRUG

Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.

Active IMP

Matching placebo tablets DRUG

Daily placebo tablets intake for 28 days

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Pregnant or breast-feeding.
• A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
• 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.
• Hypersensitivity to any component of ivermectin.
• Participants who have been administered ivermectin within 30 days prior to screening.
• Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
• Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
• History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
• Current use of monoclonal antibodies for the treatment of COVID-19.

Sponsors & Collaborators

• MedinCell S.A: lead
• Violaine Desort-Hénin, DVM: collaborator

Study Sites (1)

Medical Center Medic Ltd.

Sofia, Bulgaria

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; 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: Head of Clinical Development
• Organization: MedinCell

caroline.denot@medincell.com

6 40 38 93 83

Study Officials

• Anna Kostova, MD

  Medical Center Medic Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: March 31, 2022
• Study Start: March 25, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 13, 2022
• Last Updated: December 31, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Locations

BU (1)