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Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]

NCT05060666 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2021-11-02

No results posted yet for this study

Summary

The Prevent-COVID study is a prospective, multicenter, randomized, two-armed, placebo-controlled, double-blind, interventional study in which the efficacy and safety of ivermectin in COVID-19 post-exposure prophylaxis (PEP) is examined in adult, close family contacts living in the household of a subject suffering from COVID-19.

Conditions

  • Covid19

Interventions

DRUG

Ivermectin

2 doses of Ivermectin will be administered with 48 hours time interval. The dosage is based on body weight calculated as follows: * 15 mg for 40-60 kg = 5 tablets à 3 mg * 18 mg for 60-80 kg = 6 tablets à 3 mg * 24 mg for \> 80 kg = 8 tablets à 3 mg each This corresponds to an ivermectin dose of about 300 µg / kg.

DRUG

Placebo

An analogous number of tablets is administered for placebo: * 5 tablets for 40-60 kg * 6 tablets for 60-80 kg * 8 tablets for \> 80 kg The size, appearance, smell and taste of the tablets of placebo are identical to Ivermectin.

Sponsors & Collaborators

  • GKM Gesellschaft für Therapieforschung mbH

    collaborator UNKNOWN

  • Infectopharm Arzneimittel GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-03-31
Completion
2022-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060666 on ClinicalTrials.gov