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

Covid19 Clinical Trial

Official title:
Placebo-controlled Randomized Double-blind Phase III Study on the Efficacy and Safety of Ivermectin Tablets (Driponin®) for the Prophylaxis of COVID-19 Disease in Adult Contact Persons Living in the Household of a Person Suffering From COVID-19 [German: Placebo-kontrollierte Randomisierte Doppel-blinde Phase III Studie Zur Wirksamkeit Und Sicherheit Von Ivermectin Tabletten (Driponin®) für Die Prophylaxe Der COVID-19 Erkrankung Bei im Haushalt Lebenden Erwachsenen Kontaktpersonen Einer an COVID-19 Erkrankten Person]

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Study population and study sites: The study is carried out in about 30 private practices or clinics in Germany that regularly carry out SARS-CoV-2 PCR tests and treat COVID-19 patients. Adult close contact persons of newly diagnosed COVID-19 patients living in the same household are considered for participation. Study duration and assessment: The study will last 14 days, in which the following study-specific measures will be undertaken: - Documentation of demographics (age, gender, ethnicity, height and weight, degree of relationship to the COVID-19 patient) - Documentation of current comorbidities - Documentation of current medical accompanying measures - Documentation of the general condition - Vital signs - COVID-19 symptoms - SARS-CoV-2 PCR test: Only for medical confirmation of the presence of COVID-19 symptoms during an unplanned COVID-19 visit or final visit. - Subject diary (daily measurement of body temperature, contact intensity with the index person) - Pregnancy test in women of childbearing potential Objectives: Primary Objective: To demonstrate the efficacy of ivermectin in the COVID-19 post-exposure prophylaxis of adult contact persons living in the household of a person suffering from COVID-19 (index person) Secondary objectives: - To demonstrate the safety of ivermectin in the COVID-19 post-exposure prophylaxis of adult contact persons living in the household of a person suffering from COVID-19 (index person) - To determine the severity of the symptoms of subjects suffering from COVID-19 during the study period and the comparison between the ivermectin and the placebo group. IMP: Driponin® is an approved drug with the active ingredient Ivermectin, used to treat parasitic infections. One tablet Driponin® contains 3 mg Ivermectin. As part of the clinical trial, the medicinal product will be examined with regard to indication, dosage and application schedule deviating from the intended purpose and the package insert. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05060666
Study type	Interventional
Source	Infectopharm Arzneimittel GmbH
Contact
Status	Not yet recruiting
Phase	Phase 3
Start date	November 2021
Completion date	March 2022

View Details

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