NCT05060666

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Infectopharm Arzneimittel GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-09-29
• Last updated: 2021-11-02