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]
Overview
- Phase
- Phase 3
- Intervention
- Ivermectin
- Conditions
- Covid19
- Sponsor
- Infectopharm Arzneimittel GmbH
- Enrollment
- 412
- Primary Endpoint
- COVID-19 disease
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age of at least 18 years
- •adult subject living in the same household as a related COVID-19 patient (index person)
Exclusion Criteria
- •index person has COVID-19 symptoms for more than 5 days at enrolment
- •known past COVID-19 or current infection confirmed by positive SARS-CoV-2 PCR test at enrolment
- •symptoms at enrolment indicating COVID-19: increased body temperature OR acute respiratory symptoms of any severity OR newly occuring loss of taste or smell OR ague OR sumulatneously occuring headache and body ache
- •known contraindications to the use of the study medication (in alignemnt with current summary of product characteristics of Driponin®)
- •known chronic obstructive pulmonary disease
- •known acute or chronic hepatitis B or C or other clinically recognizable or known liver dysfunction
- •known HIV infection or AIDS
- •known symptomatic allergic rhinitis
- •current (inlcuding up to 24 hours before enrolment) or planned (during next 14 days) therapy with non-steroidal anti-inflammatory drugs, other pain medication (e.g., ASS (including prophylactic use), metamizol)
- •recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with systemic steroids
Arms & Interventions
Ivermectin
2 doses of ivermectin at day 0 and day 2
Intervention: Ivermectin
Placebo
2 doses of placebo at day 0 and day 2
Intervention: Placebo
Outcomes
Primary Outcomes
COVID-19 disease
Time Frame: Day 14
Occurrence of a COVID-19 disease up to the final visit (day 14), defined as the presence of the clinical condition according to the RKI case definition (acute respiratory symptoms of any severity OR new loss of smell and taste occurred OR illness-related death) AND a positive SARS-CoV-2 PCR test on the day the symptoms were determined (+/- 4 days)
Secondary Outcomes
- Adverse events and side effects(14 days)
- Type, number and severity of symptoms(14 days)
- Severity of the COVID-19 disease(14 days)