prophylaxis of covid-19 disease with ivermectin in covid-19 contact persons [german: prophylaxe der covid-19-erkrankung mit ivermectin bei covid-19 kontaktpersonen]

Conditions: Covid19

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.

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.

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 * recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with systemic immunosuppressive drugs * known or clinically suspected disturbance of the blood-brain-barrier (e.g., abcb-1 (=mdr1) mutation) as well as history of neurotoxic effects by ivermectin or other substrates/inhibitors of the para-glycoprotein (p-gp) * known hypersensitivity/intolerance to the study drug or any of its exicpients, in particular ivermectin, microcrystalline cellulose, pre-agglutinated starch, butyl hydroxyanisole or magnesium stearate * pregnancy or lactation * women of child-bearing potential planning to become pregnant or not using effective mehods of contraception * any other severe disorder, which in the opinion of the investigator would preclude the subject from trial participation * previous or planned (during next 14 days) vaccination with any covid-19 vaccine * recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with ivermectin * recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with drugs with evident or potential benefit in treating covid-19 in alignemnt with rki * apparent unreliability or lack of compliance (e.g., not willing to orally administer the required number of tablets on 2 days or not willing to complete the subject diary during 14 days) * known alcohol or drug abuse * participation in another clinical trial during the last 30 days or planned participation in another clinical trial during the next 30 days * previous participation in this same clinical trial

Keywords: covid-19 post-exposure prophylaxis