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]

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.

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