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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Infectopharm Arzneimittel GmbH
• Collaborator: GKM Gesellschaft für Therapieforschung mbH
• Treatments: Ivermectin

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