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

InfectoPharm

Status and phase

Unknown

Phase 3

Conditions

Covid19

Treatments

Drug: Ivermectin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05060666

2021-002445-15 (EudraCT Number)

PREVENT-COVID

Details and patient eligibility

About

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.

Full 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.

Enrollment

412 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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