Clinical trial NCT05060666: Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]
Official title: 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]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Keywords: COVID-19 post-exposure prophylaxis
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: GKM Gesellschaft für Therapieforschung mbH
First posted: 2021-09-29
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: COVID-19 disease
timeFrame: Day 14
Secondary outcomes:
measure: Adverse events and side effects
timeFrame: 14 days
measure: Type, number and severity of symptoms
timeFrame: 14 days
measure: Severity of the COVID-19 disease
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References: