Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT05060666
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05060666
Study Brief:
Protocol Section:
NCT05060666