Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]
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|ClinicalTrials.gov Identifier: NCT05060666|
Recruitment Status : Not yet recruiting
First Posted : September 29, 2021
Last Update Posted : November 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Ivermectin Drug: Placebo||Phase 3|
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
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)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||412 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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]|
|Estimated Study Start Date :||November 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
2 doses of ivermectin at day 0 and day 2
2 doses of Ivermectin will be administered with 48 hours time interval.
The dosage is based on body weight calculated as follows:
This corresponds to an ivermectin dose of about 300 µg / kg.
Placebo Comparator: Placebo
2 doses of placebo at day 0 and day 2
An analogous number of tablets is administered for placebo:
The size, appearance, smell and taste of the tablets of placebo are identical to Ivermectin.
- COVID-19 disease [ Time Frame: Day 14 ]Occurrence of a COVID-19 disease up to the final visit (day 14), defined as the presence of the clinical condition according to the RKI case definition (acute respiratory symptoms of any severity OR new loss of smell and taste occurred OR illness-related death) AND a positive SARS-CoV-2 PCR test on the day the symptoms were determined (+/- 4 days)
- Adverse events and side effects [ Time Frame: 14 days ]Number and severity of adverse events and side effects.
- Type, number and severity of symptoms [ Time Frame: 14 days ]Type, number and severity of symptoms within the 14-day of study on subjects suffering from COVID-19 (incl. hospitalization, oxygen saturation and demand, intensive care treatment)
- Severity of the COVID-19 disease [ Time Frame: 14 days ]Severity of the COVID-19 disease according to the investigator's assessment