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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
412
2 doses of Ivermectin will be administered with 48 hours time interval. The dosage is based on body weight calculated as follows: * 15 mg for 40-60 kg = 5 tablets à 3 mg * 18 mg for 60-80 kg = 6 tablets à 3 mg * 24 mg for \> 80 kg = 8 tablets à 3 mg each This corresponds to an ivermectin dose of about 300 µg / kg.
An analogous number of tablets is administered for placebo: * 5 tablets for 40-60 kg * 6 tablets for 60-80 kg * 8 tablets for \> 80 kg The size, appearance, smell and taste of the tablets of placebo are identical to Ivermectin.
COVID-19 disease
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)
Time frame: Day 14
Adverse events and side effects
Number and severity of adverse events and side effects.
Time frame: 14 days
Type, number and severity of symptoms
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)
Time frame: 14 days
Severity of the COVID-19 disease
Severity of the COVID-19 disease according to the investigator's assessment
Time frame: 14 days
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