Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]
Primary Purpose
Covid19
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring COVID-19 post-exposure prophylaxis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ivermectin
Placebo
Arm Description
2 doses of ivermectin at day 0 and day 2
2 doses of placebo at day 0 and day 2
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Adverse events and side effects
Number and severity of adverse events and side effects.
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)
Severity of the COVID-19 disease
Severity of the COVID-19 disease according to the investigator's assessment
Full Information
NCT ID
NCT05060666
First Posted
September 28, 2021
Last Updated
November 1, 2021
Sponsor
Infectopharm Arzneimittel GmbH
Collaborators
GKM Gesellschaft für Therapieforschung mbH
1. Study Identification
Unique Protocol Identification Number
NCT05060666
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infectopharm Arzneimittel GmbH
Collaborators
GKM Gesellschaft für Therapieforschung mbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19 post-exposure prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin
Arm Type
Experimental
Arm Description
2 doses of ivermectin at day 0 and day 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 doses of placebo at day 0 and day 2
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Driponin, ATC-code P02CF01, Substance code SUB12089MIG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19 disease
Description
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
Secondary Outcome Measure Information:
Title
Adverse events and side effects
Description
Number and severity of adverse events and side effects.
Time Frame
14 days
Title
Type, number and severity of symptoms
Description
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
Title
Severity of the COVID-19 disease
Description
Severity of the COVID-19 disease according to the investigator's assessment
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
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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