Covid19Phase 3NCT05060666
Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]
A Phase 3 study testing Ivermectin in people with Covid19, run by Infectopharm Arzneimittel GmbH.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of at least 18 years
- adult subject living in the same household as a related COVID-19 patient (index person)
Who cannot join
- 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
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- 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
About this study
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]
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Ivermectin, Placebo
- Keywords
- COVID-19 post-exposure prophylaxis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Driponin, ATC-code P02CF01, Substance code SUB12089MIG
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | 2 doses of ivermectin at day 0 and day 2 Receives: Drug: Ivermectin |
| Placebo | Placebo comparator | 2 doses of placebo at day 0 and day 2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 14
Secondary outcomes (3)
Adverse events and side effects
Number and severity of adverse events and side effects.
Measured: 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)
Measured: 14 days
Severity of the COVID-19 disease
Severity of the COVID-19 disease according to the investigator's assessment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startNov 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infectopharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060666
- Sponsor's protocol ID
- PREVENT-COVID
- Other IDs
- 2021-002445-15
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT05060666
- Acronym / sponsor ID
- PREVENT-COVID
- Conditions
- Covid19
- Keywords
- COVID-19 post-exposure prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- Nov 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: Ivermectin2 doses of ivermectin at day 0 and day 2 |
| Placebo | Placebo comparator | Drug: Placebo2 doses of placebo at day 0 and day 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age of at least 18 years
- adult subject living in the same household as a related COVID-19 patient (index person)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinAlso: Driponin, ATC-code P02CF01, Substance code SUB12089MIG2 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. | Drug | Ivermectin |
| PlaceboAn 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. | Drug | Placebo |
Primary outcome
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)
3 secondary outcomes
Adverse events and side effects
Time frame: 14 days
Type, number and severity of symptoms
Time frame: 14 days
Severity of the COVID-19 disease
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin in people with Covid19, run by Infectopharm Arzneimittel GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 disease (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.