v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05060666 |
|
Full text link
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
studien@infectopharm.com |
|
Registration date
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
2021-09-29 |
|
Recruitment status
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
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
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Infectopharm Arzneimittel GmbH |
|
Inclusion age min
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
None |
|
Type of patients
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Close contacts to covid patients |
|
Severity scale
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
412 |
|
primary outcome
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
COVID-19 disease |
|
Notes
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |