IMUNOR® preparation in the prevention of COVID-19

Phase 1

• Conditions: COVID-19 prevention; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005524-11-CZ
• Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-01
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- male/female/all sexes
- 18-65 years of age
- ability to sign the Informed Consent Form
- negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- use of another immunomodulation treatment in the course of one month prior to enrolment into the study
- patients with current, insufficiently controlled cardiac, metabolic, endocrinology, hepatal, renal, neurological or psychiatric disease
- known hypersensitivity to the medicinal substance
- pregnancy and breasfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the preventive effect of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Secondary Objective: To evaluate the efficacy of preventive administration of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Primary end point(s): Evaluation of the number of patients with clinical manifestations corresponding with the SARS-Cov-2 infection;Timepoint(s) of evaluation of this end point: The study subjects will be followed for the period of four weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Semiquantitative evaluation of individual clinical parameters using the monitoring of daily symptom score in subjects with preventive administration of IMUNOR;Timepoint(s) of evaluation of this end point: The study subjects will be followed for the period of four weeks.