A randomized, open-label, phase IV monocentric study evaluating the clinical effect of oral immunomodulatory therapy with IMUNOR® in patients with moderate COVID-19 disease
- Conditions
- Patients with COVID -19 diseaseTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002497-27-CZ
- Lead Sponsor
- Thomayerova nemocnice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
• Women or men aged 18 and over;
• Documented incidence of COVID-19 disease with moderate clinical manifestations requiring hospitalization (as assessed by the attending physician);
• The patient's ability to cooperate and sign the informed consent form;
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Use of any other immunomodulatory treatment during the last month before entering the study (bacterial lysates, immunoglucans, immunoglobulins, etc.)
• Need for pulmonary ventilation at study entry;
• Known hypersensitivity to the active substance;
• Pregnancy and breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to verify the potential of a registered drug in the fight against a highly contagious pandemic disease;Secondary Objective: - frequency of worsening of patients into severe disease with the need for supportive lung ventilation;<br>- frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations);<br>- time to normalization of body temperature, CRP, leukocyte count;<br>- length of hospital stay;<br>- rate of virus elimination from HCD secretions;<br>- occurrence of adverse events.<br>- Consumption of ATB prescribed for the treatment of respiratory infections;Primary end point(s): evaluation of the change in symptom score within 2 weeks of starting IMUNOR administration;Timepoint(s) of evaluation of this end point: 2 weeks of starting IMUNOR administration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - frequency of worsening of patients into severe disease with the need for supportive lung ventilation;<br>- frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations);<br>- time to normalization of body temperature, CRP, leukocyte count;<br>- length of hospital stay;<br>- rate of virus elimination from HCD secretions;<br>- occurrence of adverse events.<br>- Consumption of ATB prescribed for the treatment of respiratory infections;Timepoint(s) of evaluation of this end point: weekly, till Day 28