Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection
Lead Sponsor:
Bosnalijek D.D
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection
Detailed Description
The justification for the use of immunomodulatory therapy is based on the evidence that drugs that are inhibitors of interleukin IL6 may prevent the more severe lung tissue damage caused by cytokine r...
Eligibility Criteria
Inclusion
- Patients with laboratory-confirmed (PCR) COVID-19 infection
- Patients with moderate to severe COVID-19 infection
- Hospitalized patients on clinical centers and cantonal hospitals
- Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity
- Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above ≥ 36.6⁰C axillary route, ≥ 37.2°C oral route or ≥ 37.8 °C rectal route), and/or dyspnea, and/or cough, and/or SpO2 \<96%
- Patients aged above 18, both genders
- Patients able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness
Exclusion
- Patients not COVID-19 positive
- Patients with mild COVID-19 infection
- Patients who are study subjects in another clinical study for another investigational agent for COVID-19
- Patients with malignant hypertension
- Patients with malignant disease and who are treated for malignant diseases in the last 5 years
- Patients with severe liver and kidney insufficiency
- Patients who are receiving therapy with an immunomodulatory or immunosuppressive agent
- Patients aged below 18, female patients who are pregnant or breastfeeding
- Known allergy to study drug or any component thereof
- Use of haloperidol, dopamine antagonists, or nonsteroidal anti-inflammatory drugs, except paracetamol.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04374032
Start Date
May 1 2020
End Date
November 3 2020
Last Update
December 24 2020
Active Locations (5)
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1
Clinical Center University of Sarajevo
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina, 71000
2
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
3
University Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 88000
4
Hospital Travnik
Travnik, Bosnia and Herzegovina, 72270