Overview

Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection

Status:
Completed
Trial end date:
2020-11-03
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bosnalijek D.D
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.