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.