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

Bosnalijek

Status and phase

Completed

Phase 3

Phase 2

Conditions

COVID-19 Infection

Treatments

Drug: The standard of care

Drug: metenkefalin + tridecactide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04374032

EN-COVCS-01

Details and patient eligibility

About

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

Full 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 release in patients with more severe COVID19. Several studies have suggested a "cytokine storm" caused by the release of IL-6, IL-1, IL-12 and IL-18 with tumor necrosis factor TNF alpha and other inflammatory mediators. Increased inflammatory response of lung tissue may result in increased gas exchange at the alveolar-capillary level making oxygenation difficult in patients with more severe forms of the disease and the need for mechanical ventilation. In this regard, it is hypothesized that the use of immunomodulatory therapy should have an effect in reducing the lethal outcome, the need for oxygen therapy, and mechanical ventilation.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.