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
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.
Drug: metenkefalin + tridecactide
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
Drug: The standard of care
The usual therapeutically established protocol, for the treatment of patients with moderate to severe COVID-19 infection prescribed by The Agency for medicinal products and medical devices of Bosnia and Herzegovina
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.
Clinical Center University of Sarajevo
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina
Hospital Travnik
Travnik, Bosnia and Herzegovina
Cantonal Hospital Zenica
Zenica, Bosnia and Herzegovina
Rusmir Baljić, PhD, Principal Investigator
Clinical Center University of Sarajevo