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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
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
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
Time to onset of change in the patient's clinical condition
The time of onset of improvement in the patient's clinical condition will be measured following the clinical objective and subjective signs and radiological indicators.
Time frame: 21 day
Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE
At every examination/evaluation, all AEs, whether noticed by investigators and their associates in the trial, or spontaneously reported by the subjects, or given as answer to direct question, must be evaluated by the investigator and reported on case report forms for AE. AE will be recorded in the e-CRF. Three-degree scale will be used for assessment of AE's severity: mild, moderate, severe.
Time frame: 21 day
Length of in-hospital stay
To monitor the period of patient's hospitalization
Time frame: 21 day
Survival rate
To monitor the survival rate during the hospitalization
Time frame: 21 day
Intubation rate
To monitor the intubation frequency during the hospitalization
Time frame: 21 day
Proinflammatory markers levels
To monitor the levels of proinflammatory markers during the hospitalization (IL-6)
Time frame: 21 day
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Cantonal Hospital Zenica
Zenica, Bosnia and Herzegovina