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

Recruiting
participants needed

120
sponsor

Bosnalijek D.D

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Updated on 19 February 2024

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fever

dyspnea

pneumonia

cough

covid-19

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

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.

Details

Condition	COVID-19 Infection
Age	18years - 100years
Treatment	metenkefalin + tridecactide, The standard of care
Clinical Study Identifier	NCT04374032
Sponsor	Bosnalijek D.D
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 36.6C axillary route, 37.2C oral route or 37.8 C rectal route), dyspnea, cough and 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

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