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

NCT ID: NCT04374032

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-11-03

Brief 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

Detailed 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.

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ENKORTEN

Group Type: EXPERIMENTAL

metenkefalin + tridecactide

Intervention Type: DRUG

ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection

The standard of care treatment

The usual therapeutically established protocol for the treatment of patients with moderate to severe COVID-19 infection

Group Type: OTHER

The standard of care

Intervention Type: DRUG

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

Interventions

metenkefalin + tridecactide

ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bosnalijek D.D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rusmir Baljić, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Center University of Sarajevo

Locations

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

Countries

Bosnia and Herzegovina

Other Identifiers

EN-COVCS-01

Identifier Type: -

Identifier Source: org_study_id