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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

Primary Purpose

COVID-19 Infection

Status

Completed

Phase

Phase 2

Locations

Bosnia and Herzegovina

Study Type

Interventional

Intervention

metenkefalin + tridecactide

The standard of care

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Clinical Center University of Sarajevo
University Clinical Centre of the Republic of Srpska
University Clinical Hospital Mostar
Hospital Travnik
Cantonal Hospital Zenica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ENKORTEN

The standard of care treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Length of in-hospital stay

To monitor the period of patient's hospitalization

Survival rate

To monitor the survival rate during the hospitalization

Intubation rate

To monitor the intubation frequency during the hospitalization

Proinflammatory markers levels

To monitor the levels of proinflammatory markers during the hospitalization (IL-6)

Full Information

NCT ID

NCT04374032

First Posted

April 30, 2020

Last Updated

December 23, 2020

Sponsor

Bosnalijek D.D

1. Study Identification

Unique Protocol Identification Number

NCT04374032

Brief Title

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

Official Title

An Open-label, Prospective, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of ENKORTEN® as an Immunomodulatory Therapy, Within the Usual Therapeutically Established Protocol, for the Treatment of Patients With Moderate to Severe COVID-19 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

October 7, 2020 (Actual)

Study Completion Date

November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bosnalijek D.D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ENKORTEN

Arm Type

Experimental

Arm Title

The standard of care treatment

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

metenkefalin + tridecactide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

The standard of care

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to onset of change in the patient's clinical condition

Description

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

Title

Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE

Description

Time Frame

21 day

Secondary Outcome Measure Information:

Title

Length of in-hospital stay

Description

To monitor the period of patient's hospitalization

Time Frame

21 day

Title

Survival rate

Description

To monitor the survival rate during the hospitalization

Time Frame

21 day

Title

Intubation rate

Description

To monitor the intubation frequency during the hospitalization

Time Frame

21 day

Title

Proinflammatory markers levels

Description

To monitor the levels of proinflammatory markers during the hospitalization (IL-6)

Time Frame

21 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rusmir Baljić, PhD

Organizational Affiliation

Clinical Center University of Sarajevo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Center University of Sarajevo

City

Sarajevo

State/Province

Sarajevo Canton

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

University Clinical Centre of the Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

University Clinical Hospital Mostar

City

Mostar

ZIP/Postal Code

88000

Country

Bosnia and Herzegovina

Facility Name

Hospital Travnik

City

Travnik

ZIP/Postal Code

72270

Country

Bosnia and Herzegovina

Facility Name

Cantonal Hospital Zenica

City

Zenica

ZIP/Postal Code

72000

Country

Bosnia and Herzegovina

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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