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

NCT04374032 | Completed Phase 2 DMC

• 1 other identifier: EN-COVCS-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  21 day

Secondary Outcomes (4)

• Length of in-hospital stay

  21 day

• Survival rate

  21 day

• Intubation rate

  21 day

• Proinflammatory markers levels

  21 day

Study Arms (2)

ENKORTEN

EXPERIMENTAL

Drug: metenkefalin + tridecactide

The standard of care treatment

OTHER

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

Drug: The standard of care

Interventions

metenkefalin + tridecactide DRUG

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

ENKORTEN

The standard of care 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

The standard of care treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bosnalijek D.D: lead

Study Sites (5)

Clinical Center University of Sarajevo

Sarajevo, Sarajevo Canton, 71000, Bosnia and Herzegovina

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Clinical Hospital Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Hospital Travnik

Travnik, 72270, Bosnia and Herzegovina

Location

Cantonal Hospital Zenica

Zenica, 72000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

COVID-19

Interventions

Enkephalin, Methionine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Enkephalins; Opioid Peptides; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Rusmir Baljić, PhD

  Clinical Center University of Sarajevo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: May 1, 2020
• Primary Completion: October 7, 2020
• Study Completion: November 3, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

BO (5)