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

COVID-19 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374032
• Other study ID #: EN-COVCS-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2020
• Est. completion date: November 3, 2020

Study information

• Verified date: December 2020
• Source: Bosnalijek D.D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 3, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 = 36.6°C 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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19 Infection
• Infection

Intervention

Drug:
• metenkefalin + tridecactide
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
• 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

Locations

Country	Name	City	State
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	University Clinical Hospital Mostar	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo	Sarajevo	Sarajevo Canton
Bosnia and Herzegovina	Hospital Travnik	Travnik
Bosnia and Herzegovina	Cantonal Hospital Zenica	Zenica

Sponsors (1)

Lead Sponsor	Collaborator
Bosnalijek D.D

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of in-hospital stay	To monitor the period of patient's hospitalization	21 day
Secondary	Survival rate	To monitor the survival rate during the hospitalization	21 day
Secondary	Intubation rate	To monitor the intubation frequency during the hospitalization	21 day
Secondary	Proinflammatory markers levels	To monitor the levels of proinflammatory markers during the hospitalization (IL-6)	21 day