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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374032
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Bosnalijek D.D

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

Condition or disease Intervention/treatment Phase
COVID-19 Infection Drug: metenkefalin + tridecactide Drug: The standard of care Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: ENKORTEN Drug: metenkefalin + tridecactide
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
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




Primary Outcome Measures :
  1. Time to onset of change in the patient's clinical condition [ Time Frame: 21 day ]
    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.

  2. Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE [ Time Frame: 21 day ]
    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 :
  1. Length of in-hospital stay [ Time Frame: 21 day ]
    To monitor the period of patient's hospitalization

  2. Survival rate [ Time Frame: 21 day ]
    To monitor the survival rate during the hospitalization

  3. Intubation rate [ Time Frame: 21 day ]
    To monitor the intubation frequency during the hospitalization

  4. Proinflammatory markers levels [ Time Frame: 21 day ]
    To monitor the levels of proinflammatory markers during the hospitalization (IL-6)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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), 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374032


Contacts
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Contact: Jasna Dzananovic, MPharm +38733560603 Jasna.Dzananovic@Bosnalijek.com

Locations
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Bosnia and Herzegovina
Clinical Center University of Sarajevo Recruiting
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina, 71000
Contact: Rusmir Baljic, doc.dr.med         
Sponsors and Collaborators
Bosnalijek D.D
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Responsible Party: Bosnalijek D.D
ClinicalTrials.gov Identifier: NCT04374032    
Other Study ID Numbers: EN-COVCS-01
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases