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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

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ClinicalTrials.gov Identifier: NCT04374032
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bosnalijek D.D

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE May 1, 2020
Actual Primary Completion Date October 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Length of in-hospital stay [ Time Frame: 21 day ]
    To monitor the period of patient's hospitalization
  • Survival rate [ Time Frame: 21 day ]
    To monitor the survival rate during the hospitalization
  • Intubation rate [ Time Frame: 21 day ]
    To monitor the intubation frequency during the hospitalization
  • Proinflammatory markers levels [ Time Frame: 21 day ]
    To monitor the levels of proinflammatory markers during the hospitalization (IL-6)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID-19 Infection
Intervention  ICMJE
  • Drug: metenkefalin + tridecactide
    ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
  • 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
Study Arms  ICMJE
  • Experimental: ENKORTEN
    Intervention: Drug: metenkefalin + tridecactide
  • The standard of care treatment
    The usual therapeutically established protocol for the treatment of patients with moderate to severe COVID-19 infection
    Intervention: Drug: The standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 3, 2020
Actual Primary Completion Date October 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bosnia and Herzegovina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04374032
Other Study ID Numbers  ICMJE EN-COVCS-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bosnalijek D.D
Study Sponsor  ICMJE Bosnalijek D.D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rusmir Baljić, PhD Clinical Center University of Sarajevo
PRS Account Bosnalijek D.D
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP