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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 Infection | Drug: metenkefalin + tridecactide Drug: The standard of care | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | October 7, 2020 |
Actual Study Completion Date : | November 3, 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
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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 |
- 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.
- 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)

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

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
Bosnia and Herzegovina | |
Clinical Center University of Sarajevo | |
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina, 71000 | |
University Clinical Centre of the Republic of Srpska | |
Banja Luka, Bosnia and Herzegovina, 78000 | |
University Clinical Hospital Mostar | |
Mostar, Bosnia and Herzegovina, 88000 | |
Hospital Travnik | |
Travnik, Bosnia and Herzegovina, 72270 | |
Cantonal Hospital Zenica | |
Zenica, Bosnia and Herzegovina, 72000 |
Principal Investigator: | Rusmir Baljić, PhD | Clinical Center University of Sarajevo |
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: | December 24, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases COVID-19 Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Enkephalin, Methionine Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |