COVID-19 InfectionPhase 2/3NCT04374032
Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection
A Phase 2/3 study testing metenkefalin + tridecactide in people with COVID-19 Infection, run by Bosnalijek D.D at 5 sites in Bosnia and Herzegovina.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- metenkefalin + tridecactide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesBosnia and Herzegovina
- Study dates
- 1 May 2020to 3 Nov 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Bosnia and Herzegovina5 sites
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000
University Clinical Hospital Mostar
Mostar, 88000
Clinical Center University of Sarajevo
Sarajevo, Sarajevo Canton, 71000
Hospital Travnik
Travnik, 72270
Cantonal Hospital Zenica
Zenica, 72000
About this study
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
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
Read the 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.
- Conditions
- COVID-19 Infection
- Being tested
- metenkefalin + tridecactide, The standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metenkefalin + tridecactideDrug
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
The standard of careDrug
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 group | Role | What they receive |
|---|---|---|
| ENKORTEN | Experimental | Not described Receives: 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 Receives: Drug: The standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21 day
Secondary outcomes (4)
Length of in-hospital stay
To monitor the period of patient's hospitalization
Measured: 21 day
Survival rate
To monitor the survival rate during the hospitalization
Measured: 21 day
Intubation rate
To monitor the intubation frequency during the hospitalization
Measured: 21 day
Proinflammatory markers levels
To monitor the levels of proinflammatory markers during the hospitalization (IL-6)
Measured: 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 May 2020
- Primary completion7 Oct 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bosnalijek D.D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rusmir Baljić, PhD, Principal investigator, Clinical Center University of Sarajevo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374032
- Sponsor's protocol ID
- EN-COVCS-01
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04374032
- Acronym / sponsor ID
- EN-COVCS-01
- Conditions
- COVID-19 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bosnalijek D.DIndustry (pharma, biotech, devices)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment
| Arm | Type | Receives |
|---|---|---|
| ENKORTEN | Experimental | Drug: metenkefalin + tridecactide |
| The standard of care treatment | Other | Drug: The standard of careThe usual therapeutically established protocol for the treatment of patients with moderate to severe COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metenkefalin + tridecactideENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection | Drug | ENKORTEN |
| The standard of careThe 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 | Drug | The standard of care treatment |
Primary outcome
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.
4 secondary outcomes
Length of in-hospital stay
Time frame: 21 day
Survival rate
Time frame: 21 day
Intubation rate
Time frame: 21 day
Proinflammatory markers levels
Time frame: 21 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rusmir Baljić, PhD principal investigator
Clinical Center University of Sarajevo
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing metenkefalin + tridecactide in people with COVID-19 Infection, run by Bosnalijek D.D at 5 sites in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of change in the patient's clinical condition (time frame: 21 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.