A Phase 2/3 interventional study of metenkefalin + tridecactide and The standard of care in COVID-19 Infection, sponsored by Bosnalijek D.D. Completed at 5 sites in Bosnia and Herzegovina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Bosnalijek D.D · Phase 2/3, Interventional, and Treatment
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
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 120 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Bosnalijek D.D is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: metenkefalin + tridecactide
The usual therapeutically established protocol for the treatment of patients with moderate to severe COVID-19 infection
Drug: The standard of care
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
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
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.
Time frame: 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.
Time frame: 21 day
Length of in-hospital stay
To monitor the period of patient's hospitalization
Time frame: 21 day
Survival rate
To monitor the survival rate during the hospitalization
Time frame: 21 day
Intubation rate
To monitor the intubation frequency during the hospitalization
Time frame: 21 day
Proinflammatory markers levels
To monitor the levels of proinflammatory markers during the hospitalization (IL-6)
Time frame: 21 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Bosnalijek D.D