Clinical trial NCT04374032: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19 Infection
Lead sponsor: Bosnalijek D.D
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment
Primary purpose: TREATMENT

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.

Eligibility 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), 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.

Primary outcomes:
measure: Time to onset of change in the patient's clinical condition
timeFrame: 21 day
measure: Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE
timeFrame: 21 day
Secondary outcomes:
measure: Length of in-hospital stay
timeFrame: 21 day
measure: Survival rate
timeFrame: 21 day
measure: Intubation rate
timeFrame: 21 day
measure: Proinflammatory markers levels
timeFrame: 21 day
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
state: Sarajevo Canton
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Travnik
country: Bosnia and Herzegovina
facility: Hospital Travnik
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal Hospital Zenica
Study officials:
affiliation: Clinical Center University of Sarajevo
name: Rusmir Baljić, PhD
role: PRINCIPAL_INVESTIGATOR
References: