Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Bosnalijek D.D
Send
Updated on 5 August 2020
See if I qualify
fever
dyspnea
pneumonia
cough
covid-19

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

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.

Details
Condition COVID-19 Infection
Age 18years - 100years
Treatment metenkefalin + tridecactide, The standard of care
Clinical Study IdentifierNCT04374032
SponsorBosnalijek D.D
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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 36.6C axillary route, 37.2C oral route or 37.8 C rectal route), dyspnea, cough and 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

fever
dyspnea
pneumonia
cough
covid-19

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.