Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Last updated: November 11, 2020
Sponsor: Shahid Beheshti University of Medical Sciences
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04627233
IR.SBMU.REC.1399.023
  • Ages 18-70
  • All Genders

Study Summary

Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C.

In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients hospitalized with a positive SARS-CoV-2 PCR test and presenting with one ormore clear clinical symptoms of COVID-19 disease
  • No contraindication to HEP-1
  • Obtained informed consent

Exclusion

Exclusion Criteria:

  • Patients who had received any immuno-modulator therapy
  • Active or chronic kidney/ liver diseases,
  • Oncological diseases
  • Other viral infection including HIV and hepatitis.
  • Any allergic reaction or sensitivity to HEP-1
  • Breast feeding or pregnancy

Study Design

Total Participants: 20
Study Start date:
December 20, 2020
Estimated Completion Date:
April 01, 2021

Connect with a study center

  • Shahid Beheshti University of Medical Sciences

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

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