Overview

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

Status:
Not yet recruiting
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Collaborator:
praxisgemeinschaft für zelltherapie
Criteria
Inclusion Criteria:

- Patients hospitalized with a positive SARS-CoV-2 PCR test and presenting with one or
more clear clinical symptoms of COVID-19 disease

- No contraindication to HEP-1

- Obtained informed consent

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