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

NCT04627233 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-13

No results posted yet for this 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.

Conditions

  • Covid19
  • Treatment
  • Corona Virus Infection

Interventions

DRUG

Human Ezrin Peptide 1 (HEP1)

HEP-1 will be administrated s.c. into the lower abdominal wall 1. induction dosage: 2 mg Ezrin in 2 ml physiological saline applied s.c.,one injection every 12 hours until symptoms disappear followed by 2. maintenance dosage: 0.2 mg Ezrin in 1 ml physiological saline solution s.c 1/day for 10 days

DRUG

Placebo

placebo group received normal saline in a same volume to match corresponding HEP-1 doses. Study drug was administered by qualified staff in research clinic settings; injections were given to abdominal sites on rotating basis, by anatomic quadrant.

Sponsors & Collaborators

  • praxisgemeinschaft für zelltherapie

    collaborator UNKNOWN

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-20
Primary Completion
2021-03-01
Completion
2021-04-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627233 on ClinicalTrials.gov