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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04627233

Collaborator

praxisgemeinschaft für zelltherapie (Other)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Treatment Corona Virus Infection	Drug: Human Ezrin Peptide 1 (HEP1) Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Anticipated Study Start Date :

Dec 20, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: No intervention:control group	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.
Experimental: Experimental:Intervention group	Drug: Human Ezrin Peptide 1 (HEP1) HEP-1 will be administrated s.c. into the lower abdominal wall induction dosage: 2 mg Ezrin in 2 ml physiological saline applied s.c.,one injection every 12 hours until symptoms disappear followed by maintenance dosage: 0.2 mg Ezrin in 1 ml physiological saline solution s.c 1/day for 10 days

Arm

Intervention/Treatment

Placebo Comparator: No intervention:control group

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.

Experimental: Experimental:Intervention group

Drug: Human Ezrin Peptide 1 (HEP1)

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

Outcome Measures

Primary Outcome Measures

Time to clinical improvement of disease symptoms [7 days]
Duration of Hospitalization [28 days]
Duration of artificial ventilation [28 days]

Secondary Outcome Measures

CT Severity score [28 days]
Range 0-40
CBC [28 days]
IL-1 [28 days]
IL-6 [28 days]
TNF [28 days]
CRP [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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