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

Phase 1

• Conditions: Corona Virus Infection; Covid19; Treatment
• Interventions: Drug: Placebo; Drug: Human Ezrin Peptide 1 (HEP1)

• Registration Number: NCT04627233
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13
• Study Start: 2020-12-20
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No intervention:control group	Placebo	-
Experimental:Intervention group	Human Ezrin Peptide 1 (HEP1)	-

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement of disease symptoms	7 days
Duration of artificial ventilation	28 days
Duration of Hospitalization	28 days

Secondary Outcome Measures

Name	Time	Method
IL-6	28 days
CT Severity score	28 days	Range 0-40
TNF	28 days
CRP	28 days
IL-1	28 days
CBC	28 days

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of