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

NCT ID: NCT04627233

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-20
• Study Completion Date: 2021-04-01

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.

Conditions

Covid19; Treatment; Corona Virus Infection

Keywords

COVID19; Treatment; Ezrin peptide; HEP-1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

No intervention:control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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:Intervention group

Group Type: EXPERIMENTAL

Human Ezrin Peptide 1 (HEP1)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

praxisgemeinschaft für zelltherapie

UNKNOWN

Sponsor Role: collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shahid Beheshti University of Medical Sciences

Tehran, , Iran

Countries

Iran

Facility Contacts

Farzad Ashrafi

Role: primary

References

Bretscher A, Reczek D, Berryman M. Ezrin: a protein requiring conformational activation to link microfilaments to the plasma membrane in the assembly of cell surface structures. J Cell Sci. 1997 Dec;110 ( Pt 24):3011-8. doi: 10.1242/jcs.110.24.3011.

Reference Type: BACKGROUND

PMID: 9365271 (View on PubMed)

Pore D, Gupta N. The ezrin-radixin-moesin family of proteins in the regulation of B-cell immune response. Crit Rev Immunol. 2015;35(1):15-31. doi: 10.1615/critrevimmunol.2015012327.

Reference Type: BACKGROUND

PMID: 25746045 (View on PubMed)

Pore D, Parameswaran N, Matsui K, Stone MB, Saotome I, McClatchey AI, Veatch SL, Gupta N. Ezrin tunes the magnitude of humoral immunity. J Immunol. 2013 Oct 15;191(8):4048-58. doi: 10.4049/jimmunol.1301315. Epub 2013 Sep 16.

Reference Type: BACKGROUND

PMID: 24043890 (View on PubMed)

Millet JK, Kien F, Cheung CY, Siu YL, Chan WL, Li H, Leung HL, Jaume M, Bruzzone R, Peiris JS, Altmeyer RM, Nal B. Ezrin interacts with the SARS coronavirus Spike protein and restrains infection at the entry stage. PLoS One. 2012;7(11):e49566. doi: 10.1371/journal.pone.0049566. Epub 2012 Nov 21.

Reference Type: BACKGROUND

PMID: 23185364 (View on PubMed)

Other Identifiers

IR.SBMU.REC.1399.023

Identifier Type: -

Identifier Source: org_study_id