Name: HEP-1 (Ezrin Peptide) Nasal Spray
SKU: d1e6483e494a-1-2-1-3-1-1-1
Price: 825.00 ZAR
Availability: InStock

Scientific Name: HEP-1 (Ezrin Peptide) Nasal Spray
Clinical Test Expectation: COVID-19 relief and potential COVID-19 cure as per studies shown in product description
MG Strength: 10 mg per vial

Detailed Product Information

Result info for HEP-1 (Ezrin Peptide) Nasal Spray

Study Description of HEP-1 (Ezrin Peptide) Nasal Spray

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
Covid19TreatmentCorona Virus Infection	Drug: Human Ezrin Peptide 1 (HEP1)Drug: Placebo	Phase 1

Study Design

Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Study Start Date :	December 20, 2020
Estimated Primary Completion Date :	March 1, 2021
Estimated Study Completion Date :	April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronavirus Infections

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627233

Locations Iran, Islamic Republic of
Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Contact: Farzad Ashrafi farzad.ashrafi@sbmu.ac.ir

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

praxisgemeinschaft für zelltherapie

More Information

Publications:

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. Review.

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. Review.

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.

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.

Mixing and our recommended dosage

TBA

Additional Information