Scientific Name: HEP-1 (Ezrin Peptide)
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
Study Description of HEP-1 (Ezrin Peptide)
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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
Arms and Interventions
|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
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 ]
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|
- 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
- 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
Iran, Islamic Republic of
|Shahid Beheshti University of Medical Sciences|
|Tehran, Iran, Islamic Republic of|
|Contact: Farzad Ashrafi email@example.com|
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
praxisgemeinschaft für zelltherapie
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, 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.
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