Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 covid19
Started Dec 2020
Shorter than P25 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
December 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedNovember 13, 2020
November 1, 2020
2 months
November 6, 2020
November 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time to clinical improvement of disease symptoms
7 days
Duration of Hospitalization
28 days
Duration of artificial ventilation
28 days
Secondary Outcomes (6)
CT Severity score
28 days
CBC
28 days
IL-1
28 days
IL-6
28 days
TNF
28 days
- +1 more secondary outcomes
Study Arms (2)
No intervention:control group
PLACEBO COMPARATORExperimental:Intervention group
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid Beheshti University of Medical Sciences
Tehran, Iran
Related Publications (4)
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.
PMID: 9365271BACKGROUNDPore 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.
PMID: 25746045BACKGROUNDPore 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.
PMID: 24043890BACKGROUNDMillet 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.
PMID: 23185364BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 13, 2020
Study Start
December 20, 2020
Primary Completion
March 1, 2021
Study Completion
April 1, 2021
Last Updated
November 13, 2020
Record last verified: 2020-11