Clinical trial NCT04627233: Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
Official title: The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
Treatment
Corona Virus Infection
Keywords: COVID19
Treatment
Ezrin peptide
HEP-1
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: praxisgemeinschaft für zelltherapie
First posted: 2020-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to clinical improvement of disease symptoms
timeFrame: 7 days
measure: Duration of Hospitalization
timeFrame: 28 days
measure: Duration of artificial ventilation
timeFrame: 28 days
Secondary outcomes:
measure: CT Severity score
timeFrame: 28 days
measure: CBC
timeFrame: 28 days
measure: IL-1
timeFrame: 28 days
measure: IL-6
timeFrame: 28 days
measure: TNF
timeFrame: 28 days
measure: CRP
timeFrame: 28 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Sciences
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.