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

Covid19 Clinical Trial

Official title:

The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04627233
• Other study ID #: IR.SBMU.REC.1399.023
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 20, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Covid19
• Infection
• Severe Acute Respiratory Syndrome
• Treatment

Intervention

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
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences	praxisgemeinschaft für zelltherapie

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical improvement of disease symptoms		7 days
Primary	Duration of Hospitalization		28 days
Primary	Duration of artificial ventilation		28 days
Secondary	CT Severity score	Range 0-40	28 days
Secondary	CBC		28 days
Secondary	IL-1		28 days
Secondary	IL-6		28 days
Secondary	TNF		28 days
Secondary	CRP		28 days