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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Corona Virus Infection; Treatment; Covid19

Treatments: Drug: Placebo; Drug: Human Ezrin Peptide 1 (HEP1)

Study type: Interventional

Funder types: Other

Identifiers

NCT04627233

IR.SBMU.REC.1399.023

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

No intervention:control group

Placebo Comparator group

Treatment:

Drug: Placebo

Experimental:Intervention group

Experimental group

Treatment:

Drug: Human Ezrin Peptide 1 (HEP1)