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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19, Treatment, Corona Virus Infection

Intervention / Treatment
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* Drug: Human Ezrin Peptide 1 (HEP1)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No intervention:control group<br> | Drug: Placebo<br>* 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.<br>|
| Experimental: Experimental:Intervention group<br> | Drug: Human Ezrin Peptide 1 (HEP1)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement of disease symptoms |  | 7 days | 
| Duration of Hospitalization |  | 28 days | 
| Duration of artificial ventilation |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT Severity score | Range 0-40 | 28 days | 
| CBC |  | 28 days | 
| IL-1 |  | 28 days | 
| IL-6 |  | 28 days | 
| TNF |  | 28 days | 
| CRP |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Treatment, Ezrin peptide, HEP-1