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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627233
Recruitment Status : Not yet recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
praxisgemeinschaft für zelltherapie
Information provided by (Responsible Party):
Shahid Beheshti University of Medical Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Treatment Corona Virus Infection Drug: Human Ezrin Peptide 1 (HEP1) Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
Estimated Study Start Date : December 20, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: No intervention:control group Drug: 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.
Experimental: Experimental:Intervention group Drug: Human Ezrin Peptide 1 (HEP1)

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


Outcome Measures
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Primary Outcome Measures :
  1. Time to clinical improvement of disease symptoms [ Time Frame: 7 days ]
  2. Duration of Hospitalization [ Time Frame: 28 days ]
  3. Duration of artificial ventilation [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. CT Severity score [ Time Frame: 28 days ]
    Range 0-40

  2. CBC [ Time Frame: 28 days ]
  3. IL-1 [ Time Frame: 28 days ]
  4. IL-6 [ Time Frame: 28 days ]
  5. TNF [ Time Frame: 28 days ]
  6. CRP [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627233


Locations
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Iran, Islamic Republic of
Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Contact: Farzad Ashrafi       farzad.ashrafi@sbmu.ac.ir   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
praxisgemeinschaft für zelltherapie
More Information
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Publications:

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Responsible Party: Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04627233    
Other Study ID Numbers: IR.SBMU.REC.1399.023
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shahid Beheshti University of Medical Sciences:
COVID19
Treatment
Ezrin peptide
HEP-1
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases