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Covid19Phase 1NCT04627233

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

A Phase 1 study testing Human Ezrin Peptide 1 (HEP1) in people with Covid19 and Treatment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Covid19, Treatment, Corona Virus Infection
What is being tested?
Human Ezrin Peptide 1 (HEP1)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteIran
Study dates
20 Dec 2020to 1 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Iran1 site

  • Shahid Beheshti University of Medical Sciences

    Tehran

    Farzad Ashrafi, farzad.ashrafi@sbmu.ac.ir

Other trials in Iran

About this study

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

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.

Being tested
Human Ezrin Peptide 1 (HEP1), Placebo
Keywords
COVID19, Treatment, Ezrin peptide, HEP-1
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Ezrin Peptide 1 (HEP1)Drug

    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

  • PlaceboDrug

    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.

Study groups in NCT04627233
Study groupRoleWhat they receive
No intervention:control groupPlacebo comparatorNot described
Receives: Drug: Placebo
Experimental:Intervention groupExperimentalNot described
Receives: Drug: Human Ezrin Peptide 1 (HEP1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to clinical improvement of disease symptoms

    Measured: 7 days

  2. Duration of Hospitalization

    Measured: 28 days

  3. Duration of artificial ventilation

    Measured: 28 days

Secondary outcomes (6)

  1. CT Severity score

    Range 0-40

    Measured: 28 days

  2. CBC

    Measured: 28 days

  3. IL-1

    Measured: 28 days

  4. IL-6

    Measured: 28 days

  5. TNF

    Measured: 28 days

  6. CRP

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start20 Dec 2020 (estimated)
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627233
Sponsor's protocol ID
IR.SBMU.REC.1399.023
Status last verified
Nov 2020
First submitted
6 Nov 2020
Last updated
13 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 9365271

  • 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.

    PubMed 25746045

  • 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.

    PubMed 24043890

  • 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.

    PubMed 23185364

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human Ezrin Peptide 1 (HEP1) in people with Covid19 and Treatment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to clinical improvement of disease symptoms (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627233, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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