The Human Ezrin Peptid 1 (HEP1) as a therapeutic agent in SARS coV 2 positive patients.

Human Ezrin Peptide 1 (HEP1) as a therapeutic agent for SARS-CoV-2 (COVID 19) positive patients - a randomized controlled clinical trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005527-36-AT

Enrollment

100

Registered

2021-01-18

Start date

2022-08-10

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients admitted to hospital with a SARS CoV 2 infection with fever and other COVID relevant symptoms

Interventions

Product Name: Human Ezrin Peptid 1 (HEP1) Product Code: TEKKRRETVEREKE Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Tetradecapeptide CAS Number: 8000019-76-3 Curren

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • patients hospitalized with a positive SARS-CoV-2 PCR test • fever (> 38°C), checked with a standardised ear thermometer • =5 and = 8 points on the WHO Clinical Progression Scale • signed valid declaration of consent (IC) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: • < 18 years old • Pregnant or breast-feeding woman (checked by HCG test in serum or urine) • History of known hypersensitivity to the study drug or their components • Participation in another clinical trial or taking of another investigational drug • Other comorbidities in which, in the opinion of the investigator, the risks of administration of the study drug is not acceptable • Valid DNR (Do-Not-resuscitate) or DNE (Do- Not Escalate) protocol • Patients, who, in the opinion of the investigator, will not survive the next 7 days

Design outcomes

Primary

Measure	Time frame
Main Objective: Time to clinical improvement of at least 1 point on the WHO Clinical Progression scale ;Secondary Objective: -Clinical improvement of disease symptoms (reduction of temperature <37.5°C) -Time interval to negative SARS-CoV-2 PCR test result -Time interval to changes of cytokine release (IL-6, CRP) -Course of the oxygenation parameters (Horowitz Index) -Duration of hospitalization -Duration of artificial ventilation (if necessary) -Difference in Post covid functional status scale ;Primary end point(s): Time to clinical improvement of at least 1 point on the WHO Clinical Progression scale ;Timepoint(s) of evaluation of this end point: until the symptoms improve	—

Measure

Time frame

Main Objective: Time to clinical improvement of at least 1 point on the WHO Clinical Progression scale ;Secondary Objective: -Clinical improvement of disease symptoms (reduction of temperature <37.5°C) -Time interval to negative SARS-CoV-2 PCR test result -Time interval to changes of cytokine release (IL-6, CRP) -Course of the oxygenation parameters (Horowitz Index) -Duration of hospitalization -Duration of artificial ventilation (if necessary) -Difference in Post covid functional status scale ;Primary end point(s): Time to clinical improvement of at least 1 point on the WHO Clinical Progression scale ;Timepoint(s) of evaluation of this end point: until the symptoms improve

—

Secondary

Measure	Time frame
Secondary end point(s): - Clinical improvement of disease symptoms (reduction of temperature <37.5°C) - Time interval to negative SARS-CoV-2 PCR test result - Time interval to changes of cytokine release (IL-6, CRP) - Course of the oxygenation parameters (Horowitz Index) - Duration of hospitalization - Duration of artificial ventilation (if necessary) - Difference in Post covid functional status scale ;Timepoint(s) of evaluation of this end point: until the symptoms improve	—

Measure

Time frame

Secondary end point(s): - Clinical improvement of disease symptoms (reduction of temperature <37.5°C) - Time interval to negative SARS-CoV-2 PCR test result - Time interval to changes of cytokine release (IL-6, CRP) - Course of the oxygenation parameters (Horowitz Index) - Duration of hospitalization - Duration of artificial ventilation (if necessary) - Difference in Post covid functional status scale ;Timepoint(s) of evaluation of this end point: until the symptoms improve

—

Countries

Austria

Contacts

Public ContactAbteilung für Anästhesiologie und I

Klinikum Klagenfurt am Wörthersee

markus.koestenberger@kabeg.at004346353826038

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026