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

Phase 1

• Conditions: Patients admitted to hospital with a SARS CoV 2 infection with fever and other COVID relevant symptoms; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005527-36-AT
• Lead Sponsor: Gesellschaft für Zelltherapie mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

•< 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>-Time interval to negative SARS-CoV-2 PCR test result <br>-Time interval to changes of cytokine release (IL-6, CRP)<br>-Course of the oxygenation parameters (Horowitz Index)<br>-Duration of hospitalization <br>-Duration of artificial ventilation (if necessary) <br>-Difference in Post covid functional status scale<br><br>;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 Outcome Measures

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