Corona Virus Infection, Covid19, Treatment
Conditions
Keywords
COVID19, Treatment, Ezrin peptide, HEP-1
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.
Interventions
DRUGHuman 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
DRUGPlacebo
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.
Sponsors
praxisgemeinschaft für zelltherapie
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical improvement of disease symptoms | 7 days |
| Duration of Hospitalization | 28 days |
| Duration of artificial ventilation | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 | 28 days | — |
| CT Severity score | 28 days | Range 0-40 |
| CRP | 28 days | — |
| TNF | 28 days | — |
| CBC | 28 days | — |
| IL-1 | 28 days | — |
Countries
Iran
Outcome results
None listed