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.
Drug: Human Ezrin Peptide 1 (HEP1)
HEP-1 will be administrated s.c. into the lower abdominal wall
induction dosage: 2 mg Ezrin in 2 ml physiological saline applied s.c.,one injection every 12 hours until symptoms disappear followed by
maintenance dosage: 0.2 mg Ezrin in 1 ml physiological saline solution s.c 1/day for 10 days
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.
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
Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Investigator: Farzad Ashrafi
farzad.ashrafi@sbmu.ac.ir