Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19

Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19 Referred to Selected Hospitals of Tehran University of Medical Sciences: A Clinical Trial Study (Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100601004076N27

Enrollment

240

Registered

2022-01-02

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

COVID-19. Coronavirus infection, unspecified

Interventions

Intervention 1: Intervention group: Patients will receive 10 ml (150 mg) of Septimib at the first day and 20 ml (30 mg) from the second day (minimum for one week and maximum for two weeks) in addition

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Informed and voluntary oral and written consent of the patient or his / her guardian to participate in the study Age over 18 years SARS-CoV-2 virus PCR test positive or having one of the following conditions: Strong symptoms of COVID-19 disease, including fever, dry cough, and shortness of breath CT scan (HRCT or Spiral CT) that shows involvement with Cornavirus (at least 40% of lung involvement), especially ground glass in the peripheral or base of the lungs Patients suffering from life-threatening complications due to COVID-19 disease including ARDS, myocarditis, sepsis, cytokine storm (with ESR above 100 or platelet decline over 3 days or elevated D-Dimer above normal or LDH above normal).

Exclusion criteria

Exclusion criteria: Individuals whose Covid-19 test has not been approved Individuals who use drugs Individuals who drink alcohol Individuals who use immunosuppressive drugs Individuals under chemotherapy or radiotherapy Individuals who use growth hormone, testosterone and anabolic steroids The patient is pregnant or breastfeeding.

Design outcomes

Secondary

Measure	Time frame
Fever. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Headache. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Nausea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Shivering. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Rhinitis. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Dry Cough. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Myalgia. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Diarrhea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Shortness of breath. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Weakness and lethargy. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Blood Pressure. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clini	—

Measure

Time frame

Fever. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Headache. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Nausea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Shivering. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Rhinitis. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Dry Cough. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Myalgia. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Diarrhea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Shortness of breath. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Weakness and lethargy. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination.;Blood Pressure. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clini

—

Primary

Measure	Time frame
Morbidity. Timepoint: At the time of hospitalization, every 3 days until the day of discharge from the hospital. Method of measurement: Vital Signs Examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Khorram Khorshid

University of social welfare and rehabilitation sciences

hrkhkh@yahoo.com+98 21 7173 2000

Outcome results

None listed

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