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

Phase 3
Conditions
COVID-19.
Coronavirus infection, unspecified
B34.2
Registration Number
IRCT20100601004076N27
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
240
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Morbidity. Timepoint: At the time of hospitalization, every 3 days until the day of discharge from the hospital. Method of measurement: Vital Signs Examination.
Secondary Outcome Measures
NameTimeMethod
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