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Interferon beta 1b in COVID-19

Phase 2
Recruiting
Conditions
COVID-19 pneumonia.
COVID-19, virus identified
U07.1
Registration Number
IRCT20190804044429N1
Lead Sponsor
Mazandaran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
70
Inclusion Criteria

All adult patients with highly suspected or confirmed COVID-19 who are candidate for hospitalization and starting therapeutic regimen with lopinavir/ritonavir and hydroxychloroquine

Exclusion Criteria

History of allergy to any drugs of therapeutic regimen , pregnancy and lactation, renal and hepatic disease, heart failure, uncontrolled depression and untreated thyroid disorders and seizure history.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response to therapeutic regimen by respiratory rate. Timepoint: Daily. Method of measurement: physical exam.;Clinical response to therapeutic regimen by blood oxygen saturation. Timepoint: daily. Method of measurement: pulse oximeter.;Clinical response to therapeutic regimen by fever. Timepoint: daily. Method of measurement: thermometer.;Therapeutic regimen safety. Timepoint: daily. Method of measurement: patient tolerability.;LDH level reduction. Timepoint: three times weekly. Method of measurement: laboratory test.;CRP level reduction. Timepoint: three times weekly. Method of measurement: laboratory test.;Lymphocyte count recovery. Timepoint: daily. Method of measurement: laboratory test.;Cough recovery. Timepoint: daily. Method of measurement: physical exam.
Secondary Outcome Measures
NameTimeMethod
Injection site reactions,. Timepoint: Daily. Method of measurement: history taking.;Hospital stay duration. Timepoint: End of treatment. Method of measurement: Patient file.;Mortality rate. Timepoint: Daily. Method of measurement: patient file.;Flu-like symptoms. Timepoint: Daily. Method of measurement: history taking.;Liver enzymes changing. Timepoint: twice weekly. Method of measurement: laboratory test.
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