Interferon beta 1b in COVID-19

Efficacy and safety evaluation of therapeutic regimen of lopinavir/ritonavir and interferon beta 1b in patients with COVID-19

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190804044429N1

Enrollment

Registered

2020-04-11

Start date

2020-03-25

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

COVID-19 pneumonia. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: National therapeutic guideline including hydroxychloroquine 400 mg stat and lopinavir/ritonavir plus 250 mcg interferon beta 1 b subcutaneous injection every other

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Ghazaeian

Mazandaran University of Medical Sciences

ghazaeianm@gmail.com+98 11 3334 3011

Outcome results

None listed

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