Efficacy and safety of Interferon beta-1-a in mild to moderate COVID-19

Efficacy and safety of Interferon beta-1-a in the management of the outpatients with mild to moderate COVID-19: A preliminary study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120703010178N25

Enrollment

100

Registered

2021-08-09

Start date

2021-08-21

Completion date

Unknown

Last updated

2021-08-30

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 in the intervention group receive interferon ß-1a (ReciGen®) 12 million units subcutaneously every other day for three doses plus conservative therapy incl

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed COVID-19, based on reverse transcriptase-polymerase chain reaction (rt-PCR) Patients with mild to moderate COVID-19 Within 48 hours of the onset of the symptoms

Exclusion criteria

Exclusion criteria: Age younger than 18 years old Diagnosis of COVID-19 based on clinical criteria without positive rt-PCR results The onset of symptoms more than 48 hours Patients with severe to critical COVID-19 Immunocompromised state Receiving any antiviral or anti-inflammatory drug Lactation and pregnancy Liver enzymes 3 times higher than the normal range Psychotic disorders Platelet count below 50,000 Hemoglobin less than 10 grams per deciliter

Design outcomes

Primary

Measure	Time frame
Body temperature. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Thermometer.;Systolic blood pressure. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: sphygmomanometer.;Diastolic blood pressure. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: sphygmomanometer.;Respiratory rate. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: chronometer.;Pulse rate. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: chronometer.;Level of oxygen saturation in the peripheral circulation. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: pulse oximeter.	—

Measure

Time frame

Body temperature. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Thermometer.;Systolic blood pressure. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: sphygmomanometer.;Diastolic blood pressure. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: sphygmomanometer.;Respiratory rate. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: chronometer.;Pulse rate. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: chronometer.;Level of oxygen saturation in the peripheral circulation. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: pulse oximeter.

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Secondary

Measure	Time frame
Nausea. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.;Abdominal pain. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.;Injection site pain. Timepoint: After 7 days of the treatment. Method of measurement: Self reporting.;Myalgia. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.	—

Measure

Time frame

Nausea. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.;Abdominal pain. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.;Injection site pain. Timepoint: After 7 days of the treatment. Method of measurement: Self reporting.;Myalgia. Timepoint: In the beginning of the study and after 7 days of the treatment. Method of measurement: Self reporting.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Sistanizad

Shahid Beheshti University of Medical Sciences

sistanizadm@sbmu.ac.ir+98 21 8820 0118

Outcome results

None listed

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