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Study aim
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Efficacy and safety of Interferon β-1a in the management of the outpatients with mild to moderate COVID-19
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Design
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A randomized clinical trial, case-control, parallel with a cross-sectional design for 6 months. The randomization was performed by permuted block randomization and block sizes of 4.
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Settings and conduct
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Eligible patients who are referred to the Saghi Clinic in Tehran, Iran, are randomly divided into intervention and control groups. Patients in the intervention group receive interferon β-1a (ReciGen®) plus conservative therapy whereas patients in the control group received only conservative therapy.
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Participants/Inclusion and exclusion criteria
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Including criteria are confirmed COVID-19, based on reverse transcriptase-polymerase chain reaction, mild to moderate COVID-19, and within 48 hours of the onset of the symptoms; 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, liver enzymes 3 times higher than the normal range, psychotic disorders, platelet count below 50,000, hemoglobin less than 10 grams per deciliter, lactation and pregnancy were considered as exclusion criteria.
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Intervention groups
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Patients in the intervention group receive interferon β-1a 12 million units subcutaneously every other day for three doses plus conservative therapy including acetaminophen and antihistamine.
Patients in the control group received only conservative therapy.
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Main outcome variables
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body temperature; systolic blood pressure; diastolic blood pressure; respiratory rate; pulse rate; and level of oxygen saturation in the peripheral circulation.