Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

Inclusion criteria

• Ability to comprehend and willingness to provide a written ICF before enter the study;
• Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
• Hospitalized patient with a diagnosis of COVID-19 on the basis of a positive# reverse transcriptase polymerase chain reaction (RT-PCR) with moderate## disease on admission###. #: Ct value <30. ##:Disease severity as defined by the treatment guidance of Taiwan Centers for Disease Control (CDC):

> Moderate: Pneumonia patients without severe symptoms, blood oxygen saturation ≥93% without supplemental oxygen equipment (on room air); ###: Confirmed positive RT-PCR result ≤ 4 days prior to screening visit is eligible

• Agrees to the collection of pharyngeal swabs and blood sample as per protocol.

Exclusion criteria

• Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry.
• Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
• Patients who have SpO2 <93% on room air, respiratory frequency >30 breaths/min.
• Patients treated by dexamethasone before Day 1.
• Patients treated by supplemental oxygen (FiO2 >40%) before Day 1.
• Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <15 mL/min/1.73 m2).
• Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
• Known history of severe allergic or hypersensitivity reactions, e.g. hypersensitivity to the active substance or to any of the excipients of ropeginterferon alfa-2b.
• Known history or presence of poorly controlled or clinically significant medical conditions that are not suitable to be enrolled, at the discretion of the investigator: major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt).

• Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs.

• Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening.

13.Therapy with any anti-neoplastic, or immunomodulatory treatment within 1 month prior to screening.

• Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine within 1 month prior to screening.

• Use of an investigational medical product within 1 month prior to screening.