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

Study Overview
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Brief Summary
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To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101combined with standard of care (SOC) compared with standard care alone in hospitalized adults with moderate COVID 19.

Official Title
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A Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in the Treatment of Patients With Moderate COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: P1101 (Ropeginterferon alfa-2b)
* Procedure: SOC


Participation Criteria
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Eligibility Criteria
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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). 11. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs. 12. 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. 14. Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine within 1 month prior to screening. 15. Use of an investigational medical product within 1 month prior to screening.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) | Drug: P1101 (Ropeginterferon alfa-2b)<br>* Name: P1101 (Ropeginterferon alfa-2b) Dosage form: pre-filled syringe Strength: A single dose of 250 mcg/0.5 mL Dosage and administration: 250 mcg per subcutaneous injection Mechanism of action (if known): Interferon work by binding to specific membrane receptors on the cell surface which in turn induce a complex sequence of intracellular events. These events include the induction of particular enzymes, suppression of cell proliferation, inhibition of virus replication in virus infected cells and immunomodulating activities. Pharmacological category: Antineoplastic and immunomodulating agents/ Immunostimulants/ Cytokines<br>Procedure: SOC<br>* SOC includes infection prevention and control measures, supportive care, dexamethasone, and antiviral agents. The SOC is based on the Taiwan Centers for Disease Control (CDC) guidance and investigator's discretion.<br>|
| Active Comparator: Control group<br>Treated with SOC alone | Procedure: SOC<br>* SOC includes infection prevention and control measures, supportive care, dexamethasone, and antiviral agents. The SOC is based on the Taiwan Centers for Disease Control (CDC) guidance and investigator's discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who are negative to SARS-CoV-2 at Day 8 | Proportion of patients who are negative to SARS-CoV-2 based on quantitative (Ct value ≥30) RT-PCR at Day 8 or discharge before Day 8 due to recovery | Up to Day 8 | 
| Time to discharge from hospital | Time to discharge from hospital according to the latest Taiwan CDC guidance for SARS-CoV-2 infection (From randomization to discharge) | Up to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who are negative to SARS-CoV-2 at Day 5 | Proportion of patients who are negative to SARS-CoV-2 based on quantitative (Ct value ≥30) RT-PCR at Day 5 or discharge before Day 5 due to recovery | Up to Day 5 | 
| Change in clinical status of patient at Day 5 | Change in clinical status of patient on WHO clinical progression scale at Day 5 | Up to Day 5 | 
| Change in clinical status of patient at Day 8 | Change in clinical status of patient on WHO clinical progression scale at Day 8 | Up to Day 8 | 
| Change of SpO2 | Change of SpO2 from baseline | Up to Day 29 | 
| Time from symptom onset to resolution of clinical signs and symptoms | Time from the onset of clinical symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell) to the resolution of clinical signs and symptoms. | Up to Day 29 | 
| Time from symptom onset to RT-PCR negative result | Time from the onset of clinical symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell) to the RT-PCR negative result (Ct value ≥30). | Up to Day 29 | 
| Time from RT-PCR positive result to the resolution of clinical signs and symptoms | Time from RT-PCR positive result (Ct value < 30) to the resolution of clinical signs and symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell) | Up to Day 29 | 
| Time from RT-PCR positive result to RT-PCR negative result | Time from RT-PCR positive result (Ct value < 30) to RT-PCR negative result (Ct value ≥30) | Up to Day 29 | 
| Occurrence and duration (days) of supplemental oxygen | Occurrence and duration (days) of supplemental oxygen | Up to Day 29 | 
| Occurrence and duration (days) of mechanical ventilation | Occurrence and duration (days) of mechanical ventilation | Up to Day 29 | 
| Time to treatment with other antiviral agents within 8 days | To evaluate the time to treatment with other antiviral agents within 8 days in the Ropeginterferon alfa-2b treatment group, | Up to Day 8 |