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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
1. Name: P1101 (Ropeginterferon alfa-2b) 2. Dosage form: pre-filled syringe 3. Strength: A single dose of 250 mcg/0.5 mL 4. Dosage and administration: 250 mcg per subcutaneous injection 5. 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. 6. Pharmacological category: Antineoplastic and immunomodulating agents/ Immunostimulants/ Cytokines
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.
National Taiwan University Hospital
Taipei, Taiwan
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
Time frame: 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)
Time frame: Up to Day 29
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
Time frame: 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
Time frame: 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
Time frame: Up to Day 8
Change of SpO2
Change of SpO2 from baseline
Time frame: 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.
Time frame: Up to Day 29
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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).
Time frame: 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)
Time frame: 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)
Time frame: Up to Day 29
Occurrence and duration (days) of supplemental oxygen
Occurrence and duration (days) of supplemental oxygen
Time frame: Up to Day 29
Occurrence and duration (days) of mechanical ventilation
Occurrence and duration (days) of mechanical ventilation
Time frame: 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,
Time frame: Up to Day 8