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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) |
|
| Control group | Active Comparator | Treated with SOC alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P1101 (Ropeginterferon alfa-2b) | Drug |
|
| 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 |
| 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 |
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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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| SOC | Procedure | 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. |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |