- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770466
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- National Taiwan University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)
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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.
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Active Comparator: Control group
Treated with SOC alone
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who are negative to SARS-CoV-2 at Day 8
Time Frame: Up to Day 8
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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
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Up to Day 8
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Time to discharge from hospital
Time Frame: Up to Day 29
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Time to discharge from hospital according to the latest Taiwan CDC guidance for SARS-CoV-2 infection (From randomization to discharge)
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Up to Day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who are negative to SARS-CoV-2 at Day 5
Time Frame: Up to Day 5
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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
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Change in clinical status of patient at Day 5
Time Frame: Up to Day 5
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Change in clinical status of patient on WHO clinical progression scale at Day 5
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Up to Day 5
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Change in clinical status of patient at Day 8
Time Frame: Up to Day 8
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Change in clinical status of patient on WHO clinical progression scale at Day 8
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Up to Day 8
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Change of SpO2
Time Frame: Up to Day 29
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Change of SpO2 from baseline
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Up to Day 29
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Time from symptom onset to resolution of clinical signs and symptoms
Time Frame: Up to Day 29
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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.
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Up to Day 29
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Time from symptom onset to RT-PCR negative result
Time Frame: Up to Day 29
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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).
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Up to Day 29
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Time from RT-PCR positive result to the resolution of clinical signs and symptoms
Time Frame: Up to Day 29
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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)
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Up to Day 29
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Time from RT-PCR positive result to RT-PCR negative result
Time Frame: Up to Day 29
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Time from RT-PCR positive result (Ct value < 30) to RT-PCR negative result (Ct value ≥30)
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Up to Day 29
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Occurrence and duration (days) of supplemental oxygen
Time Frame: Up to Day 29
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Occurrence and duration (days) of supplemental oxygen
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Up to Day 29
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Occurrence and duration (days) of mechanical ventilation
Time Frame: Up to Day 29
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Occurrence and duration (days) of mechanical ventilation
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Up to Day 29
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Time to treatment with other antiviral agents within 8 days
Time Frame: Up to Day 8
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To evaluate the time to treatment with other antiviral agents within 8 days in the Ropeginterferon alfa-2b treatment group,
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Up to Day 8
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202108013MIPC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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