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

Primary Purpose

COVID-19

Status
Active
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
P1101 (Ropeginterferon alfa-2b)
SOC
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)

Treated with SOC alone

Outcomes

Primary Outcome Measures

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 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)

Secondary Outcome Measures

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
Change in clinical status of patient at Day 5
Change in clinical status of patient on WHO clinical progression scale at 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
Change of SpO2
Change of SpO2 from baseline
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 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 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 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)
Occurrence and duration (days) of supplemental oxygen
Occurrence and duration (days) of supplemental oxygen
Occurrence and duration (days) of mechanical ventilation
Occurrence and duration (days) of mechanical ventilation
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,

Full Information

First Posted
July 14, 2022
Last Updated
March 13, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05770466
Brief Title
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Treated with SOC alone
Intervention Type
Drug
Intervention Name(s)
P1101 (Ropeginterferon alfa-2b)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
SOC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who are negative to SARS-CoV-2 at Day 8
Description
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
Title
Time to discharge from hospital
Description
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
Secondary Outcome Measure Information:
Title
Proportion of patients who are negative to SARS-CoV-2 at Day 5
Description
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
Title
Change in clinical status of patient at Day 5
Description
Change in clinical status of patient on WHO clinical progression scale at Day 5
Time Frame
Up to Day 5
Title
Change in clinical status of patient at Day 8
Description
Change in clinical status of patient on WHO clinical progression scale at Day 8
Time Frame
Up to Day 8
Title
Change of SpO2
Description
Change of SpO2 from baseline
Time Frame
Up to Day 29
Title
Time from symptom onset to resolution of clinical signs and symptoms
Description
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
Title
Time from symptom onset to RT-PCR negative result
Description
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
Title
Time from RT-PCR positive result to the resolution of clinical signs and symptoms
Description
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
Title
Time from RT-PCR positive result to RT-PCR negative result
Description
Time from RT-PCR positive result (Ct value < 30) to RT-PCR negative result (Ct value ≥30)
Time Frame
Up to Day 29
Title
Occurrence and duration (days) of supplemental oxygen
Description
Occurrence and duration (days) of supplemental oxygen
Time Frame
Up to Day 29
Title
Occurrence and duration (days) of mechanical ventilation
Description
Occurrence and duration (days) of mechanical ventilation
Time Frame
Up to Day 29
Title
Time to treatment with other antiviral agents within 8 days
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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