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Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
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

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

Inclusion Criteria: 1. Willingness to provide a written ICF before entering the study; 2. Male or non-pregnant female patients, ≥ 18 years of age at the time of enrolment (or other age required by local regulations); 3. Patient with the diagnosis of COVID-19 and with the Ct value <30 in SARS-CoV-2 RT-PCR; 4. Patients with any comorbidity below at screening: Hematologic cancer; Solid tumor that requires chemotherapy or other systemic therapy; Well controlled autoimmune diseases; or any other medical comorbidities that requires immunosuppressive therapy; 5. Non-responder to the treatment of any other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir; or patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has Ct <30 14 days after the symptom onset of COVID-19. Non-responder is defined as a patient who received remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir but still has Ct <30 14 days after the symptom onset of COVID-19. 6. Agrees to the collection of nasopharyngeal or pharyngeal swabs and blood sample as per protocol. Exclusion Criteria: 1. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry; 2. Chronic kidney disease with eGFR <15 mL/min/1.73 m2; 3. Females who are breast-feeding, lactating, pregnant or intending to become pregnant; 4. Known history of severe allergic or hypersensitivity reactions to the active substance or to any of the excipients of ropeginterferon alfa-2b; 5. 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, e.g., major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt) or poorly controlled autoimmune diseases; 6. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs; 7. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening; 8. 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

Study Group

Control Group

Arm Description

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

Treated with SOC alone

Outcomes

Primary Outcome Measures

Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR)
To compare the time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative RT-PCR between the Study and Control groups

Secondary Outcome Measures

The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, Day 29, and Day 43
The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, 29, and 43, compared between the Study and Control groups
Change from randomization in the clinical status
The change from randomization in the clinical status of patient on WHO clinical progression scale at Day 15, 29, and 43, compared between the Study and Control groups
Change of SpO2
The change of SpO2 from randomization to Day 15, 29, and 43, compared between the Study and Control groups
The occurrence and the accumulated duration (days) of supple-mental oxygen
To compare the occurrence and the accumulated duration (days) of supplemental oxygen between the Study and Control groups
The occurrence and the accumulated duration (days) of mechanical ventilation
To compare the occurrence and the accumulated duration (days) of mechanical ventilation between the Study and Control groups

Full Information

First Posted
April 9, 2023
Last Updated
April 9, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05808322
Brief Title
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
Official Title
An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
May 16, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined with standard of care (SOC) compared with standard care alone in adult COVID-19 patients with comorbidities.
Detailed Description
This is a multi-center, open label, control study to evaluate the efficacy and safety of ropeginterferon alfa-2b in the treatment of adult COVID-19 patients with comorbidities. Adult COVID-19 patient with the specific comorbidities and being non-responder to the other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and molnupiravir, or the patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has positive result (Ct <30) 14 days after the symptom onset of COVID-19 will be enrolled. The eligible patients will be randomized to receive the ropeginterferon alfa-2b plus SOC (study group) or to receive SOC alone (control group). For study group, a single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit. For patients who still have positive result (Ct <30) in SARS-CoV-2 RT-PCR at Day 15 and Day 29, the second dose of ropeginterferon alfa-2b at 350 μg and the third dose at 500 μg will be administered, respectively. For control group, patients will receive the SOC alone. The efficacy and safety of ropeginterferon alfa-2b will be evaluated.

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study 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)
Ropeginterferon alfa-2b
Other Intervention Name(s)
P1101
Intervention Description
A maximum of 3 doses of ropeginterferon alfa-2b will be given biweekly during the whole study period. A single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit. SARS-CoV-2 antigen test will be conducted at D15 and D29 visits. For patients who still have positive result in SARS-CoV-2 antigen test at Day 15 visit, the second dose of ropeginterferon alfa-2b at 350 μg will be subsequently administered at Day 15 visit. For patients who still have positive result in SARS-CoV-2 antigen test at Day 29 visit, the third dose of ropeginterferon alfa-2b at 500 μg will be administered at Day 29 visit.
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
Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR)
Description
To compare the time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative RT-PCR between the Study and Control groups
Time Frame
Up to Day 57
Secondary Outcome Measure Information:
Title
The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, Day 29, and Day 43
Description
The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, 29, and 43, compared between the Study and Control groups
Time Frame
Up to Day 43
Title
Change from randomization in the clinical status
Description
The change from randomization in the clinical status of patient on WHO clinical progression scale at Day 15, 29, and 43, compared between the Study and Control groups
Time Frame
Up to Day 43
Title
Change of SpO2
Description
The change of SpO2 from randomization to Day 15, 29, and 43, compared between the Study and Control groups
Time Frame
Up to Day 43
Title
The occurrence and the accumulated duration (days) of supple-mental oxygen
Description
To compare the occurrence and the accumulated duration (days) of supplemental oxygen between the Study and Control groups
Time Frame
Up to Day 57
Title
The occurrence and the accumulated duration (days) of mechanical ventilation
Description
To compare the occurrence and the accumulated duration (days) of mechanical ventilation between the Study and Control groups
Time Frame
Up to Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Willingness to provide a written ICF before entering the study; 2. Male or non-pregnant female patients, ≥ 18 years of age at the time of enrolment (or other age required by local regulations); 3. Patient with the diagnosis of COVID-19 and with the Ct value <30 in SARS-CoV-2 RT-PCR; 4. Patients with any comorbidity below at screening: Hematologic cancer; Solid tumor that requires chemotherapy or other systemic therapy; Well controlled autoimmune diseases; or any other medical comorbidities that requires immunosuppressive therapy; 5. Non-responder to the treatment of any other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir; or patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has Ct <30 14 days after the symptom onset of COVID-19. Non-responder is defined as a patient who received remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir but still has Ct <30 14 days after the symptom onset of COVID-19. 6. Agrees to the collection of nasopharyngeal or pharyngeal swabs and blood sample as per protocol. Exclusion Criteria: 1. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry; 2. Chronic kidney disease with eGFR <15 mL/min/1.73 m2; 3. Females who are breast-feeding, lactating, pregnant or intending to become pregnant; 4. Known history of severe allergic or hypersensitivity reactions to the active substance or to any of the excipients of ropeginterferon alfa-2b; 5. 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, e.g., major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt) or poorly controlled autoimmune diseases; 6. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs; 7. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening; 8. Use of an investigational medical product within 1 month prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang-Huei Sheng, M.D. Ph.D
Phone
886-2-23123456
Ext
67736
Email
whsheng@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang-Huei Sheng, M.D. Ph.D
Organizational Affiliation
Center of Infection Control of National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang-Huei Sheng, professor
Phone
02-23123456
Ext
262104
Email
whsheng@ntu.edu.tw

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 Adult COVID-19 Patients With Comorbidities

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