COVID-19Phase 3NCT05770466
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.
A Phase 3 study testing P1101 (Ropeginterferon alfa-2b) and SOC in people with COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- P1101 (Ropeginterferon alfa-2b) and SOC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2022to 11 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- P1101 (Ropeginterferon alfa-2b), SOC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 (Ropeginterferon alfa-2b)Drug
- 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
SOCProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) Receives: Drug: P1101 (Ropeginterferon alfa-2b); Procedure: SOC |
| Control group | Active comparator | Treated with SOC alone Receives: Procedure: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Up to Day 29
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: Up to Day 8
Change of SpO2
Change of SpO2 from baseline
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Up to Day 29
Occurrence and duration (days) of supplemental oxygen
Occurrence and duration (days) of supplemental oxygen
Measured: Up to Day 29
Occurrence and duration (days) of mechanical ventilation
Occurrence and duration (days) of mechanical ventilation
Measured: 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,
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2022
- Primary completion21 Dec 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770466
- Sponsor's protocol ID
- 202108013MIPC
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05770466
- Acronym / sponsor ID
- 202108013MIPC
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: P1101 (Ropeginterferon alfa-2b), Procedure: SOCTreated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) |
| Control group | Active comparator | Procedure: SOCTreated with SOC alone |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1101 (Ropeginterferon alfa-2b)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 | Drug | Experimental group |
| SOCSOC 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. | Procedure or surgery | Control group, Experimental group |
Primary outcome
Proportion of patients who are negative to SARS-CoV-2 at Day 8
Time frame: Up to 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 frame: Up to Day 29
Time to discharge from hospital according to the latest Taiwan CDC guidance for SARS-CoV-2 infection (From randomization to discharge)
11 secondary outcomes
Proportion of patients who are negative to SARS-CoV-2 at Day 5
Time frame: Up to Day 5
Change in clinical status of patient at Day 5
Time frame: Up to Day 5
Change in clinical status of patient at Day 8
Time frame: Up to Day 8
Change of SpO2
Time frame: Up to Day 29
Time from symptom onset to resolution of clinical signs and symptoms
Time frame: Up to Day 29
Time from symptom onset to RT-PCR negative result
Time frame: Up to Day 29
Time from RT-PCR positive result to the resolution of clinical signs and symptoms
Time frame: Up to Day 29
Time from RT-PCR positive result to RT-PCR negative result
Time frame: Up to Day 29
Occurrence and duration (days) of supplemental oxygen
Time frame: Up to Day 29
Occurrence and duration (days) of mechanical ventilation
Time frame: Up to Day 29
Time to treatment with other antiviral agents within 8 days
Time frame: Up to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P1101 (Ropeginterferon alfa-2b) and SOC in people with COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are negative to SARS-CoV-2 at Day 8 (time frame: Up to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.