COVID-19Phase 2/3NCT05808322
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
A Phase 2/3 study testing 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 ( P1101 combined with standard of care (SOC) compared with standard care alone in adult COVID-19 patients with comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2023to 31 Dec 2024
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei
Wang-Huei Sheng, professor, 02-23123456 ext. 262104, whsheng@ntu.edu.tw
About this study
Official title: An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- 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.
Ropeginterferon alfa-2bDrug
Also called P1101
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.
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 |
|---|---|---|
| Study Group | Experimental | Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) Receives: Drug: 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.
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
Measured: Up to Day 57
Secondary outcomes (5)
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
Measured: Up to Day 43
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
Measured: Up to Day 43
Change of SpO2
The change of SpO2 from randomization to Day 15, 29, and 43, compared between the Study and Control groups
Measured: Up to Day 43
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
Measured: Up to Day 57
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
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion16 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang-Huei Sheng, M.D. Ph.D, Principal investigator, Center of Infection Control of National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808322
- Sponsor's protocol ID
- 202302136MIP-1
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu WD, Hou HA, Li KJ, Qin A, Tsai CY, Sheng WH. Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities. Adv Ther. 2024 Feb;41(2):847-856. doi: 10.1007/s12325-023-02715-7. Epub 2023 Nov 27.
PubMed 38010606
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
- ClinicalTrials.gov ID
- NCT05808322
- Acronym / sponsor ID
- 202302136MIP-1
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 16 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Apr 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 ( 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Ropeginterferon alfa-2bAlso: P1101A 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. | Drug | Study 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, Study Group |
Primary outcome
Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR)
Time frame: Up to Day 57
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
5 secondary outcomes
The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, Day 29, and Day 43
Time frame: Up to Day 43
Change from randomization in the clinical status
Time frame: Up to Day 43
Change of SpO2
Time frame: Up to Day 43
The occurrence and the accumulated duration (days) of supple-mental oxygen
Time frame: Up to Day 57
The occurrence and the accumulated duration (days) of mechanical ventilation
Time frame: Up to Day 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 38010606Liu WD, Hou HA, Li KJ, Qin A, Tsai CY, Sheng WH. Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities. Adv Ther. 2024 Feb;41(2):847-856. doi: 10.1007/s12325-023-02715-7. Epub 2023 Nov 27.
- 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.
Wang-Huei Sheng, M.D. Ph.D principal investigator
Center of Infection Control of National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang-Huei Sheng, M.D. Ph.D (886-2-23123456 ext. 67736, whsheng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR) (time frame: Up to Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808322, which also lists 1 linked publication.
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 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.