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

NCT ID: NCT05808322

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-12-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

Ropeginterferon alfa-2b

Intervention Type: DRUG

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.

SOC

Intervention Type: PROCEDURE

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.

Control Group

Treated with SOC alone

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: PROCEDURE

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.

Interventions

Ropeginterferon alfa-2b

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: DRUG

SOC

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.

Intervention Type: PROCEDURE

Other Intervention Names

P1101

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:

1. Hematologic cancer;

2. Solid tumor that requires chemotherapy or other systemic therapy;

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang-Huei Sheng, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Center of Infection Control of National University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Wang-Huei Sheng, M.D. Ph.D

Role: CONTACT

whsheng@ntu.edu.tw

886-2-23123456 ext. 67736

Facility Contacts

Wang-Huei Sheng, professor

Role: primary

whsheng@ntu.edu.tw

02-23123456 ext. 262104

References

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.

Reference Type: DERIVED

PMID: 38010606 (View on PubMed)

Other Identifiers

202302136MIP-1

Identifier Type: -

Identifier Source: org_study_id