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

NCT05808322 | Unknown Phase 2

• 1 other identifier: 202302136MIP-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Up to Day 43

• Change from randomization in the clinical status

  Up to Day 43

• Change of SpO2

  Up to Day 43

• The occurrence and the accumulated duration (days) of supple-mental oxygen

  Up to Day 57

• The occurrence and the accumulated duration (days) of mechanical ventilation

  Up to Day 57

Study Arms (2)

Study Group

EXPERIMENTAL

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

Drug: Ropeginterferon alfa-2b; Procedure: SOC

Control Group

ACTIVE COMPARATOR

Treated with SOC alone

Procedure: SOC

Interventions

Ropeginterferon alfa-2b 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.

Also known as: P1101

Study Group

SOC 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; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willingness to provide a written ICF before entering the study;
• \. Male or non-pregnant female patients, ≥ 18 years of age at the time of enrolment (or other age required by local regulations);
• \. Patient with the diagnosis of COVID-19 and with the Ct value \<30 in SARS-CoV-2 RT-PCR;
• \. 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;
• \. 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.
• \. Agrees to the collection of nasopharyngeal or pharyngeal swabs and blood sample as per protocol.

You may not qualify if:

• \. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry;
• \. Chronic kidney disease with 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 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, 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;
• \. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs;
• \. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening;
• \. Use of an investigational medical product within 1 month prior to screening.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38010606 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wang-Huei Sheng, M.D. Ph.D

  Center of Infection Control of National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

886-2-23123456; whsheng@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 11, 2023
• Study Start: May 15, 2023
• Primary Completion: May 16, 2024
• Study Completion: December 31, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)