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

Sponsor
National Taiwan University Hospital
Study ID
NCT05808322
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Mar 2023
Primary completion
May 16, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)
  • Active Comparator: Control Group
    Treated with SOC alone

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 ]

Central Contacts

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