Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

Sponsor
National Taiwan University Hospital
Study ID
NCT05770466
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • P1101 (Ropeginterferon alfa-2b) — DRUG
    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
  • 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 ( P1101combined with standard of care (SOC) compared with standard care alone in hospitalized adults with moderate COVID 19.

Key Dates

Start date
Apr 1, 2022
Status verified
Apr 2022
Primary completion
Dec 21, 2022
Completion
Jan 11, 2023

Study Design

Enrollment
134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Proportion of patients who are negative to SARS-CoV-2 at Day 8 [ Time Frame: Up to Day 8 ]

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