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

NCT05770466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-04-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

P1101 (Ropeginterferon alfa-2b)

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

PROCEDURE

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-21
Completion
2023-01-11

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05770466 on ClinicalTrials.gov