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

NCT05770466 | Completed Phase 3

• 1 other identifier: 202108013MIPC
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who are negative to SARS-CoV-2 at Day 8

  Proportion of patients who are negative to SARS-CoV-2 based on quantitative (Ct value ≥30) RT-PCR at Day 8 or discharge before Day 8 due to recovery

  Up to Day 8

• Time to discharge from hospital

  Time to discharge from hospital according to the latest Taiwan CDC guidance for SARS-CoV-2 infection (From randomization to discharge)

  Up to Day 29

Secondary Outcomes (11)

• Proportion of patients who are negative to SARS-CoV-2 at Day 5

  Up to Day 5

• Change in clinical status of patient at Day 5

  Up to Day 5

• Change in clinical status of patient at Day 8

  Up to Day 8

• Change of SpO2

  Up to Day 29

• Time from symptom onset to resolution of clinical signs and symptoms

  Up to Day 29

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: P1101 (Ropeginterferon alfa-2b); Procedure: SOC

Control group

ACTIVE COMPARATOR

Treated with SOC alone

Procedure: SOC

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

Experimental 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; Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to comprehend and willingness to provide a written ICF before enter the study;
• Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
• Hospitalized patient with a diagnosis of COVID-19 on the basis of a positive# reverse transcriptase polymerase chain reaction (RT-PCR) with moderate## disease on admission###. #: Ct value \<30. ##:Disease severity as defined by the treatment guidance of Taiwan Centers for Disease Control (CDC):
• \> Moderate: Pneumonia patients without severe symptoms, blood oxygen saturation ≥93% without supplemental oxygen equipment (on room air); ###: Confirmed positive RT-PCR result ≤ 4 days prior to screening visit is eligible
• Agrees to the collection of 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.
• Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
• Patients who have SpO2 \<93% on room air, respiratory frequency \>30 breaths/min.
• Patients treated by dexamethasone before Day 1.
• Patients treated by supplemental oxygen (FiO2 \>40%) before Day 1.
• Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. 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, e.g. hypersensitivity 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: major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt).
• \. 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.
• Therapy with any anti-neoplastic, or immunomodulatory treatment within 1 month prior to screening.
• \. Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine 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

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: March 15, 2023
• Study Start: April 1, 2022
• Primary Completion: December 21, 2022
• Study Completion: January 11, 2023
• Last Updated: April 16, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)