Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) |
Drug: P1101 (Ropeginterferon alfa-2b)
Name: P1101 (Ropeginterferon alfa-2b)
Dosage form: pre-filled syringe
Strength: A single dose of 250 mcg/0.5 mL
Dosage and administration: 250 mcg per subcutaneous injection
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.
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.
|
| Active Comparator: Control group Treated with SOC alone |
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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients who are negative to SARS-CoV-2 at Day 8 [Up to 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
- Time to discharge from hospital [Up to Day 29]
Time to discharge from hospital according to the latest Taiwan CDC guidance for SARS-CoV-2 infection (From randomization to discharge)
Secondary Outcome Measures
- Proportion of patients who are negative to SARS-CoV-2 at Day 5 [Up to Day 5]
Proportion of patients who are negative to SARS-CoV-2 based on quantitative (Ct value ≥30) RT-PCR at Day 5 or discharge before Day 5 due to recovery
- Change in clinical status of patient at Day 5 [Up to Day 5]
Change in clinical status of patient on WHO clinical progression scale at Day 5
- Change in clinical status of patient at Day 8 [Up to Day 8]
Change in clinical status of patient on WHO clinical progression scale at Day 8
- Change of SpO2 [Up to Day 29]
Change of SpO2 from baseline
- Time from symptom onset to resolution of clinical signs and symptoms [Up to Day 29]
Time from the onset of clinical symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell) to the resolution of clinical signs and symptoms.
- Time from symptom onset to RT-PCR negative result [Up to Day 29]
Time from the onset of clinical symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell) to the RT-PCR negative result (Ct value ≥30).
- Time from RT-PCR positive result to the resolution of clinical signs and symptoms [Up to Day 29]
Time from RT-PCR positive result (Ct value < 30) to the resolution of clinical signs and symptoms related to COVID-19 (e.g., fever, cough, dyspnea or change in taste or smell)
- Time from RT-PCR positive result to RT-PCR negative result [Up to Day 29]
Time from RT-PCR positive result (Ct value < 30) to RT-PCR negative result (Ct value ≥30)
- Occurrence and duration (days) of supplemental oxygen [Up to Day 29]
Occurrence and duration (days) of supplemental oxygen
- Occurrence and duration (days) of mechanical ventilation [Up to Day 29]
Occurrence and duration (days) of mechanical ventilation
- Time to treatment with other antiviral agents within 8 days [Up to Day 8]
To evaluate the time to treatment with other antiviral agents within 8 days in the Ropeginterferon alfa-2b treatment group,
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability to comprehend and willingness to provide a written ICF before enter the study;
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Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
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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.
Exclusion Criteria:
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Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry.
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Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
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Patients who have SpO2 <93% on room air, respiratory frequency >30 breaths/min.
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Patients treated by dexamethasone before Day 1.
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Patients treated by supplemental oxygen (FiO2 >40%) before Day 1.
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Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <15 mL/min/1.73 m2).
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Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
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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.
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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).
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Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs.
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Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening.
13.Therapy with any anti-neoplastic, or immunomodulatory treatment within 1 month prior to screening.
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Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine within 1 month prior to screening.
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Use of an investigational medical product within 1 month prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202108013MIPC