Back to resultsPegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Pegylated Interferon-α2b
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male or non-pregnant females, ≥18 years of age at the time of enrolment.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
- Patients with SpO2 > 93% and respiratory rate <30 breaths/min.
Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray)
- Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
- Women of childbearing potential must agree to use at least one primary form of contraception
Exclusion Criteria:
- ALT/AST >5 times the upper limit of normal.
- Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
- Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
- Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
- Pregnant or breast feeding.
- Allergy to any study medication or usage of test drug during last 14 days prior to screening
- Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
- Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
- Prolong QT interval (>450 ms).
Sites / Locations
- Avant Sante site 2
- Avant Sante Site 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pegylated Interferon-α2b + Standard of care
Standard of Care
Arm Description
Test :- Pegylated Interferon-α2b + Standard of care (SOC) Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
Control: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval.
Outcomes
Primary Outcome Measures
Change in Clinical status of subject on a 7-point ordinal scale
Not hospitalized, no limitations on activities.
Not hospitalized, limitation on activities.
Hospitalized, not requiring supplemental oxygen.
Hospitalized, requiring supplemental oxygen.
Hospitalized, on non-invasive ventilation or high flow oxygen devices.
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Death.
Secondary Outcome Measures
PCR test
PCR for SARS-CoV-2 in pharyngeal swab
Supplemental Oxygen
Occurrence of supplemental Oxygen
Mechanical Ventilation
Occurrence of Mechanical Ventilation
Incidence of Treatment-Emergent Adverse Events
Occurence of Adverse events
C-reactive protein (CRP)
Inflammatory Biomarker
Interleukin 6 (IL-6)
Inflammatory Biomarker
D-dimer
Inflammatory Biomarker
Interferon gamma
type II class of interferons
Ferritin
proteins
TNF alpha
Inflammatory Biomarker
Interleukin 1-β
Inflammatory Biomarker
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04480138
Brief Title
Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Official Title
A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to non availability of eligible subjects and slow recruitment
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydus Lifesciences Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
Detailed Description
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegylated Interferon-α2b + Standard of care
Arm Type
Experimental
Arm Description
Test :- Pegylated Interferon-α2b + Standard of care (SOC)
Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Control: Standard of care
Standard of care treatment will be provided as per regulatory recommendation and approval.
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon-α2b
Intervention Description
1 mcg/kg on day 1 and day 8 after safety evaluations.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care as per local authority
Primary Outcome Measure Information:
Title
Change in Clinical status of subject on a 7-point ordinal scale
Description
Not hospitalized, no limitations on activities.
Not hospitalized, limitation on activities.
Hospitalized, not requiring supplemental oxygen.
Hospitalized, requiring supplemental oxygen.
Hospitalized, on non-invasive ventilation or high flow oxygen devices.
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Death.
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
PCR test
Description
PCR for SARS-CoV-2 in pharyngeal swab
Time Frame
Week 2 and Week 4
Title
Supplemental Oxygen
Description
Occurrence of supplemental Oxygen
Time Frame
Week 2 and Week 4
Title
Mechanical Ventilation
Description
Occurrence of Mechanical Ventilation
Time Frame
Week 2 and Week 4
Title
Incidence of Treatment-Emergent Adverse Events
Description
Occurence of Adverse events
Time Frame
Week 2 and Week 4
Title
C-reactive protein (CRP)
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
Interleukin 6 (IL-6)
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
D-dimer
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
Interferon gamma
Description
type II class of interferons
Time Frame
Week 2 and Week 4
Title
Ferritin
Description
proteins
Time Frame
Week 2 and Week 4
Title
TNF alpha
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
Interleukin 1-β
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study.
Male or non-pregnant females, ≥18 years of age at the time of enrolment.
Understands and agrees to comply with planned study procedures.
Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
Patients with SpO2 > 93% and respiratory rate <30 breaths/min.
Illness of any duration, and at least one of the following:
Radiographic infiltrates by imaging (chest x-ray)
Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
Women of childbearing potential must agree to use at least one primary form of contraception
Exclusion Criteria:
ALT/AST >5 times the upper limit of normal.
Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
Pregnant or breast feeding.
Allergy to any study medication or usage of test drug during last 14 days prior to screening
Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
Prolong QT interval (>450 ms).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Deven Parmar, MD
Organizational Affiliation
Cadila Healthcare Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Avant Sante site 2
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Avant Sante Site 1
City
Monterrey
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
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