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Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04480138
Recruitment Status : Active, not recruiting
First Posted : July 21, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Pegylated Interferon-α2b Other: Standard of Care Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pegylated Interferon-α2b + Standard of care

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.

 Drug: Pegylated Interferon-α2b
1 mcg/kg on day 1 and day 8 after safety evaluations.

Other: Standard of Care
Standard of care as per local authority
Active Comparator: Standard of Care

Control: Standard of care

Standard of care treatment will be provided as per regulatory recommendation and approval.

 Other: Standard of Care
Standard of care as per local authority


Outcome Measures
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Primary Outcome Measures :
  1. Change in Clinical status of subject on a 7-point ordinal scale [ Time Frame: Week 2 ]
    1. Not hospitalized, no limitations on activities.
    2. Not hospitalized, limitation on activities.
    3. Hospitalized, not requiring supplemental oxygen.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
    6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    7. Death.


Secondary Outcome Measures :
  1. PCR test [ Time Frame: Week 2 and Week 4 ]
    PCR for SARS-CoV-2 in pharyngeal swab

  2. Supplemental Oxygen [ Time Frame: Week 2 and Week 4 ]
    Occurrence of supplemental Oxygen

  3. Mechanical Ventilation [ Time Frame: Week 2 and Week 4 ]
    Occurrence of Mechanical Ventilation

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Week 2 and Week 4 ]
    Occurence of Adverse events

  5. C-reactive protein (CRP) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  6. Interleukin 6 (IL-6) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  7. D-dimer [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  8. Interferon gamma [ Time Frame: Week 2 and Week 4 ]
    type II class of interferons

  9. Ferritin [ Time Frame: Week 2 and Week 4 ]
    proteins

  10. TNF alpha [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  11. Interleukin 1-β [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to comprehend and willingness to sign a written ICF for the study.
  2. Male or non-pregnant females, ≥18 years of age at the time of enrolment.
  3. Understands and agrees to comply with planned study procedures.
  4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
  5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
  6. Patients with SpO2 > 93% and respiratory rate <30 breaths/min.

  7. Illness of any duration, and at least one of the following:

    1. Radiographic infiltrates by imaging (chest x-ray)
    2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
  8. Women of childbearing potential must agree to use at least one primary form of contraception

Exclusion Criteria:

  1. ALT/AST >5 times the upper limit of normal.
  2. Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
  3. Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
  4. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
  5. Pregnant or breast feeding.
  6. Allergy to any study medication or usage of test drug during last 14 days prior to screening
  7. 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.
  8. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
  9. Prolong QT interval (>450 ms).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480138


Locations
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Mexico
Avant Sante site 2
Zapopan, Jalisco, Mexico
Avant Sante Site 1
Monterrey, Mexico
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
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Study Director: Dr Deven Parmar, MD Cadila Healthcare Ltd.
More Information
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Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT04480138    
Other Study ID Numbers: PEGI.20.003
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents