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

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ClinicalTrials.gov Identifier: NCT04480138
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Tracking Information
First Submitted Date  ICMJE July 20, 2020
First Posted Date  ICMJE July 21, 2020
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE August 11, 2020
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
  • PCR test [ Time Frame: Week 2 and Week 4 ]
    PCR for SARS-CoV-2 in pharyngeal swab
  • Supplemental Oxygen [ Time Frame: Week 2 and Week 4 ]
    Occurrence of supplemental Oxygen
  • Mechanical Ventilation [ Time Frame: Week 2 and Week 4 ]
    Occurrence of Mechanical Ventilation
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Week 2 and Week 4 ]
    Occurence of Adverse events
  • C-reactive protein (CRP) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker
  • Interleukin 6 (IL-6) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker
  • D-dimer [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker
  • Interferon gamma [ Time Frame: Week 2 and Week 4 ]
    type II class of interferons
  • Ferritin [ Time Frame: Week 2 and Week 4 ]
    proteins
  • TNF alpha [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker
  • Interleukin 1-β [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Pegylated Interferon-α2b
    • Other: Standard of Care
  • Active Comparator: Standard of Care

    Control: Standard of care

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

    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr Richa Vellanki +912717665555 ext 454 richa.vellanki@zyduscadila.com
Contact: Dr Deven Parmar, MD +912717665555 ext 451 deven.parmar@zydusdiscovery.ae
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04480138
Other Study ID Numbers  ICMJE PEGI.20.003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cadila Healthcare Limited
Study Sponsor  ICMJE Cadila Healthcare Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr Deven Parmar, MD Cadila Healthcare Ltd.
PRS Account Cadila Healthcare Limited
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP