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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Covid19

Intervention / Treatment
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* Drug: Pegylated Interferon-α2b
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated Interferon-α2b + Standard of care<br>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<br>* 1 mcg/kg on day 1 and day 8 after safety evaluations.<br>Other: Standard of Care<br>* Standard of care as per local authority<br>|
| Active Comparator: Standard of Care<br>Control: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval. | Other: Standard of Care<br>* Standard of care as per local authority<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR test | PCR for SARS-CoV-2 in pharyngeal swab | Week 2 and Week 4 | 
| Supplemental Oxygen | Occurrence of supplemental Oxygen | Week 2 and Week 4 | 
| Mechanical Ventilation | Occurrence of Mechanical Ventilation | Week 2 and Week 4 | 
| Incidence of Treatment-Emergent Adverse Events | Occurence of Adverse events | Week 2 and Week 4 | 
| C-reactive protein (CRP) | Inflammatory Biomarker | Week 2 and Week 4 | 
| Interleukin 6 (IL-6) | Inflammatory Biomarker | Week 2 and Week 4 | 
| D-dimer | Inflammatory Biomarker | Week 2 and Week 4 | 
| Interferon gamma | type II class of interferons | Week 2 and Week 4 | 
| Ferritin | proteins | Week 2 and Week 4 | 
| TNF alpha | Inflammatory Biomarker | Week 2 and Week 4 | 
| Interleukin 1-β | Inflammatory Biomarker | Week 2 and Week 4 |