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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Other: Standard of Care; Drug: Pegylated Interferon-α2b

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: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Monterrey, Mexico
    • Avant Sante Site 1
  • Jalisco
    • Zapopan, Jalisco, Mexico
      • Avant Sante site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: Standard of Care; Standard of care as per local authority; Drug: Pegylated Interferon-α2b; 1 mcg/kg on day 1 and day 8 after safety evaluations.
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zydus Lifesciences Limited
• Investigators: Study Director: Dr Deven Parmar, MD, Cadila Healthcare Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons
• Other Study ID Numbers: PEGI.20.003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No