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

NCT04480138 | Terminated Phase 2 DMC

• 1 other identifier: PEGI.20.003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Change in Clinical status of subject on a 7-point ordinal scale

  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.

  Week 2

Secondary Outcomes (11)

• PCR test

  Week 2 and Week 4

• Supplemental Oxygen

  Week 2 and Week 4

• Mechanical Ventilation

  Week 2 and Week 4

• Incidence of Treatment-Emergent Adverse Events

  Week 2 and Week 4

• C-reactive protein (CRP)

  Week 2 and Week 4

Study Arms (2)

Pegylated Interferon-α2b + Standard of care

EXPERIMENTAL

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; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Pegylated Interferon-α2b DRUG

1 mcg/kg on day 1 and day 8 after safety evaluations.

Pegylated Interferon-α2b + Standard of care

Standard of Care OTHER

Standard of care as per local authority

Pegylated Interferon-α2b + Standard of care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (2)

Avant Sante site 2

Zapopan, Jalisco, Mexico

Location

Avant Sante Site 1

Monterrey, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dr Deven Parmar, MD

  Cadila Healthcare Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 21, 2020
• Study Start: August 11, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: July 12, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)