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

NCT ID: NCT04480138

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2021-06-21

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pegylated Interferon-α2b

Intervention Type: DRUG

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

Standard of Care

Intervention Type: OTHER

Standard of care as per local authority

Standard of Care

Control: Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of care as per local authority

Interventions

Pegylated Interferon-α2b

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

Intervention Type: DRUG

Standard of Care

Standard of care as per local authority

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zydus Lifesciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Deven Parmar, MD

Role: STUDY_DIRECTOR

Cadila Healthcare Ltd.

Locations

Avant Sante site 2

Zapopan, Jalisco, Mexico

Avant Sante Site 1

Monterrey, , Mexico

Countries

Mexico

Other Identifiers

PEGI.20.003

Identifier Type: -

Identifier Source: org_study_id