TerminatedNCT04480138Updated Jul 12, 2022

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

A Phase 2 interventional study of Pegylated Interferon-α2b and Standard of Care in Covid19, sponsored by Zydus Lifesciences Limited. Terminated at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Zydus Lifesciences Limited · Phase 2, Interventional, and Treatment

Why this study was terminated

Due to non availability of eligible subjects and slow recruitment

Phase: Phase 2
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Covid19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Zydus Lifesciences Limited is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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:
1. Radiographic infiltrates by imaging (chest x-ray)
2. 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

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).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 7 participants (actual)

Study arms

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.
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.
Other: Standard of Care

Interventions

DrugPegylated Interferon-α2b
1 mcg/kg on day 1 and day 8 after safety evaluations.
OtherStandard of Care
Standard of care as per local authority

What researchers measure

Primary outcomes

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.
Time frame: Week 2

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04480138
Lead sponsor: Zydus Lifesciences Limited
Responsible party: Sponsor
First posted: Jul 21, 2020
Start date: Aug 11, 2020
Primary completion: Jun 21, 2021
Completion: Jun 21, 2021
Last update: Jul 12, 2022

Study contacts

Dr Deven Parmar, MD

study director · Cadila Healthcare Ltd.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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