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

Zydus Lifesciences

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Pegylated Interferon-α2b; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04480138

PEGI.20.003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Pegylated Interferon-α2b + Standard of care

Experimental group

Description:

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.

Treatment:

Drug: Pegylated Interferon-α2b

Other: Standard of Care

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care