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.
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.
Drug: Pegylated Interferon-α2b
1 mcg/kg on day 1 and day 8 after safety evaluations.
Other: Standard of Care
Standard of care as per local authority
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).
Avant Sante site 2
Zapopan, Jalisco, Mexico
Avant Sante Site 1
Monterrey, Mexico
Dr Deven Parmar, MD, Study Director
Cadila Healthcare Ltd.