Status:
TERMINATED
Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Lead Sponsor:
Zydus Lifesciences Limited
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04480138
Start Date
August 11 2020
End Date
June 21 2021
Last Update
July 12 2022
Active Locations (2)
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1
Avant Sante site 2
Zapopan, Jalisco, Mexico
2
Avant Sante Site 1
Monterrey, Mexico