Covid19
Conditions
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.
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
Sponsors
Zydus Lifesciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical status of subject on a 7-point ordinal scale | Week 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supplemental Oxygen | Week 2 and Week 4 | Occurrence of supplemental Oxygen |
| Mechanical Ventilation | Week 2 and Week 4 | Occurrence of Mechanical Ventilation |
| Incidence of Treatment-Emergent Adverse Events | Week 2 and Week 4 | Occurence of Adverse events |
| C-reactive protein (CRP) | Week 2 and Week 4 | Inflammatory Biomarker |
| Interleukin 6 (IL-6) | Week 2 and Week 4 | Inflammatory Biomarker |
| PCR test | Week 2 and Week 4 | PCR for SARS-CoV-2 in pharyngeal swab |
| Interferon gamma | Week 2 and Week 4 | type II class of interferons |
| Ferritin | Week 2 and Week 4 | proteins |
| TNF alpha | Week 2 and Week 4 | Inflammatory Biomarker |
| Interleukin 1-β | Week 2 and Week 4 | Inflammatory Biomarker |
| D-dimer | Week 2 and Week 4 | Inflammatory Biomarker |
Countries
Mexico
Outcome results
None listed