Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Pegylated IFN-α2b and Standard of care: Single dose of Pegylated IFN-
α2b (1 mcg/kg) along with the
recommended standard of care
at the time of conduct of trial.
Control Intervention1
Sponsors
Zydus Research Center Cadila Healthcare Limited
Eligibility
Inclusion criteria
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 RT-PCR within 5 days of enrollment. 6. Patients with pneumonia with no signs of severe disease, respiratory rate >=24breaths/minute, SpO2 90%- 94%. 7. Illness of any duration, and at least one of the following: a. Radiographic infiltrates by imaging (chest x-ray/CT scan) b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination). 8. Women of childbearing potential must agree to use at least one primary form of contraception for the entire duration of the study (acceptable methods will be determined by the site).
Exclusion criteria
Exclusion criteria: 1. ALT/AST >5 times the upper limit of normal. 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR 3. Pregnant or breast feeding. 4. Allergy to any study medication. 5. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigatorâ??s assessment. 6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. 7. Prolong QT interval ( >450 ms).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal scale at Day 11 ± 1.Timepoint: baseline to Day 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in C-reactive protein, IL-6, D-dimer and FerritinTimepoint: screening to Day 3, Day 7 and Day 15.;Change in white blood cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and ASTTimepoint: screening to Day 3, Day 7, Day 15;Duration of hospitalization.Timepoint: Screening to Day 15;Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal scaleTimepoint: screening to Day 8, Day 11 and Day 15.;Incidence of adverse events and serious adverse events.Timepoint: Screening to Day 15 and Day 29;Occurrence and duration (days) of mechanical ventilation.Timepoint: Screening to Day 15;Occurrence and duration (days) of supplemental oxygen.Timepoint: Screening to Day 15;Proportion of subjects who are found negative to SARS-CoV-2 based on Qualitative and Quantitative (Based on the CT value) RT-PCR.Timepoint: screening to Day 7, Day 11and Day 15;Time to resolution of clinical signs and symptoms.Timepoint: Screening to Day 15 | — |
Countries
India
Contacts
Public ContactDr Balaji More
Cadila Healthcare Limited
Outcome results
None listed