Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Intravenous Immunoglobulin (IVIG)
: 400mg /kg b.w. per day for 5 days
Control Intervention1: not applicable: not applicable
Sponsors
Lok Nayak Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects in between 18 years to 65 years 1. Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 2. Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2
Exclusion criteria
Exclusion criteria: Known hypersensitivity to immunoglobulin. History or presence of any disorder that increases the safety risk of the patient as per investigator discretion. History of DVT, PE, thromboembolic stroke or other thrombotic events. Active participant in another research treatment study. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatmentTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in oxygen saturation by pulse oximetry. All-cause mortality till day 60 Mean Number of days of hospitalization. Number of days of mechanical ventilation Proportion of patient with fever at each visit Time required to RT-PCR negative Safety (Number of AEs, SAEs, Infusion reactions) (Additional endpoints requiring investigations CT Score, Severity of pneumonia can be added â??will depend upon clinical set up.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactGovind Mawari
Maulana Azad Medical College
Outcome results
None listed