Plasma therapy (IgG) in moderate to severe COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033622
- Lead Sponsor
- ok Nayak Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <=94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes. (As per MoHFW)
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 <90% on room air. (As per MoHFW)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatmentTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method Change in oxygen saturation by pulse oximetry. All-cause mortality till day 60 <br/ ><br>Mean Number of days of hospitalization. <br/ ><br>Number of days of mechanical ventilation <br/ ><br>Proportion of patient with fever at each visit <br/ ><br>Time required to RT-PCR negative <br/ ><br>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