Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Convalescent plasma: Convalescent plasma, two doses of 200 mL each.
Control Intervention1: Routine standard of care treatment for COVID 19 disease: Routine standard of care treatment fo
Sponsors
Apollo Hospitals Enterprise Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Tested positive for COVID 19 by RT-PCR 2. Age > 18 years 3. Written and informed consent 4. Severe or Life threatening disease. 1. Severe disease is defined as: (one or more are present) i. Dyspnea with oxygen saturation ii. Respiratory frequency >= 30/min and oxygen saturation iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio iv.Infiltrates on chest X-ray > 50% within 24 to 48 hours 2. Life-threatening disease is defined as: (one or more are present) i. Respiratory failure needing invasive support ii. Sepsis, iii. Multiple organ dysfunction or failure
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to blood products 2. Receipt of Pooled Immunoglobulin in last 30 days 3. Participating in any other clinical trial 4. Contraindications to blood products 5. Pregnant or Breast feeding women 6. In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours. 7.On mechanical ventilation for more than 7 days 8.Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g. stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.) 9. Respiratory failure caused by illness other than SARS-CoV-2. 10 . Other documented uncontrolled infection 11. Severe DIC,TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate. 12. Active intracranial bleeding. 13. Clinically significant myocardial ischemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite measure of the i. All-cause Mortality at 28 days ii. Improvement of SOFA score Post transfusion Timepoint: 28 days from intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| i.Time to symptom resolution a. Fever b. Shortness of Breath c. Fatigue ii. Length of hospital stay. iii. Change in oxygen requirement post transfusion. iv.Decreased duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive /HFNC v. Radiological improvement vii. Adverse events (AE) associated with transfusion ix. Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusion x.Need of Vasopressor use Timepoint: 1,3,7,14,28 days | — |
Countries
India
Contacts
Public ContactDr Rajesh Chawla
Indraprastha Apollo Hospitals
Outcome results
None listed