Study to Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications

Phase 2

Completed

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/05/025328

Lead Sponsor: Apollo Hospitals Enterprise Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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 <= 93%,

ii. Respiratory frequency >= 30/min and oxygen saturation <= 93%,

iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a composite measure of the <br/ ><br> <br/ ><br>i. All-cause Mortality at 28 days <br/ ><br>ii. Improvement of SOFA score Post transfusion <br/ ><br> <br/ ><br>Timepoint: 28 days from intervention

Secondary Outcome Measures

Name	Time	Method
i.Time to symptom resolution a. Fever b. Shortness of Breath c. Fatigue <br/ ><br>ii. Length of hospital stay. <br/ ><br>iii. Change in oxygen requirement post transfusion. <br/ ><br>iv.Decreased duration of respiratory support required <br/ ><br>a. Duration of Invasive Mechanical Ventilation <br/ ><br>b. Duration of Non-Invasive /HFNC <br/ ><br>v. Radiological improvement <br/ ><br>vii. Adverse events (AE) associated with transfusion <br/ ><br>ix. Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusion <br/ ><br>x.Need of Vasopressor use <br/ ><br>Timepoint: 1,3,7,14,28 days