COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43703

Dr Rajesh Chawla

drchawla@hotmail.com

2020-05-23

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1. Tested positive for COVID 19 by RT-PCR <br/ >2. Age > 18 years <br/ >3. Written and informed consent <br/ >4. Severe or Life threatening disease. <br/ > <br/ >1. Severe disease is defined as: (one or more are present) <br/ >i. Dyspnea with oxygen saturation â?¤ 93%, <br/ >ii. Respiratory frequency â?¥ 30/min and oxygen saturation â?¤ 93%, <br/ >iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 <br/ >iv.Infiltrates on chest X-ray > 50% within 24 to 48 hours <br/ > <br/ >2. Life-threatening disease is defined as: (one or more are present) <br/ > <br/ >i. Respiratory failure needing invasive support <br/ >ii. Sepsis, <br/ >iii. Multiple organ dysfunction or failure <br/ >

1. Known hypersensitivity to blood products <br/ >2. Receipt of Pooled Immunoglobulin in last 30 days <br/ >3. Participating in any other clinical trial <br/ >4. Contraindications to blood products <br/ >5. Pregnant or Breast feeding women <br/ >6. In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours. <br/ >7.On mechanical ventilation for more than 7 days <br/ >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.) <br/ >9. Respiratory failure caused by illness other than SARS-CoV-2. <br/ >10 . Other documented uncontrolled infection <br/ >11. Severe DIC,TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate. <br/ >12. Active intracranial bleeding. <br/ >13. Clinically significant myocardial ischemia. <br/ > <br/ >

2

Apollo Hospitals Enterprise Limited

18

90

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

100

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

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]