COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56002

Govind Mawari

drmraduldaga@gmail.com

2021-05-14

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Male or female subjects in between 18 years to 65 years <br/ >1. Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 â?¤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes. (As per MoHFW) <br/ >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) <br/ >

Known hypersensitivity to immunoglobulin. <br/ >History or presence of any disorder that increases the safety risk of the patient as per investigator discretion. <br/ >History of DVT, PE, thromboembolic stroke or other thrombotic events. <br/ >Active participant in another research treatment study. <br/ >Pregnancy. <br/ >

2

Lok Nayak Hospital

18

100

India

Severe disease at enrollment

6: Severe disease at enrollment

60

Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatmentTimepoint: 3 months

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

Not reported

[{"arm_notes": "Intravenous Immunoglobulin (IVIG)", "treatment_id": 597, "treatment_name": "Human immunoglobulin", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]