COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44299

Dr Aditi

hnandigala@gmail.com

2020-06-29

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Both male or female patients who signed the informed consent and aged â?¥18 years , <br/ >Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ >Patient with any of the following : <br/ >Fever â?¥36.7â?? axilla or Oral temperature â?¥ 38.0 â?? <br/ >PaO2/ FiO2: 100-300 mmHg <br/ >Respiratory Rate >24/min and SaO2 90- 93% on room air <br/ >Lung involvement confirmed with chest X-ray. <br/ >(X-ray interpretation as mentioned in ICMR guideline-bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules) <br/ >

Viral pneumonia with other viruses besides COVID-19 <br/ >Patients are not suitable for immunoglobulin therapy. <br/ >Patients with severe pneumonia defined as : RR â?¥ 30 times/min or oxygen saturation â?¤ 90% in resting state or PaO2/FiO2 â?¤ 100 mmHg or respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with prescence of other organ failure. <br/ >Patients on either immunoglobulin or hydroxychloroquine treatment <br/ >Pregnant or lactating women or other circumstances in which the investigator determined that the patient is not suitable for the clinical trial. <br/ >Participation in other studies. <br/ >

2

Virchow Biotech Private Limited

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Number of days to clinical improvement. <br/ >It is defined as no. of days from initiation of treatment day to discharge day on a six-category ordinal scale <br/ >Timepoint: 0-28 days

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

Phase 2

[{"arm_notes": "", "treatment_id": 634, "treatment_name": "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"}]