COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44170

Anirban Roychowdhury

Anirban.roychowdhuryh@bharatserums.com

2020-06-08

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1. Hospitalized adult aged >18-65 years inclusive <br/ >2. Confirmed COVID-19 infection (RT â??PCR-test) <br/ >3. Symptoms of mild or moderate ARDS <br/ > <br/ >(Ref: MoHFW/ ICMR Revised guidelines on clinical management of COVID-19- 31Mar2020)

1. Patients with history of HIV/HCV/HBV positive or immunocompromised or TB <br/ >2. Patients with significant co-morbidities at screening, as judged by the treating Investigator <br/ >3. Moribund state in which death is perceived to be imminent (â?¤48 hours) <br/ >4. Known hypersensitivity to any component of the investigational product <br/ >5. Pregnant or nursing (lactating) women. <br/ >6. Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19). <br/ >7. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra). <br/ >8. Participation in any other clinical study

2

Bharat Serums and Vaccines ltd

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

1. Number of days of use of Mechanical Ventilation <br/ >2. Change from baseline in PF ratio (PaO2/FiO2) <br/ >Timepoint: 1. Number of days of use of Mechanical Ventilation <br/ >2. Change from baseline in PF ratio (PaO2/FiO2) <br/ >

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

Phase 3

[{"arm_notes": "", "treatment_id": 1328, "treatment_name": "Ulinastatin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]