COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48319

Dr Poonam kumari

drpoonam1981@gmail.com

2020-10-09

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Age 18 to 60 years <br/ >2. Virological diagnosis of SARS-CoV2 infection <br/ > (PCR) <br/ >3. Patients who are in moderate ARDS following <br/ > COVID-19 infection, as defined by PaO2/FiO2 <br/ > ratio of <200, or more than 25% <br/ > deterioration from the immediate previous <br/ > value within 24hrs in patient having <br/ > po2/fio2 >200. <br/ >4. Baseline serum ferritin level â?¥400ng/mL or <br/ > IL-6 levels greater than 4 times the upper <br/ > limit of normal (ULN) would be included. <br/ >

1. Known case of severe allergic reactions to <br/ > monoclonal antibodies <br/ >2. Active tuberculosis (TB) infection <br/ >3. History of inadequately treated tuberculosis <br/ > or latent tuberculosis <br/ >4. Have received oral anti-rejection or immune- <br/ > suppressive drugs within the past 6 months <br/ >5. Pregnant or breastfeeding, or positive <br/ > pregnancy test in a pre-dose examination <br/ >6. Patients with known history of Hepatitis <br/ > B, Hepatitis C or HIV <br/ >7. Absolute Neutrophils count (ANC) <1000 / mm3 <br/ >8. Platelets <50,000 / mm3 <br/ >9. Absolute Lymphocyte count (ALC): <500/mm3 <br/ >10. Very severe ARDS Pao2/Fio2â?¤100 with PEEPâ?¥5 <br/ >11. ARDS due to others secondary infection/ <br/ > bacterial sepsis (High procalcitonin value) <br/ >12. Those patient who will be recruited for <br/ > another study <br/ >

2

AIIMS Patna

18

60

India

Severe disease at enrollment

6: Severe disease at enrollment

50

P/F ratio [ baseline; during treatment before every dose after 12 hr post dose;] daily for one week;14th dayTimepoint: 3 month

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 691, "treatment_name": "Itolizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}]