COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42878

Sivakumar Vaidyanathan

subramanian.l101@biocon.com

2020-05-01

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Male or female adults above 18 years (not tested in children yet) <br/ >2. Informed consent for participation in the study <br/ >3. Virological diagnosis of SARS-CoV2 infection (PCR) <br/ >4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection <br/ >5. Oxygen saturation at rest in ambient air â?¤94% <br/ >6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200 or <br/ >more than 25% detoriation from the immediate previous value. <br/ >

1. Known severe allergic reactions to monoclonal antibodies <br/ >2. Active tuberculosis (TB) infection <br/ >3. History of inadequately treated tuberculosis or latent tuberculosis <br/ >4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments <br/ >5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months <br/ >6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) <br/ >7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >8. Patients with known history of Hepatitis B, Hepatitis C or HIV <br/ >9. Absolute Neutrophils count (ANC) <1000 / mm3 <br/ >10. Platelets <50,000 / mm3 <br/ >11. Absolute Lymphocyte count (ALC): <500/mm3 <br/ > <br/ >

2

Biocon Biologics India Limited

18

100

India

Severe disease at enrollment

6: Severe disease at enrollment

30

1 one month mortality rate <br/ >2 Proportion of pts with deterioration of lung function as measured by <br/ >â?¢ Stable SpO2; PaO2 without increasing FiO2 <br/ >3 Reduction of endotracheal intubation rate; measured as rate of pts needing intubation <br/ >4 Reduction in proportion of pts who need <br/ >â?¢ NIV <br/ >â?¢ IMV <br/ >â?¢ HFNO <br/ >5 Time of duration of mechanical ventilation; for pts needing intubation <br/ >6 Change in inflammatory markers CRP; d-Dimer; ferritin <br/ > <br/ >Timepoint: up to One-month <br/ >

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

Phase 2

[{"arm_notes": "", "treatment_id": 691, "treatment_name": "Itolizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]