COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04475588

Biocon Limited

Not reported

2020-07-17

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

key inclusion criteria: male or female adults above 18 years (not tested in children yet) informed consent for participation in the study virological diagnosis of sars-cov2 infection (pcr) hospitalized due to clinical/instrumental diagnosis of covid-19 infection oxygen saturation at rest in ambient air ≤94% patients who are in moderate to severe ards as defined by pao2/fio2 ratio of < 200 key

known severe allergic reactions to monoclonal antibodies active tuberculosis (tb) infection history of inadequately treated tuberculosis or latent tuberculosis in the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments have received oral anti-rejection or immune-suppressive drugs within the past 6 months participating in other drug clinical trials (participation in covid-19 anti-viral trials may be permitted if approved by medical monitor) pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination patients with known history of hepatitis b, hepatitis c or hiv absolute neutrophils count (anc) <1000 / mm3 platelets <50,000 / mm3 absolute lymphocyte count (alc): <500/mm3

2

Biocon Limited

18

99

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

32

Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV);Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2;Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2;Mean Change From Baseline D-Dimer;Mean Change From Baseline in CRP (C-reactive Protein);Mean Change From Baseline in Ferritin;Mean Change From Baseline in LDH;One-month Mortality Rate Between the Two Arms;Reduction in Proportion of Patients-High Flow Nasal Oxygen;Reduction in Proportion of Patients- Invasive Mechanical Ventilation;Reduction in Proportion of Patients on Non-invasive Ventilation

None

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"}]