Single arm study of Itolizumab in the treatment of COVID 19 complication.

Phase 4

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/09/027941
• Lead Sponsor: Biocon Biologics India Limited

Brief Summary

Thisis a Multi-Centre, single arm, phase IV clinical trial

The study described in this protocol is designed toevaluate safety and efficacy of Itolizumab in the post marketing setting. Thisstudy will be conducted as to provide additional safety data after use ofItolizumab intravenous infusion in the treatment of cytokine release syndrome(CRS) in moderate to severe acute respiratory distress syndrome patients due toCOVID 19 administered in clinical practice as per the prescribing information.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-26
• Study Completion: 2020-10-07
• Last Update Posted: 2022-04-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Male or female adults above >18 years 2.
• Informed consent for participation in the study 3.
• Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR) 4.
• Hospitalized with ARDS due to clinical worsening of COVID-19 infection 5.
• Oxygen saturation at rest in ambient air ≤94% 6.
• Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of ≤ 200 7.
• Baseline serum ferritin level ≥ 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available.

Exclusion Criteria

• Known severe allergic reactions to monoclonal antibodies 2.
• Active tuberculosis (TB) infection 3.
• History of inadequately treated tuberculosis or latent tuberculosis 4.
• In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments 5.
• Patient on invasive mechanical ventilator support 6.
• Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months 7.
• Patient on treatment of anti-IL-6 as a part of supportive care 8.
• Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 9 Patients with known history of Hepatitis B, Hepatitis C or HIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)	Up to 1 month

Secondary Outcome Measures

Name	Time	Method
Biomarkers (IL-6 and TNF-a)	up to 1 month
Change in inflammatory markers like CRP (C-reactive protein) level, Serum Ferritin, D- dimer and LDH	Up to 1 month
Duration of hospitalization	Up to 1 month
Remission of respiratory symptoms(time to independence from oxygen therapy in days)	Up to 1 month
One-month mortality rate	Up to 1 month
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen) ratio	Up to 1 month
Remission of respiratory symptoms (time to independence from non-invasive mechanical ventilation calculated in days)	Up to 1 month
Proportion of patients without deterioration of lung function as measured by stable/ improved SpO2 without increasing FiO2	Up to 1 month
Clinical Status as improvement of 1 and 2 point on an ordinal scale	up to 1 month
Incidence, nature and severity of adverse events causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)	Up to 1 month

Trial Locations

Locations (17)

All India Institute Of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

All India Institute of Medical Sciences (AIIMS),; 🇮🇳 Raipur, CHHATTISGARH, India

Deenanath Mangeshkar Hospital; 🇮🇳 Pune, MAHARASHTRA, India

ESIC Medical College and Hospital; 🇮🇳 Faridabad, HARYANA, India

GMERS Medical College & Hospital,; 🇮🇳 Vadodara, GUJARAT, India

Government medical college and hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Kasturba Hospital of Infectious Disease; 🇮🇳 Mumbai, MAHARASHTRA, India

KR Hospital; 🇮🇳 Mysore, KARNATAKA, India

MGM Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Narayana Hrudayalaya Limited; 🇮🇳 Bangalore, KARNATAKA, India

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All India Institute Of Medical Sciences

🇮🇳Khordha, ORISSA, India

Dr Manoj Kumar Panigrahi

Principal investigator

9438884282

pulmed_manoj@aiimsbhubaneswar.edu.in