Efficacy and Safety of Itolizumab in COVID-19 Complications

Phase 2

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J70||Respiratory conditions due to other external agents,

Brief Summary: This is a Multi-Centric, Open label, Two ArmRandomized, Pivotal Phase 2 Study.

All eligible patientsentering into the study will be randomized in 2:1 ratio to receive thetreatment A (Best supportive care + Itolizumab) / B (Best supportive care)respectively. Each patient will undergo the treatment based on their assignedtreatment for a month along with battery of tests that includes, but notlimited to, cytokines and chemokine, along with daily recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine;T.Bilirubin; morning Vitals â€“pulse, BP, RR; Temperature (highest temperature ofthe day),PaO2/FiO2, MAP, GCS.

As Itolizumab is aninvestigational drug, the benefit to COVID-19 patients experiencingcomplications such as Cytokine Release Syndrome is not known. However, findingsfrom this study may be beneficial to the society at a large at the National andInternational Level.

Recruitment & Eligibility

Inclusion Criteria

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

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.
Have received oral anti-rejection or immune-suppressive drugs within the past 6 months 6.
Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) 7.
Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 8.
Patients with known history of Hepatitis B, Hepatitis C or HIV 9.
Absolute Neutrophils count (ANC) <1000 / mm3 10.
Platelets <50,000 / mm3 11.
Absolute Lymphocyte count (ALC): <500/mm3.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Biomarkers (IL-6, TNF-a)	up to One-month
PaO2 / FiO2 ratio	up to One-month
Treatment-related side effects as assessed by CTCAE	up to One-month
Radiological response	up to One-month
Duration of hospitalization	up to One-month
Lymphocyte count	up to One-month
Remission of respiratory symptoms	up to One-month

Locations (4): All India Institute Of Medical Sciences,
🇮🇳
Delhi, DELHI, India
MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
🇮🇳
Delhi, DELHI, India
Seth GS Medical College and KEM Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
🇮🇳
Mumbai, MAHARASHTRA, India
All India Institute Of Medical Sciences,
🇮🇳Delhi, DELHI, India
Dr Anjan Trikha
Principal investigator
9810977901
anjantrikha@hotmail.com