Efficacy and Safety of Itolizumab in COVID-19 Complications
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J70- Respiratory conditions due to other external agents
- Registration Number
- CTRI/2020/05/024959
- Lead Sponsor
- Biocon Biologics India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Male or female adults above 18 years (not tested in children yet)
2. Informed consent for participation in the study
3. Virological diagnosis of SARS-CoV2 infection (PCR)
4. Hospitalized due to clinical/instrumental diagnosis 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 or
more than 25% detoriation from the immediate previous value.
1. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 one month mortality rate <br/ ><br>2 Proportion of pts with deterioration of lung function as measured by <br/ ><br>â?¢ Stable SpO2; PaO2 without increasing FiO2 <br/ ><br>3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation <br/ ><br>4 Reduction in proportion of pts who need <br/ ><br>â?¢ NIV <br/ ><br>â?¢ IMV <br/ ><br>â?¢ HFNO <br/ ><br>5 Time of duration of mechanical ventilation, for pts needing intubation <br/ ><br>6 Change in inflammatory markers CRP, d-Dimer, ferritin <br/ ><br> <br/ ><br>Timepoint: up to One-month <br/ ><br>
- Secondary Outcome Measures
Name Time Method Biomarkers (IL-6, TNF-a)Timepoint: up to One-month;Duration of hospitalizationTimepoint: up to One-month;Lymphocyte countTimepoint: up to One-month;PaO2 / FiO2 ratioTimepoint: up to One-month;Radiological responseTimepoint: up to One-month;Remission of respiratory symptomsTimepoint: up to One-month;Treatment-related side effects as assessed by CTCAETimepoint: up to One-month