Status:
COMPLETED
Efficacy and Safety of Itolizumab in COVID-19 Complications
Lead Sponsor:
Biocon Limited
Conditions:
Acute Respiratory Distress Syndrome
Cytokine Release Syndrome
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Randomized, Parallel Group, Active Controlled Trial
Detailed Description
This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study. All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care ...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04475588
Start Date
May 1 2020
End Date
July 7 2020
Last Update
June 14 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Mumbai, India, 400008
2
Seth GS Medical College and KEM Hospital
Mumbai, India, 400012
3
MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
New Delhi, India, 110002
4
All India Institute Of Medical Sciences
New Delhi, India, 110029