Efficacy and Safety of Itolizumab in COVID-19 Complications

• Status: Completed
• Trial end date: 2020-07-07
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, Parallel Group, Active Controlled Trial

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocon Limited
• Treatments: Anti-Bacterial Agents; Antiviral Agents; Hydroxychloroquine

Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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