Phase 2
N=32
Efficacy and Safety of Itolizumab in COVID-19 Complications
Acute Respiratory Distress Syndrome · Cytokine Release Syndrome · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04475588 ↗Enrolled (actual)
32
Serious AEs
18.8%
Results posted
May 2021
Primary outcome: Primary: One-month Mortality Rate Between the Two Arms — 0; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Itolizumab IV infusion (Drug); Best supportive care (BSC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biocon Limited
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One-month Mortality Rate Between the Two Arms |
0; 3 | — |
| PRIMARY Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 |
17; 5; 19; 7; 20; 7 | — |
| PRIMARY Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) |
0; 2 | — |
| PRIMARY Reduction in Proportion of Patients on Non-invasive Ventilation |
5; 4; 0; 0; 5; 1 | — |
| PRIMARY Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 |
18; 6; 19; 7; 20; 7 | — |
| PRIMARY Reduction in Proportion of Patients- Invasive Mechanical Ventilation |
— | — |
| PRIMARY Reduction in Proportion of Patients-High Flow Nasal Oxygen |
— | — |
| PRIMARY Mean Change From Baseline in Ferritin |
-117.8; -87.05; -713.9; -209.6; -780.9; 4238 | — |
| PRIMARY Mean Change From Baseline in LDH |
-134; -44.29; -195.8; -195.2; -308.1; 155.3 | — |
| PRIMARY Mean Change From Baseline in CRP (C-reactive Protein) |
-61.69; -103.6; -81.65; -107.2; -90.99; -127.5 | — |
| PRIMARY Mean Change From Baseline D-Dimer |
-1.43; 2.30; -0.45; -0.68; -4.35; 8.54 | — |
| SECONDARY Mean Change From Baseline of Absolute Lymphocyte Count |
119.95; 45.88; 421.25; 142.60; 701.55; 10.00 | — |
| SECONDARY Biomarkers (IL-6, TNF-a) |
159.09; 162.16; 42.98; 211.52; 311.3; 310.4 | — |
| SECONDARY Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) |
126.57; 114.05; 203.50; 184.53; 283.43; 338.40 | — |
| SECONDARY Number and Percentage of Patients With Radiological Response |
9; 1 | — |
Summary
Randomized, Parallel Group, Active Controlled Trial
Eligibility Criteria
Key Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04475588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.