Acute Respiratory Distress Syndrome, Covid19, Cytokine Release Syndrome
Conditions
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 + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS. As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.
Interventions
DRUGItolizumab IV infusion
First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks. BSC: similar to Arm B
DRUGBest supportive care (BSC)
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
Sponsors
Biocon Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline D-Dimer | Day 7, Day 14, Day 21 & Day 30 | — |
| Reduction in Proportion of Patients-High Flow Nasal Oxygen | Day7 ,Day 14 ,Day 21, Day 30 | Patient improved from High Flow Nasal Oxygen over time from baseline. |
| Mean Change From Baseline in Ferritin | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in Ferritin |
| Mean Change From Baseline in LDH | Day 7, Day14, Day 21 and Day 30. | Mean Change from Baseline in LDH |
| Mean Change From Baseline in CRP (C-reactive Protein) | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in CRP |
| One-month Mortality Rate Between the Two Arms | One-month | 1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30 |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 7, Day 14, Day 21 & Day 30 | Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 \> 92% |
| Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | Day 30 | Number of patients needing Intubation/IMV post treatment |
| Reduction in Proportion of Patients on Non-invasive Ventilation | Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30 | Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time |
| Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 7, Day14, Day 21 & Day30 | Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with \> 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen). |
| Reduction in Proportion of Patients- Invasive Mechanical Ventilation | Day7, Day14, Day21 & Day 30 | Patient improved from invasive ventilation over time from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers (IL-6, TNF-a) | Pre and Post 1st dose; Pre and Post 2nd dose | Mean values of Pre and Post 1st and 2nd dose are shown |
| Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Baseline, Day 7, Day 14, Day 21 & Day 30 | Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) |
| Number and Percentage of Patients With Radiological Response | up to Day 30 | Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment |
| Mean Change From Baseline of Absolute Lymphocyte Count | day 7, day 14 ,day 21 & day 30 | Mean change From baseline in Lymphocyte count |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A - Itolizumab + BSC IItolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc | 20 |
| Arm B - Best Supportive Care (BSC) Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Arm B - Best Supportive Care (BSC) | Total | Arm A - Itolizumab + BSC |
|---|---|---|---|
| Age, Continuous | 48.30 Years STANDARD_DEVIATION 14.62 | 49.13 Years STANDARD_DEVIATION 13.21 | 49.55 Years STANDARD_DEVIATION 12.49 |
| Race/Ethnicity, Customized Asian | 10 Participants | 30 Participants | 20 Participants |
| Region of Enrollment India | 10 participants | 30 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 26 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 22 | 3 / 10 |
| other Total, other adverse events | 18 / 22 | 4 / 10 |
| serious Total, serious adverse events | 3 / 22 | 3 / 10 |
Outcome results
Primary
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
Number of patients needing Intubation/IMV post treatment
Time frame: Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A - Itolizumab + BSC | Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | 0 participants |
| Arm B - Best Supportive Care (BSC) | Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | 2 participants |
Primary
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with \> 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen).
Time frame: Day 7, Day14, Day 21 & Day30
Population: Patients improved/ weaned off O2, the observation was carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 14 | 19 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 7 | 18 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 21 | 20 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 30/EOS | 20 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 30/EOS | 7 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 14 | 7 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 21 | 7 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 7 | 6 participants |
Primary
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 \> 92%
Time frame: Day 7, Day 14, Day 21 & Day 30
Population: Patients improved/ weaned off O2, the observation was carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 30/EOS | 20 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 14 | 19 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 7 | 17 participants |
| Arm A - Itolizumab + BSC | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 21 | 20 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 30/EOS | 7 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 21 | 7 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 7 | 5 participants |
| Arm B - Best Supportive Care (BSC) | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 14 | 7 participants |
Primary
Mean Change From Baseline D-Dimer
Time frame: Day 7, Day 14, Day 21 & Day 30
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean Change From Baseline D-Dimer | Day 7 | -1.43 µg/ml | Standard Deviation 6.31 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline D-Dimer | Day 14 | -0.45 µg/ml | Standard Deviation 6.39 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline D-Dimer | Day 21 | -4.35 µg/ml | Standard Deviation 6.13 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline D-Dimer | Day 30 | -2.63 µg/ml | Standard Deviation 2.43 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline D-Dimer | Day 30 | -0.35 µg/ml | Standard Deviation 0.08 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline D-Dimer | Day 7 | 2.30 µg/ml | Standard Deviation 6.67 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline D-Dimer | Day 21 | 8.54 µg/ml | Standard Deviation 14.4 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline D-Dimer | Day 14 | -0.68 µg/ml | Standard Deviation 0.79 |
Primary
Mean Change From Baseline in CRP (C-reactive Protein)
Mean Change from Baseline in CRP
Time frame: Day 7, Day 14, Day 21 & Day 30
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean Change From Baseline in CRP (C-reactive Protein) | Day 7 | -61.69 mg/L | Standard Deviation 81.86 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in CRP (C-reactive Protein) | Day 14 | -81.65 mg/L | Standard Deviation 74.71 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in CRP (C-reactive Protein) | Day 21 | -90.99 mg/L | Standard Deviation 81.97 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in CRP (C-reactive Protein) | Day 30/EOS | -103.2 mg/L | Standard Deviation 100.53 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in CRP (C-reactive Protein) | Day 14 | -107.2 mg/L | Standard Deviation 104.66 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in CRP (C-reactive Protein) | Day 7 | -103.6 mg/L | Standard Deviation 87.48 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in CRP (C-reactive Protein) | Day 21 | -127.5 mg/L | Standard Deviation 124.04 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in CRP (C-reactive Protein) | Day 30/EOS | -127.6 mg/L | Standard Deviation 59.68 |
Primary
Mean Change From Baseline in Ferritin
Mean Change from Baseline in Ferritin
Time frame: Day 7, Day 14, Day 21 & Day 30
Population: only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean Change From Baseline in Ferritin | Day 7 | -117.8 ng/mL | Standard Deviation 1477 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in Ferritin | Day 14 | -713.9 ng/mL | Standard Deviation 693.68 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in Ferritin | Day 21 | -780.9 ng/mL | Standard Deviation 630.61 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in Ferritin | Day 30/EOS | -479.3 ng/mL | Standard Deviation 620.95 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in Ferritin | Day 30/EOS | -234.4 ng/mL | Standard Deviation 405.67 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in Ferritin | Day 7 | -87.05 ng/mL | Standard Deviation 140.99 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in Ferritin | Day 21 | 4238 ng/mL | Standard Deviation 8319 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in Ferritin | Day 14 | -209.6 ng/mL | Standard Deviation 177.33 |
Primary
Mean Change From Baseline in LDH
Mean Change from Baseline in LDH
Time frame: Day 7, Day14, Day 21 and Day 30.
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean Change From Baseline in LDH | Day 7 | -134 U/L | Standard Deviation 174.67 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in LDH | Day 21 | -308.1 U/L | Standard Deviation 202.76 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in LDH | Day 14 | -195.8 U/L | Standard Deviation 291.94 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline in LDH | Day 30/EOS | -212.7 U/L | Standard Deviation 188.48 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in LDH | Day 14 | -195.2 U/L | Standard Deviation 119.93 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in LDH | Day 7 | -44.29 U/L | Standard Deviation 176.85 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in LDH | Day 30/EOS | -97 U/L | Standard Deviation 89.1 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline in LDH | Day 21 | 155.3 U/L | Standard Deviation 736.47 |
Primary
One-month Mortality Rate Between the Two Arms
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Time frame: One-month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A - Itolizumab + BSC | One-month Mortality Rate Between the Two Arms | 0 participants |
| Arm B - Best Supportive Care (BSC) | One-month Mortality Rate Between the Two Arms | 3 participants |
Primary
Reduction in Proportion of Patients-High Flow Nasal Oxygen
Patient improved from High Flow Nasal Oxygen over time from baseline.
Time frame: Day7 ,Day 14 ,Day 21, Day 30
Population: There were no patients on High Flow Nasal Oxygen at baseline
Primary
Reduction in Proportion of Patients- Invasive Mechanical Ventilation
Patient improved from invasive ventilation over time from baseline.
Time frame: Day7, Day14, Day21 & Day 30
Population: There were no patients on invasive mechanical ventilation at baseline
Primary
Reduction in Proportion of Patients on Non-invasive Ventilation
Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time
Time frame: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A - Itolizumab + BSC | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 7 | 0 participants |
| Arm A - Itolizumab + BSC | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 21 | 5 participants |
| Arm A - Itolizumab + BSC | Reduction in Proportion of Patients on Non-invasive Ventilation | Baseline (Day 1) | 5 participants |
| Arm A - Itolizumab + BSC | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 30/EOS | 5 participants |
| Arm A - Itolizumab + BSC | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 14 | 5 participants |
| Arm B - Best Supportive Care (BSC) | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 30/EOS | 1 participants |
| Arm B - Best Supportive Care (BSC) | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 14 | 1 participants |
| Arm B - Best Supportive Care (BSC) | Reduction in Proportion of Patients on Non-invasive Ventilation | Baseline (Day 1) | 4 participants |
| Arm B - Best Supportive Care (BSC) | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 21 | 1 participants |
| Arm B - Best Supportive Care (BSC) | Reduction in Proportion of Patients on Non-invasive Ventilation | Day 7 | 0 participants |
Secondary
Biomarkers (IL-6, TNF-a)
Mean values of Pre and Post 1st and 2nd dose are shown
Time frame: Pre and Post 1st dose; Pre and Post 2nd dose
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | IL-6 (Post 1st Dose) | 42.98 pg/ml | Standard Deviation 52.9 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | TNF-a (Pre 1st Dose) | 43.64 pg/ml | Standard Deviation 72.9 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | IL-6 (Post 2nd Dose) | 91.0 pg/ml | Standard Deviation 245.6 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | TNF-a (Post 1st Dose) | 8.87 pg/ml | Standard Deviation 12.3 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | IL-6 (Pre 1st Dose) | 159.09 pg/ml | Standard Deviation 293 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | TNF-a (Pre 2nd Dose | 68.0 pg/ml | Standard Deviation 109.5 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | TNF-a (Post 2nd Dose) | 50.1 pg/ml | Standard Deviation 140.2 |
| Arm A - Itolizumab + BSC | Biomarkers (IL-6, TNF-a) | IL-6 (Pre 2nd Dose) | 311.3 pg/ml | Standard Deviation 660.4 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | TNF-a (Post 2nd Dose) | 185.0 pg/ml | Standard Deviation 275.8 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | IL-6 (Pre 2nd Dose) | 310.4 pg/ml | Standard Deviation 528.2 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | IL-6 (Post 2nd Dose) | 316.8 pg/ml | Standard Deviation 373.7 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | TNF-a (Pre 2nd Dose | 107.8 pg/ml | Standard Deviation 175.3 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | IL-6 (Pre 1st Dose) | 162.16 pg/ml | Standard Deviation 185.9 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | TNF-a (Pre 1st Dose) | 11.26 pg/ml | Standard Deviation 13.6 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | TNF-a (Post 1st Dose) | 39.19 pg/ml | Standard Deviation 104.5 |
| Arm B - Best Supportive Care (BSC) | Biomarkers (IL-6, TNF-a) | IL-6 (Post 1st Dose) | 211.52 pg/ml | Standard Deviation 297.2 |
Secondary
Mean Change From Baseline of Absolute Lymphocyte Count
Mean change From baseline in Lymphocyte count
Time frame: day 7, day 14 ,day 21 & day 30
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean Change From Baseline of Absolute Lymphocyte Count | Day 7 | 119.95 cells/mm^3 | Standard Deviation 478.63 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline of Absolute Lymphocyte Count | Day 14 | 421.25 cells/mm^3 | Standard Deviation 569.71 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline of Absolute Lymphocyte Count | Day 21 | 701.55 cells/mm^3 | Standard Deviation 625.34 |
| Arm A - Itolizumab + BSC | Mean Change From Baseline of Absolute Lymphocyte Count | Day 30/EOS | 719.75 cells/mm^3 | Standard Deviation 1004 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline of Absolute Lymphocyte Count | Day 30/EOS | 85.00 cells/mm^3 | Standard Deviation 601.04 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline of Absolute Lymphocyte Count | Day 7 | 45.88 cells/mm^3 | Standard Deviation 762.37 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline of Absolute Lymphocyte Count | Day 21 | 10.00 cells/mm^3 | Standard Deviation 930.16 |
| Arm B - Best Supportive Care (BSC) | Mean Change From Baseline of Absolute Lymphocyte Count | Day 14 | 142.60 cells/mm^3 | Standard Deviation 731.94 |
Secondary
Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)
Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)
Time frame: Baseline, Day 7, Day 14, Day 21 & Day 30
Population: Only observed values were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A - Itolizumab + BSC | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 7 | 203.50 Ratio | Standard Deviation 95.51 |
| Arm A - Itolizumab + BSC | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Baseline/Day 1 | 126.57 Ratio | Standard Deviation 38.31 |
| Arm A - Itolizumab + BSC | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 14 | 283.43 Ratio | Standard Deviation 104.26 |
| Arm A - Itolizumab + BSC | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 21 | 350.25 Ratio | Standard Deviation 70.36 |
| Arm A - Itolizumab + BSC | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 30/EOS | 397.67 Ratio | Standard Deviation 15.63 |
| Arm B - Best Supportive Care (BSC) | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 14 | 338.40 Ratio | Standard Deviation 42.57 |
| Arm B - Best Supportive Care (BSC) | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 21 | 398.33 Ratio | Standard Deviation 24.01 |
| Arm B - Best Supportive Care (BSC) | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Baseline/Day 1 | 114.05 Ratio | Standard Deviation 30.93 |
| Arm B - Best Supportive Care (BSC) | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Day 7 | 184.53 Ratio | Standard Deviation 95.51 |
Secondary
Number and Percentage of Patients With Radiological Response
Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment
Time frame: up to Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A - Itolizumab + BSC | Number and Percentage of Patients With Radiological Response | 9 Participants |
| Arm B - Best Supportive Care (BSC) | Number and Percentage of Patients With Radiological Response | 1 Participants |