Trial Outcomes & Findings for Efficacy and Safety of Itolizumab in COVID-19 Complications (NCT NCT04475588)
NCT ID: NCT04475588
Last Updated: 2021-06-14
Results Overview
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
One-month
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
Arm A - Itolizumab + BSC
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
10
|
|
Overall Study
COMPLETED
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A - Itolizumab + BSC
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Itolizumab in COVID-19 Complications
Baseline characteristics by cohort
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.55 Years
STANDARD_DEVIATION 12.49 • n=5 Participants
|
48.30 Years
STANDARD_DEVIATION 14.62 • n=7 Participants
|
49.13 Years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One-month1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
One-month Mortality Rate Between the Two Arms
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21 & Day 30Population: Patients improved/ weaned off O2, the observation was carried forward
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%
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 14
|
19 participants
|
7 participants
|
|
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 7
|
17 participants
|
5 participants
|
|
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 21
|
20 participants
|
7 participants
|
|
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 30/EOS
|
20 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Day 30Number of patients needing Intubation/IMV post treatment
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30Reduction 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
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 14
|
5 participants
|
1 participants
|
|
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 21
|
5 participants
|
1 participants
|
|
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 30/EOS
|
5 participants
|
1 participants
|
|
Reduction in Proportion of Patients on Non-invasive Ventilation
Baseline (Day 1)
|
5 participants
|
4 participants
|
|
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 7
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 7, Day14, Day 21 & Day30Population: Patients improved/ weaned off O2, the observation was carried forward.
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).
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 7
|
18 participants
|
6 participants
|
|
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 14
|
19 participants
|
7 participants
|
|
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 21
|
20 participants
|
7 participants
|
|
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 30/EOS
|
20 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Day7, Day14, Day21 & Day 30Population: There were no patients on invasive mechanical ventilation at baseline
Patient improved from invasive ventilation over time from baseline.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day7 ,Day 14 ,Day 21, Day 30Population: There were no patients on High Flow Nasal Oxygen at baseline
Patient improved from High Flow Nasal Oxygen over time from baseline.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21 & Day 30Population: only "observed values" were used.
Mean Change from Baseline in Ferritin
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Mean Change From Baseline in Ferritin
Day 7
|
-117.8 ng/mL
Standard Deviation 1477.0
|
-87.05 ng/mL
Standard Deviation 140.99
|
|
Mean Change From Baseline in Ferritin
Day 14
|
-713.9 ng/mL
Standard Deviation 693.68
|
-209.6 ng/mL
Standard Deviation 177.33
|
|
Mean Change From Baseline in Ferritin
Day 21
|
-780.9 ng/mL
Standard Deviation 630.61
|
4238 ng/mL
Standard Deviation 8319.0
|
|
Mean Change From Baseline in Ferritin
Day 30/EOS
|
-479.3 ng/mL
Standard Deviation 620.95
|
-234.4 ng/mL
Standard Deviation 405.67
|
PRIMARY outcome
Timeframe: Day 7, Day14, Day 21 and Day 30.Population: Only "observed values" were used.
Mean Change from Baseline in LDH
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Mean Change From Baseline in LDH
Day 21
|
-308.1 U/L
Standard Deviation 202.76
|
155.3 U/L
Standard Deviation 736.47
|
|
Mean Change From Baseline in LDH
Day 30/EOS
|
-212.7 U/L
Standard Deviation 188.48
|
-97 U/L
Standard Deviation 89.1
|
|
Mean Change From Baseline in LDH
Day 7
|
-134 U/L
Standard Deviation 174.67
|
-44.29 U/L
Standard Deviation 176.85
|
|
Mean Change From Baseline in LDH
Day 14
|
-195.8 U/L
Standard Deviation 291.94
|
-195.2 U/L
Standard Deviation 119.93
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21 & Day 30Population: Only "observed values" were used.
Mean Change from Baseline in CRP
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Mean Change From Baseline in CRP (C-reactive Protein)
Day 7
|
-61.69 mg/L
Standard Deviation 81.86
|
-103.6 mg/L
Standard Deviation 87.48
|
|
Mean Change From Baseline in CRP (C-reactive Protein)
Day 14
|
-81.65 mg/L
Standard Deviation 74.71
|
-107.2 mg/L
Standard Deviation 104.66
|
|
Mean Change From Baseline in CRP (C-reactive Protein)
Day 21
|
-90.99 mg/L
Standard Deviation 81.97
|
-127.5 mg/L
Standard Deviation 124.04
|
|
Mean Change From Baseline in CRP (C-reactive Protein)
Day 30/EOS
|
-103.2 mg/L
Standard Deviation 100.53
|
-127.6 mg/L
Standard Deviation 59.68
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21 & Day 30Population: Only "observed values" were used.
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Mean Change From Baseline D-Dimer
Day 7
|
-1.43 µg/ml
Standard Deviation 6.31
|
2.30 µg/ml
Standard Deviation 6.67
|
|
Mean Change From Baseline D-Dimer
Day 14
|
-0.45 µg/ml
Standard Deviation 6.39
|
-0.68 µg/ml
Standard Deviation 0.79
|
|
Mean Change From Baseline D-Dimer
Day 21
|
-4.35 µg/ml
Standard Deviation 6.13
|
8.54 µg/ml
Standard Deviation 14.40
|
|
Mean Change From Baseline D-Dimer
Day 30
|
-2.63 µg/ml
Standard Deviation 2.43
|
-0.35 µg/ml
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: day 7, day 14 ,day 21 & day 30Population: Only "observed values" were used.
Mean change From baseline in Lymphocyte count
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Mean Change From Baseline of Absolute Lymphocyte Count
Day 7
|
119.95 cells/mm^3
Standard Deviation 478.63
|
45.88 cells/mm^3
Standard Deviation 762.37
|
|
Mean Change From Baseline of Absolute Lymphocyte Count
Day 14
|
421.25 cells/mm^3
Standard Deviation 569.71
|
142.60 cells/mm^3
Standard Deviation 731.94
|
|
Mean Change From Baseline of Absolute Lymphocyte Count
Day 21
|
701.55 cells/mm^3
Standard Deviation 625.34
|
10.00 cells/mm^3
Standard Deviation 930.16
|
|
Mean Change From Baseline of Absolute Lymphocyte Count
Day 30/EOS
|
719.75 cells/mm^3
Standard Deviation 1004.0
|
85.00 cells/mm^3
Standard Deviation 601.04
|
SECONDARY outcome
Timeframe: Pre and Post 1st dose; Pre and Post 2nd dosePopulation: Only "observed values" were used.
Mean values of Pre and Post 1st and 2nd dose are shown
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=18 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Biomarkers (IL-6, TNF-a)
IL-6 (Post 1st Dose)
|
42.98 pg/ml
Standard Deviation 52.9
|
211.52 pg/ml
Standard Deviation 297.2
|
|
Biomarkers (IL-6, TNF-a)
IL-6 (Pre 2nd Dose)
|
311.3 pg/ml
Standard Deviation 660.4
|
310.4 pg/ml
Standard Deviation 528.2
|
|
Biomarkers (IL-6, TNF-a)
IL-6 (Post 2nd Dose)
|
91.0 pg/ml
Standard Deviation 245.6
|
316.8 pg/ml
Standard Deviation 373.7
|
|
Biomarkers (IL-6, TNF-a)
TNF-a (Pre 1st Dose)
|
43.64 pg/ml
Standard Deviation 72.9
|
11.26 pg/ml
Standard Deviation 13.6
|
|
Biomarkers (IL-6, TNF-a)
TNF-a (Post 1st Dose)
|
8.87 pg/ml
Standard Deviation 12.3
|
39.19 pg/ml
Standard Deviation 104.5
|
|
Biomarkers (IL-6, TNF-a)
IL-6 (Pre 1st Dose)
|
159.09 pg/ml
Standard Deviation 293.0
|
162.16 pg/ml
Standard Deviation 185.9
|
|
Biomarkers (IL-6, TNF-a)
TNF-a (Pre 2nd Dose
|
68.0 pg/ml
Standard Deviation 109.5
|
107.8 pg/ml
Standard Deviation 175.3
|
|
Biomarkers (IL-6, TNF-a)
TNF-a (Post 2nd Dose)
|
50.1 pg/ml
Standard Deviation 140.2
|
185.0 pg/ml
Standard Deviation 275.8
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21 & Day 30Population: Only "observed values" were used.
Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
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
|
114.05 Ratio
Standard Deviation 30.93
|
|
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
|
184.53 Ratio
Standard Deviation 95.51
|
|
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
|
338.40 Ratio
Standard Deviation 42.57
|
|
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
|
398.33 Ratio
Standard Deviation 24.01
|
|
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
|
—
|
SECONDARY outcome
Timeframe: up to Day 30Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment
Outcome measures
| Measure |
Arm A - Itolizumab + BSC
n=20 Participants
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 Participants
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Number and Percentage of Patients With Radiological Response
|
9 Participants
|
1 Participants
|
Adverse Events
Arm A - Itolizumab + BSC
Serious events: 3 serious events
Other events: 18 other events
Deaths: 1 deaths
Arm B - Best Supportive Care (BSC)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A - Itolizumab + BSC
n=22 participants at risk
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 participants at risk
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion due to underlying hypothyroidism
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Injury, poisoning and procedural complications
Anaphylactic reaction
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/22 • 30 days
|
20.0%
2/10 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/22 • 30 days
|
20.0%
2/10 • Number of events 2 • 30 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/22 • 30 days
|
20.0%
2/10 • Number of events 2 • 30 days
|
Other adverse events
| Measure |
Arm A - Itolizumab + BSC
n=22 participants at risk
Itolizumab 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
|
Arm B - Best Supportive Care (BSC)
n=10 participants at risk
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
|
|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
General disorders
Chills
|
22.7%
5/22 • Number of events 6 • 30 days
|
0.00%
0/10 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Investigations
Fibrin D dimer increased
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Investigations
Low density lipoprotein increased
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Investigations
Lymphocyte count decreased
|
50.0%
11/22 • Number of events 11 • 30 days
|
20.0%
2/10 • Number of events 2 • 30 days
|
|
Investigations
Non-high-density lipoprotein cholesterol increased
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Investigations
Platelet count decreased
|
4.5%
1/22 • Number of events 1 • 30 days
|
0.00%
0/10 • 30 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
4/22 • Number of events 4 • 30 days
|
10.0%
1/10 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.1%
2/22 • Number of events 2 • 30 days
|
10.0%
1/10 • Number of events 1 • 30 days
|
|
Infections and infestations
Fungal infection
|
0.00%
0/22 • 30 days
|
10.0%
1/10 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place