MedTrace Logo

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

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

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

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=99 Participants
48.30 Years
STANDARD_DEVIATION 14.62 • n=107 Participants
49.13 Years
STANDARD_DEVIATION 13.21 • n=206 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Sex: Female, Male
Male
19 Participants
n=99 Participants
7 Participants
n=107 Participants
26 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian
20 Participants
n=99 Participants
10 Participants
n=107 Participants
30 Participants
n=206 Participants
Region of Enrollment
India
20 participants
n=99 Participants
10 participants
n=107 Participants
30 participants
n=206 Participants

PRIMARY outcome

Timeframe: One-month

1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30

Outcome measures

Outcome measures
Measure
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
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
One-month Mortality Rate Between the Two Arms
3 participants
0 participants

PRIMARY outcome

Timeframe: Day 7, Day 14, Day 21 & Day 30

Population: 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

Outcome measures
Measure
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
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
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 7
5 participants
17 participants
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 14
7 participants
19 participants
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 21
7 participants
20 participants
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Day 30/EOS
7 participants
20 participants

PRIMARY outcome

Timeframe: Day 30

Number of patients needing Intubation/IMV post treatment

Outcome measures

Outcome measures
Measure
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
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
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
2 participants
0 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
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
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
Reduction in Proportion of Patients on Non-invasive Ventilation
Baseline (Day 1)
4 participants
5 participants
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 7
0 participants
0 participants
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 14
1 participants
5 participants
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 21
1 participants
5 participants
Reduction in Proportion of Patients on Non-invasive Ventilation
Day 30/EOS
1 participants
5 participants

PRIMARY outcome

Timeframe: Day 7, Day14, Day 21 & Day30

Population: 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

Outcome measures
Measure
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
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
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 7
6 participants
18 participants
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 14
7 participants
19 participants
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 21
7 participants
20 participants
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Day 30/EOS
7 participants
20 participants

PRIMARY outcome

Timeframe: Day7, Day14, Day21 & Day 30

Population: 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 30

Population: 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 30

Population: only "observed values" were used.

Mean Change from Baseline in Ferritin

Outcome measures

Outcome measures
Measure
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
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
Mean Change From Baseline in Ferritin
Day 7
-87.05 ng/mL
Standard Deviation 140.99
-117.8 ng/mL
Standard Deviation 1477.0
Mean Change From Baseline in Ferritin
Day 14
-209.6 ng/mL
Standard Deviation 177.33
-713.9 ng/mL
Standard Deviation 693.68
Mean Change From Baseline in Ferritin
Day 21
4238 ng/mL
Standard Deviation 8319.0
-780.9 ng/mL
Standard Deviation 630.61
Mean Change From Baseline in Ferritin
Day 30/EOS
-234.4 ng/mL
Standard Deviation 405.67
-479.3 ng/mL
Standard Deviation 620.95

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

Outcome measures
Measure
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
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
Mean Change From Baseline in LDH
Day 7
-44.29 U/L
Standard Deviation 176.85
-134 U/L
Standard Deviation 174.67
Mean Change From Baseline in LDH
Day 14
-195.2 U/L
Standard Deviation 119.93
-195.8 U/L
Standard Deviation 291.94
Mean Change From Baseline in LDH
Day 21
155.3 U/L
Standard Deviation 736.47
-308.1 U/L
Standard Deviation 202.76
Mean Change From Baseline in LDH
Day 30/EOS
-97 U/L
Standard Deviation 89.1
-212.7 U/L
Standard Deviation 188.48

PRIMARY outcome

Timeframe: Day 7, Day 14, Day 21 & Day 30

Population: Only "observed values" were used.

Mean Change from Baseline in CRP

Outcome measures

Outcome measures
Measure
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
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
Mean Change From Baseline in CRP (C-reactive Protein)
Day 7
-103.6 mg/L
Standard Deviation 87.48
-61.69 mg/L
Standard Deviation 81.86
Mean Change From Baseline in CRP (C-reactive Protein)
Day 14
-107.2 mg/L
Standard Deviation 104.66
-81.65 mg/L
Standard Deviation 74.71
Mean Change From Baseline in CRP (C-reactive Protein)
Day 21
-127.5 mg/L
Standard Deviation 124.04
-90.99 mg/L
Standard Deviation 81.97
Mean Change From Baseline in CRP (C-reactive Protein)
Day 30/EOS
-127.6 mg/L
Standard Deviation 59.68
-103.2 mg/L
Standard Deviation 100.53

PRIMARY outcome

Timeframe: Day 7, Day 14, Day 21 & Day 30

Population: Only "observed values" were used.

Outcome measures

Outcome measures
Measure
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
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
Mean Change From Baseline D-Dimer
Day 7
2.30 µg/ml
Standard Deviation 6.67
-1.43 µg/ml
Standard Deviation 6.31
Mean Change From Baseline D-Dimer
Day 30
-0.35 µg/ml
Standard Deviation 0.08
-2.63 µg/ml
Standard Deviation 2.43
Mean Change From Baseline D-Dimer
Day 14
-0.68 µg/ml
Standard Deviation 0.79
-0.45 µg/ml
Standard Deviation 6.39
Mean Change From Baseline D-Dimer
Day 21
8.54 µg/ml
Standard Deviation 14.40
-4.35 µg/ml
Standard Deviation 6.13

SECONDARY outcome

Timeframe: day 7, day 14 ,day 21 & day 30

Population: Only "observed values" were used.

Mean change From baseline in Lymphocyte count

Outcome measures

Outcome measures
Measure
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
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
Mean Change From Baseline of Absolute Lymphocyte Count
Day 7
45.88 cells/mm^3
Standard Deviation 762.37
119.95 cells/mm^3
Standard Deviation 478.63
Mean Change From Baseline of Absolute Lymphocyte Count
Day 14
142.60 cells/mm^3
Standard Deviation 731.94
421.25 cells/mm^3
Standard Deviation 569.71
Mean Change From Baseline of Absolute Lymphocyte Count
Day 21
10.00 cells/mm^3
Standard Deviation 930.16
701.55 cells/mm^3
Standard Deviation 625.34
Mean Change From Baseline of Absolute Lymphocyte Count
Day 30/EOS
85.00 cells/mm^3
Standard Deviation 601.04
719.75 cells/mm^3
Standard Deviation 1004.0

SECONDARY outcome

Timeframe: Pre and Post 1st dose; Pre and Post 2nd dose

Population: Only "observed values" were used.

Mean values of Pre and Post 1st and 2nd dose are shown

Outcome measures

Outcome measures
Measure
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
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
Biomarkers (IL-6, TNF-a)
TNF-a (Pre 2nd Dose
107.8 pg/ml
Standard Deviation 175.3
68.0 pg/ml
Standard Deviation 109.5
Biomarkers (IL-6, TNF-a)
TNF-a (Post 2nd Dose)
185.0 pg/ml
Standard Deviation 275.8
50.1 pg/ml
Standard Deviation 140.2
Biomarkers (IL-6, TNF-a)
IL-6 (Pre 1st Dose)
162.16 pg/ml
Standard Deviation 185.9
159.09 pg/ml
Standard Deviation 293.0
Biomarkers (IL-6, TNF-a)
IL-6 (Post 1st Dose)
211.52 pg/ml
Standard Deviation 297.2
42.98 pg/ml
Standard Deviation 52.9
Biomarkers (IL-6, TNF-a)
IL-6 (Pre 2nd Dose)
310.4 pg/ml
Standard Deviation 528.2
311.3 pg/ml
Standard Deviation 660.4
Biomarkers (IL-6, TNF-a)
IL-6 (Post 2nd Dose)
316.8 pg/ml
Standard Deviation 373.7
91.0 pg/ml
Standard Deviation 245.6
Biomarkers (IL-6, TNF-a)
TNF-a (Pre 1st Dose)
11.26 pg/ml
Standard Deviation 13.6
43.64 pg/ml
Standard Deviation 72.9
Biomarkers (IL-6, TNF-a)
TNF-a (Post 1st Dose)
39.19 pg/ml
Standard Deviation 104.5
8.87 pg/ml
Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 14, Day 21 & Day 30

Population: Only "observed values" were used.

Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)

Outcome measures

Outcome measures
Measure
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
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
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
126.57 Ratio
Standard Deviation 38.31
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
203.50 Ratio
Standard Deviation 95.51
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
283.43 Ratio
Standard Deviation 104.26
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
350.25 Ratio
Standard Deviation 70.36
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 30

Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment

Outcome measures

Outcome measures
Measure
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
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
Number and Percentage of Patients With Radiological Response
1 Participants
9 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

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

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

Dr. Subramanian Loganathan

Biocon Biologics India Limited

Phone: 0802808

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place