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Efficacy and Safety of Itolizumab in COVID-19 Complications

Primary Purpose

Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Itolizumab IV infusion

Best supportive care (BSC)

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Seth GS Medical College and KEM Hospital
MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
All India Institute Of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A - Itolizumab + BSC

Arm B - Best supportive care (BSC)

Arm Description

Outcomes

Primary Outcome Measures

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

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%

Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)

Number of patients needing Intubation/IMV post treatment

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

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).

Reduction in Proportion of Patients- Invasive Mechanical Ventilation

Patient improved from invasive ventilation over time from baseline.

Reduction in Proportion of Patients-High Flow Nasal Oxygen

Patient improved from High Flow Nasal Oxygen over time from baseline.

Mean Change From Baseline in Ferritin

Mean Change from Baseline in Ferritin

Mean Change From Baseline in LDH

Mean Change from Baseline in LDH

Mean Change From Baseline in CRP (C-reactive Protein)

Mean Change from Baseline in CRP

Mean Change From Baseline D-Dimer

Secondary Outcome Measures

Mean Change From Baseline of Absolute Lymphocyte Count

Mean change From baseline in Lymphocyte count

Biomarkers (IL-6, TNF-a)

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)

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

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

Full Information

NCT ID

NCT04475588

First Posted

July 16, 2020

Last Updated

June 10, 2021

Sponsor

Biocon Limited

1. Study Identification

Unique Protocol Identification Number

NCT04475588

Brief Title

Efficacy and Safety of Itolizumab in COVID-19 Complications

Official Title

A Multi-Centre, Open Label, Two Arm Randomized, Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

July 7, 2020 (Actual)

Study Completion Date

July 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocon Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A - Itolizumab + BSC

Arm Type

Experimental

Arm Title

Arm B - Best supportive care (BSC)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Itolizumab IV infusion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Best supportive care (BSC)

Intervention Description

Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc

Primary Outcome Measure Information:

Title

One-month Mortality Rate Between the Two Arms

Description

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

Time Frame

One-month

Title

Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2

Description

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

Title

Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)

Description

Number of patients needing Intubation/IMV post treatment

Time Frame

Day 30

Title

Reduction in Proportion of Patients on Non-invasive Ventilation

Description

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

Title

Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2

Description

Time Frame

Day 7, Day14, Day 21 & Day30

Title

Reduction in Proportion of Patients- Invasive Mechanical Ventilation

Description

Patient improved from invasive ventilation over time from baseline.

Time Frame

Day7, Day14, Day21 & Day 30

Title

Reduction in Proportion of Patients-High Flow Nasal Oxygen

Description

Patient improved from High Flow Nasal Oxygen over time from baseline.

Time Frame

Day7 ,Day 14 ,Day 21, Day 30

Title

Mean Change From Baseline in Ferritin

Description

Mean Change from Baseline in Ferritin

Time Frame

Day 7, Day 14, Day 21 & Day 30

Title

Mean Change From Baseline in LDH

Description

Mean Change from Baseline in LDH

Time Frame

Day 7, Day14, Day 21 and Day 30.

Title

Mean Change From Baseline in CRP (C-reactive Protein)

Description

Mean Change from Baseline in CRP

Time Frame

Day 7, Day 14, Day 21 & Day 30

Title

Mean Change From Baseline D-Dimer

Time Frame

Day 7, Day 14, Day 21 & Day 30

Secondary Outcome Measure Information:

Title

Mean Change From Baseline of Absolute Lymphocyte Count

Description

Mean change From baseline in Lymphocyte count

Time Frame

day 7, day 14 ,day 21 & day 30

Title

Biomarkers (IL-6, TNF-a)

Description

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

Time Frame

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

Title

Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)

Description

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

Title

Number and Percentage of Patients With Radiological Response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,

City

Mumbai

ZIP/Postal Code

400008

Country

India

Facility Name

Seth GS Medical College and KEM Hospital

City

Mumbai

ZIP/Postal Code

400012

Country

India

Facility Name

MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital

City

New Delhi

ZIP/Postal Code

110002

Country

India

Facility Name

All India Institute Of Medical Sciences

City

New Delhi

ZIP/Postal Code

110029

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Safety of Itolizumab in COVID-19 Complications

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