Efficacy and Safety of Itolizumab in COVID-19 Complications

June 10, 2021 updated by: Biocon Limited

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

Randomized, Parallel Group, Active Controlled Trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India, 400012
        • Seth GS medical college and KEM Hospital
      • Mumbai, India, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110002
        • MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Arm A - Itolizumab + BSC
Drug: 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)
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
ACTIVE_COMPARATOR: Arm B - Best supportive care (BSC)
Drug: Best supportive care (BSC)
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
One-month Mortality Rate Between the Two Arms
Time Frame: One-month
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
One-month
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Time Frame: 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%
Day 7, Day 14, Day 21 & Day 30
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
Time Frame: Day 30
Number of patients needing Intubation/IMV post treatment
Day 30
Reduction in Proportion of Patients on Non-invasive Ventilation
Time Frame: 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
Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Time Frame: 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).
Day 7, Day14, Day 21 & Day30
Reduction in Proportion of Patients- Invasive Mechanical Ventilation
Time Frame: Day7, Day14, Day21 & Day 30
Patient improved from invasive ventilation over time from baseline.
Day7, Day14, Day21 & Day 30
Reduction in Proportion of Patients-High Flow Nasal Oxygen
Time Frame: Day7 ,Day 14 ,Day 21, Day 30
Patient improved from High Flow Nasal Oxygen over time from baseline.
Day7 ,Day 14 ,Day 21, Day 30
Mean Change From Baseline in Ferritin
Time Frame: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in Ferritin
Day 7, Day 14, Day 21 & Day 30
Mean Change From Baseline in LDH
Time Frame: Day 7, Day14, Day 21 and Day 30.
Mean Change from Baseline in LDH
Day 7, Day14, Day 21 and Day 30.
Mean Change From Baseline in CRP (C-reactive Protein)
Time Frame: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in CRP
Day 7, Day 14, Day 21 & Day 30
Mean Change From Baseline D-Dimer
Time Frame: Day 7, Day 14, Day 21 & Day 30
Day 7, Day 14, Day 21 & Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline of Absolute Lymphocyte Count
Time Frame: day 7, day 14 ,day 21 & day 30
Mean change From baseline in Lymphocyte count
day 7, day 14 ,day 21 & day 30
Biomarkers (IL-6, TNF-a)
Time Frame: Pre and Post 1st dose; Pre and Post 2nd dose
Mean values of Pre and Post 1st and 2nd dose are shown
Pre and Post 1st dose; Pre and Post 2nd dose
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
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
Number and Percentage of Patients With Radiological Response
Time Frame: 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
up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocon Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITOLI-C19-02-I-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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