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Efficacy and Safety of Itolizumab in COVID-19 Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475588
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Biocon Limited

Study Description
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Brief Summary:
Randomized, Parallel Group, Active Controlled Trial

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Cytokine Release Syndrome Covid19 Drug: Itolizumab IV infusion Drug: Best supportive care" which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy Phase 2

Detailed Description:

This is a Multi-Centric, Open label, Two Arm Randomized, Pivotal 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 daily recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature (highest temperature of the day), 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open Label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : July 8, 2020
Actual Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Best supportive care with Itolizumab Drug: Itolizumab IV infusion
Start at 1.6 mg/kg dose iv infusion, if well tolerated and improvement in patient observed, investigator has the discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen.

Drug: Best supportive care" which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy
The best supportive care will be as per institution standard
Active Comparator: Best supportive care Drug: Best supportive care" which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy
The best supportive care will be as per institution standard


Outcome Measures
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Primary Outcome Measures :
  1. One-month mortality rate between the two arms [ Time Frame: One-month ]
    1-month mortality is defined as the ratio of patients who will live after 1 month from study start out of those registered at baseline


Secondary Outcome Measures :
  1. Biomarkers (IL-6, TNF-a, IL1, IL17, etc…) [ Time Frame: One Month ]
    Baseline, during treatment, One month

  2. Lymphocyte count [ Time Frame: One Month ]
    Baseline, during treatment (Before every dose and 12 h post dose) up to 1 month

  3. CRP (C-reactive protein) level [ Time Frame: One Month ]
    Baseline, during treatment (Before every dose and 12 h post dose) up to 1 month

  4. PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: One Month ]
    Baseline, during treatment (Before every dose and 12 h post dose) up to 1 month

  5. Radiological response [ Time Frame: one month ]
    At baseline, after seven days and if clinically indicated (up to 1 month)

  6. Duration of hospitalization [ Time Frame: One Month ]
    from baseline up to patients discharge (up to 1 month)

  7. Remission of respiratory symptoms [ Time Frame: One Month ]
    up to 1 month


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or more than 25% detoriation from the immediate previous value.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475588


Locations
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India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Mumbai, India, 400008
Seth GS Medical College and KEM Hospital
Mumbai, India, 400012
MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
New Delhi, India, 110002
All India Institute Of Medical Sciences
New Delhi, India, 110029
Sponsors and Collaborators
Biocon Limited
More Information
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Responsible Party: Biocon Limited
ClinicalTrials.gov Identifier: NCT04475588    
Other Study ID Numbers: ITOLI-C19-02-I-00
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
 Lung Injury
Anti-Bacterial Agents
Hydroxychloroquine
Antiviral Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents