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OpenTrials
Completed

NCT Number: NCT04475588

Efficacy and Safety of Itolizumab in COVID-19 Complications

Randomized, Parallel Group, Active Controlled Trial

Completed

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Key information

Conditions

Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Cytokine Release Syndrome Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Shock Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seth GS Medical College and KEM Hospital, Mumbai, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itolizumab IV infusion

Drug

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

Best Supportive Care (BSC)

Drug

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

Primary outcomes

  1. 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

  2. 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%

  3. Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)

    Time frame: Day 30

    Number of patients needing Intubation/IMV post treatment

  4. 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

  5. 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).

  6. Reduction in Proportion of Patients- Invasive Mechanical Ventilation

    Time frame: Day7, Day14, Day21 & Day 30

    Patient improved from invasive ventilation over time from baseline.

  7. 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.

  8. Mean Change From Baseline in Ferritin

    Time frame: Day 7, Day 14, Day 21 & Day 30

    Mean Change from Baseline in Ferritin

  9. Mean Change From Baseline in LDH

    Time frame: Day 7, Day14, Day 21 and Day 30.

    Mean Change from Baseline in LDH

  10. 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

  11. Mean Change From Baseline D-Dimer

    Time frame: Day 7, Day 14, Day 21 & Day 30

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Biocon Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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