Clinical trial NCT04475588: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Cytokine Release Syndrome
Covid19
Lead sponsor: Biocon Limited
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: One-month Mortality Rate Between the Two Arms
timeFrame: One-month
measure: Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
timeFrame: Day 7, Day 14, Day 21 & Day 30
measure: Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
timeFrame: Day 30
measure: Reduction in Proportion of Patients on Non-invasive Ventilation
timeFrame: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
measure: Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
timeFrame: Day 7, Day14, Day 21 & Day30
measure: Reduction in Proportion of Patients- Invasive Mechanical Ventilation
timeFrame: Day7, Day14, Day21 & Day 30
measure: Reduction in Proportion of Patients-High Flow Nasal Oxygen
timeFrame: Day7 ,Day 14 ,Day 21, Day 30
measure: Mean Change From Baseline in Ferritin
timeFrame: Day 7, Day 14, Day 21 & Day 30
measure: Mean Change From Baseline in LDH
timeFrame: Day 7, Day14, Day 21 and Day 30.
measure: Mean Change From Baseline in CRP (C-reactive Protein)
timeFrame: Day 7, Day 14, Day 21 & Day 30
measure: Mean Change From Baseline D-Dimer
timeFrame: Day 7, Day 14, Day 21 & Day 30
Secondary outcomes:
measure: Mean Change From Baseline of Absolute Lymphocyte Count
timeFrame: day 7, day 14 ,day 21 & day 30
measure: Biomarkers (IL-6, TNF-a)
timeFrame: Pre and Post 1st dose; Pre and Post 2nd dose
measure: Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)
timeFrame: Baseline, Day 7, Day 14, Day 21 & Day 30
measure: Number and Percentage of Patients With Radiological Response
timeFrame: up to Day 30
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
city: Mumbai
country: India
facility: Seth GS Medical College and KEM Hospital
city: New Delhi
country: India
facility: MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences
Study officials:
References: