Efficacy and Safety of Itolizumab in COVID-19 Complications

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-07-07

Brief Summary

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Randomized, Parallel Group, Active Controlled Trial

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Detailed Description

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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.

Conditions

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Acute Respiratory Distress Syndrome Cytokine Release Syndrome Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A - Itolizumab + BSC

Group Type EXPERIMENTAL

Itolizumab IV infusion

Intervention Type 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)

Intervention Type DRUG

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

Arm B - Best supportive care (BSC)

Group Type ACTIVE_COMPARATOR

Best supportive care (BSC)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Best supportive care (BSC)

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No