Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

NCT05013034 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: FWCSWG-COVID19-01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.

Conditions

SARS-CoV-2 Acute Respiratory Disease; SARS-CoV2 Infection; Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint

  1\. Proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization

  From time of randomization to Day 28

Secondary Outcomes (6)

• Avoidance of escalation of O2 therapy

  From time of randomization to Day 28

• Overall Survival

  From time of randomization to Day 28

• ICU Free Survival

  From time of randomization to Day 28

• ECMO Free Survival

  From time of randomization to Day 28

• Overall Survival at 90 days

  From time of randomization to Day 90

Other Outcomes (7)

• ICU length of stay

  From time of randomization to Day 90

• Hospital length of stay

  From time of randomization to Day 90

• ICU length of stay + death composite endpoint

  From time of randomization to Day 90

Study Arms (2)

Placebo (Current Standard of Care)

PLACEBO COMPARATOR

Current Standard of Care for SARS-CoV2 hypoxemic pulmonary diease

Drug: Placebo

Basiliximab

EXPERIMENTAL

Basiliximab in addition to Current Standard of Care for SARS-CoV2 hypoxemic pulmonary diease

Drug: Basiliximab Injection

Interventions

Basiliximab Injection DRUG

Subjects will be given IV dosing with basiliximab up to a maximum of 2 treatments (day 0 and day 4) for all patients on study. Treatment for patients may stop for unacceptable side-effects, the Investigator's, or patient's decision to discontinue treatment or other reasons. Exclusion for second dose is first dose returned patient to SpO2 ≥94% on room air.

Also known as: Simulect

Basiliximab

Placebo DRUG

Subjects will be given IV dosing with placebo (1/2 normal saline) up to a maximum of 2 treatments (day 0 and day 4) for all patients on study. Treatment for patients may stop for unacceptable side-effects, the Investigator's, or patient's decision to discontinue treatment or other reasons. Exclusion for second dose is first dose returned patient to SpO2 ≥94% on room air.

Placebo (Current Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient or legally authorized representative (LAR) willing and able to provide written or electronic or otherwise FDA-acceptable informed consent based on current FDA regulations.
• Hospitalized male or non-pregnant female
• RT-PCR confirmed SARS-CoV-2 using WHO consensus or validated primers
• Meet the Following Criteria:
• Deficiency in Oxygenation as defined by the Berlin ARDS Criteria (27):
• Timing: Within 1 week of onset of symptoms Imaging: Bilateral pulmonary infiltrates
• Oxygenation (any):
• Mild: 200 mmHg \< PaO2/FiO2 ≤ 300 mmHg Moderate: 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg Severe: PaO2/FiO2 ≤ 100 mmHg and
• Requiring oxygen support in the form of High Flow Nasal Cannula (HFNC), non-invasive positive pressure ventilation, intubation and mechanical ventilation, or initiation of ECMO and
• Any one or more of the following:
• Elevated CRP (\>10 gm/dL)
• Elevated Ferritin (\>1000)
• Neutrophil/lymphocyte ratio \>3.3
• Patient will receive current clinical standard of care. This includes inpatient use of remdesivir, dexamethasone, convalescent plasma, or pre-hospitalization outpatient treatment with casirivimab and imdevima
• Age ≥ 18 years

You may not qualify if:

• Off label use of other drugs
• WOCBP unwilling to use acceptable birth control for 5 weeks, or male partner of a WOCBP unwilling to use male barrier method (condom) plus effective second method birth control for partner
• Pregnant women
• Pancytopenia
• Hgb\< 8 g/dL (male) or \< 7 g/dL (female)
• WBC\<2.0 x 109/L
• PLT\< 50 x 109/L
• \) Enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) Any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.
• \) Known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the SARS-CoV-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab.
• \) Any patient with multi-organ system failure or on intravenous vasopressor support 8) Do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

Sponsors & Collaborators

• Fort Worth Clinical Sciences Working Group: lead
• TCU and UNTHSC School of Medicine: collaborator

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• mohanakrishnan sathyamoorthy

  FWCSWG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohanakrishnan sathyamoorthy, md

CONTACT

817423-8585; m.sathyamoorthy@tcu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Model Details: Number of Subjects A total of 300 subjects will be enrolled: 150 will be randomized to the basiliximab arm and 150 to the placebo arm in a 1:1 distribution. Treatment Assignments Qualified individuals will be randomized with a superiority design to either basiliximab (Simulect) or placebo. Study drug or placebo will be double blinded and administered on day 0 for all subjects. A second dose may be administered on Day 4 if first dose did not return the subject to a SpO2 ≥94% on room air. Criteria for Study Termination Although the FWCSWG intends to complete the study, the FWCSWG reserves the right to discontinue the study at any time for clinical or administrative reasons, or if required by regulatory agencies. If the FWCSWG discontinues the study, all study drugs will be discontinued and the investigator will be responsible for securing any alternative therapy to be administered, as appropriate.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 19, 2021
• Study Start: October 15, 2021
• Primary Completion: October 15, 2022
• Study Completion: December 1, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08