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

NCT05013034 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-08-19

No results posted yet for this study

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

Interventions

DRUG

Basiliximab Injection

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • TCU and UNTHSC School of Medicine

    collaborator OTHER

  • Fort Worth Clinical Sciences Working Group

    lead OTHER

Principal Investigators

  • mohanakrishnan sathyamoorthy · FWCSWG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-10-15
Completion
2022-12-01
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013034 on ClinicalTrials.gov