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COVID-19 ICU Patients for Bacterial Infection (BVAC19 Trial)

N/A
Waitlist Available
Led By Jan Bakker, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day of icu discharge (up to day 21)
Awards & highlights

Summary

In patients with SARS-CoV-2 or bacterial infection admitted to the intensive care unit (ICU), the state of the intravascular volume, the characteristics of the blood volume components, and the development of a vascular leak is currently unknown. The relationship of these parameters with parameters of cardiac performance, lung edema and sublingual microcirculatory perfusion parameters have never been studied.

Eligible Conditions
  • Bacterial Infection
  • Sepsis
  • Coronavirus
  • Acute Respiratory Distress Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day of icu discharge (up to day 21)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day of icu discharge (up to day 21) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Absolute Plasma Volume
Change in Absolute Red Blood Cell Volume
Change in Absolute Total Blood Volume
+19 more
Secondary outcome measures
Number of Participants Requiring Renal Replacement Therapy
Number of Participants with New Onset Renal Injury

Trial Design

2Treatment groups
Experimental Treatment
Group I: ICU Patients with bacterial infectionExperimental Treatment3 Interventions
Patients who are admitted to the ICU with a confirmed bacterial infection. Bacterial infection is defined as the clinical suspicion of a bacterial infection with the presence of two or more clinical markers of infection: abnormal body temperature (>38C or <36C) increased heart rate (>90 b/min), increased respiratory rate > 20/min or a decreased arterial CO2: PaCO2 < 32 mmHg Abnormal white blood cell count: < 4000 mm3 or > 12,000 /mm3 or > 10% immature cells OR The presence of a positive (blood) culture with bacterial growth.
Group II: COVID-19 ICU PatientsExperimental Treatment3 Interventions
Patients who are admitted to the ICU with a confirmed SARS-CoV-2 infection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sublingual Microcirculation
2020
N/A
~40
BVA-100
2020
N/A
~90
Transpulmonary Thermodilution (TPTD)
2020
N/A
~40

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
848,079 Total Patients Enrolled
Daxor CorporationIndustry Sponsor
12 Previous Clinical Trials
290 Total Patients Enrolled
Jan Bakker, MD, PhDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
415 Total Patients Enrolled
~8 spots leftby Sep 2025
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