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Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin

UCI Specialty Area: Pulmonology
Principal Investigator: Alpesh Amin
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Of Care For Moderate-To-Severe Ards Due To Pneumonia Or Other Infections
A Study On:
Acute Respiratory Distress Syndrome (ARDS)
Lung - Pulmonary

Study Description

Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS. The Sponsor aims to identify as early as possible patients in the hospital who have developed acute hypoxemic respiratory failure within 7 days of the precipitating infection (often fever, rigors, chills, increased heart rate, increased respiratory rate, pain, cough, etc.) leading to ARDS resulting in mechanical or noninvasive ventilation or high-flow nasal oxygen (HFNO) supplementation with greater than or equal to 50% O2 at a flow rate of greater than or equal to 30 L/min. Patients who do not qualify for the study at the initial screening visit because of mild ARDS may subsequently progress to moderate-to-severe ARDS and should be reassessed at least daily for the 7 days following the precipitating infection.

Once informed consent is obtained, the following assessments/procedures will be performed:

  1. Confirm the potential participant has acute hypoxemic respiratory failure qualifying as moderate-to-severe ARDS for less than or equal to 48 hours following a suspected or confirmed infection within the preceding week. Moderate-to-severe ARDS is defined by the calculated or estimated ratio of arterial pressure of O2 to the fraction of inspired O2 [P/F ratio] less than or equal to 150. The P/F ratio will be computed from the most recent arterial blood gas obtained no more than 12 hours earlier than randomization. For potential subjects on high-flow nasal oxygen with greater than or equal to 50% O2 at a flow rate of greater than or equal to 30 L/min, the P/F ratio will be estimated assuming 50% delivered O2. If eligible and entered in the trial, the following steps should be taken.
  2. Record medical history, including concomitant medications and current clinical status. Specify the site and etiology (if known) of infection, indicating if the lung ("direct ARDS") or another organ ("indirect ARDS") is the primary site of infection.
  3. Perform pregnancy test (urine or blood) for women of childbearing potential if not already performed during the current hospitalization.
  4. Collect pretreatment blood samples for measurement of baseline pGSN and analysis of antibodies against pGSN.
  5. Perform physical examination and document results of the chest x-ray (CXR) and/or computed tomography (CT) scan, if CXR is inadequate if not already available as per SOC.
  6. Obtain blood and sputum cultures and electrocardiogram (EKG) per SOC (if not already performed). Document the site of infection by collecting specimens as indicated: sputum (bacterial, viral, and mycobacterial, as indicated) and blood cultures, sputum Gram-stains, antigen detection on respiratory and urine specimens, and syndromic nucleic acid amplification tests (NAATs) on respiratory specimens (including a viral and other respiratory pathogen polymerase chain reaction [PCR] panel), where possible. Other specimens from possible sites of infection (e.g., urine, intra-abdominal drainage, skin or soft-tissue abscesses) should be cultured when available.
  7. Measure routine lab tests at local (hospital) laboratory per local custom/SOC collect aliquots f- blood for subsequent biomarker assays (including, but not limited to C-reactive protein [CRP], procalcitonin, interleukin [IL]1B, IL6, IL10, and tumor necrosis factor [TNF]) for analysis at the central laboratory.
  8. If eligibility criteria are satisfied, the subject will be randomized 1:1 (rhu-pGSN:placebo) by site to a treatment group and treated within 12 hours of randomization and no later than 48 hours after the diagnosis of moderate-to-severe ARDS.

Eligibility

  1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist

a. Investigator or designee to note radiologic findings in the electronic case report form (eCRF)

b. Radiology report and conclusion should be summarized in the eCRF

c. A digital copy of the radiograph uploaded and saved for review

  1. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for less than or equal to 48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 less than or equal to150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP greater than or equal to 5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.
  2. Age greater than or equal to 18 years
  3. Informed consent obtained from subject/next of kin/legal proxy
  4. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team
  5. During the course of the study starting at screening and for at least 3 months after their final study treatment:

a. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods

b. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner

c. All subjects must agree not to donate sperm or eggs

  1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.
  2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
  3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
  4. Pregnant or lactating women
  5. Previous splenectomy
  6. Any vaccination in the previous 30 days
  7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
  8. Known allergy to study drug or excipients
  9. Weight greater than or equal to 125 kg
  10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months
  11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease
  12. Chronic mechanical ventilation or dialysis
  13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy less than 6 months unrelated to acute infection in the opinion of the Investigator.
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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