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Evaluation of FDY-5301 in Major Trauma Patients in ICU

Primary Purpose

ICU Acquired Weakness

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FDY-5301
Placebo
Sponsored by
Faraday Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ICU Acquired Weakness focused on measuring ICU acquired weakness, PICS, SIRS, Muscle wasting and weakness, muscle function, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years

  2. Major trauma defined as:

    1. thoracic and/or abdominal and/or pelvic injury
    2. necessitating admission to ICU with ventilation anticipated for at least 24 hrs
    3. hemorrhagic shock defined as systolic blood pressure (SBP) <90 mmHG requiring blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or within one hour after hospital arrival
  3. IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury)

Exclusion Criteria:

  1. Likely to die within 48 hrs from time of screening

  2. Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example:

    a. Computed tomography imaging showing evidence of traumatic brain injury (TBI), combined with best representative Glasgow Coma Score (GCS) Motor Score of ≤4 at approximately 24 hrs post injury

  3. Evidence of nonreversible spinal cord injury
  4. Bilateral femoral fractures
  5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
  6. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
  7. Known allergy to iodine
  8. Chronic renal disease requiring dialysis
  9. Body mass index (BMI) >40 kg/m2 or <16 kg/m2
  10. Body weight (BW) >140 kg (or >309 lb)
  11. History or presence of debilitating neurologic or other neuromuscular disease (e.g., spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of randomization
  12. Current metastatic cancer
  13. Solid organ transplant recipient
  14. Evidence of pre-existing sarcopenia defined as having a pre-trauma Clinical Frailty Score (CFS) of ≥5 or based on clinical judgement (e.g. frail by appearance, cachexia, etc.)
  15. Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6 months of randomization (inhaled and topical steroids are allowed)
  16. Use of investigational drugs or devices within 30 days of randomization
  17. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301

Sites / Locations

  • Harbor-UCLA Medical Center
  • University of Florida Health Shands Hospital
  • Massachusetts General Hospital, Harvard Medical School
  • The Ohio State University Wexner Medical Center
  • Harborview

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

FDY-5301 Low Dose (1 mg/kg)

FDY-5301 High Dose (2 mg/kg)

Placebo

Arm Description

FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.

FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.

Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Other Names: Saline

Outcomes

Primary Outcome Measures

Chelsea Critical Care Physical Assessment Tool
Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.
Organ Dysfunction Total Time to Recovery
Organ dysfunction total time to recovery (TTR) until Day 28

Secondary Outcome Measures

Medical Research Council Sum Score
Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.
Sequential Organ Failure Assessment Score
The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.
Overall Survival at Day 28
Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.

Full Information

First Posted
April 20, 2020
Last Updated
June 12, 2023
Sponsor
Faraday Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04430283
Brief Title
Evaluation of FDY-5301 in Major Trauma Patients in ICU
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faraday Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
Detailed Description
The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to placebo in trauma ICU patients at risk of ICUAW. Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may help prevent or treat muscle weakness and organ dysfunction in major trauma patients. Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation in each group, the randomization will be stratified by the presence or absence of any pelvic or lower limb fractures. All subjects who satisfy the eligibility criteria will be randomly allocated to one of three treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo). All subjects will be followed for 6 months. This study will be conducted globally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Acquired Weakness
Keywords
ICU acquired weakness, PICS, SIRS, Muscle wasting and weakness, muscle function, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDY-5301 Low Dose (1 mg/kg)
Arm Type
Experimental
Arm Description
FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
Arm Title
FDY-5301 High Dose (2 mg/kg)
Arm Type
Experimental
Arm Description
FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Other Names: Saline
Intervention Type
Drug
Intervention Name(s)
FDY-5301
Intervention Description
FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.
Primary Outcome Measure Information:
Title
Chelsea Critical Care Physical Assessment Tool
Description
Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.
Time Frame
Day 10 or hospital discharge, whichever occurs first.
Title
Organ Dysfunction Total Time to Recovery
Description
Organ dysfunction total time to recovery (TTR) until Day 28
Time Frame
Day 28 or hospital discharge, whichever occurs first.
Secondary Outcome Measure Information:
Title
Medical Research Council Sum Score
Description
Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.
Time Frame
Day 28, or hospital discharge, whichever occurs first
Title
Sequential Organ Failure Assessment Score
Description
The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.
Time Frame
ICU hospital stay until Day 28 or ICU discharge if earlier
Title
Overall Survival at Day 28
Description
Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years Major trauma defined as: thoracic and/or abdominal and/or pelvic injury necessitating admission to ICU with ventilation anticipated for at least 24 hrs hemorrhagic shock defined as systolic blood pressure (SBP) <90 mmHG requiring blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or within one hour after hospital arrival IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury) Exclusion Criteria: Likely to die within 48 hrs from time of screening Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example: a. Computed tomography imaging showing evidence of traumatic brain injury (TBI), combined with best representative Glasgow Coma Score (GCS) Motor Score of ≤4 at approximately 24 hrs post injury Evidence of nonreversible spinal cord injury Bilateral femoral fractures Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization Known allergy to iodine Chronic renal disease requiring dialysis Body mass index (BMI) >40 kg/m2 or <16 kg/m2 Body weight (BW) >140 kg (or >309 lb) History or presence of debilitating neurologic or other neuromuscular disease (e.g., spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of randomization Current metastatic cancer Solid organ transplant recipient Evidence of pre-existing sarcopenia defined as having a pre-trauma Clinical Frailty Score (CFS) of ≥5 or based on clinical judgement (e.g. frail by appearance, cachexia, etc.) Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6 months of randomization (inhaled and topical steroids are allowed) Use of investigational drugs or devices within 30 days of randomization Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
University of Florida Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Massachusetts General Hospital, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Harborview
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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Evaluation of FDY-5301 in Major Trauma Patients in ICU

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