Evaluation of FDY-5301 in Major Trauma Patients in ICU
Condition: ICU Acquired Weakness
MeSH terms: Asthenia
Intervention: FDY-5301; Placebo
Intervention description: FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.; Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.
Masking: Double (Participant, Investigator)
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.
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ICU acquired weakness, PICS, SIRS; Muscle wasting and weakness; muscle function; quality of life

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)
    

Eligibility criteria:

        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