NCT07465302

Brief Summary

SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
26mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Sep 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 27, 2026

Last Update Submit

April 30, 2026

Conditions

Traumatic Spinal Cord Injuries

Keywords

normobaric hyperoxiahyperoxiabiomarkerstraumatic spinal cord injuryFiO2 100%

Outcome Measures

Primary Outcomes (3)

  • Feasibility of early normobaric hyperoxic therapy

    Proportion of subjects receiving first normobaric hyperoxia therapy.

    24 hours from injury

  • Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically

    Serial PaO2

    From enrollment to the end of intervention period at 5 days

  • Preliminary safety of intermittent normobaric hyperoxia

    Four-point end-organ toxicity surveillance.

    From completion of first treatment to end of 6 month follow up period

Secondary Outcomes (6)

  • Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration

    From enrollment to the end of intervention period at 5 days

  • Exploratory safety objectives

    From enrollment to end of 6 month follow up period

  • Feasibility - Timely Placement of Lumbar Drain

    Time of injury to 24hr post injury.

  • Feasibility - Completion of Required Monitoring Lines

    Day 0 to day 5

  • Protocol Adherence - Sampling Deviations

    Enrollment to end of 6 month follow up period

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Normobaric hyperoxia

Other: Normobaric Hyperoxia

Interventions

Normobaric HyperoxiaOTHER

Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.

Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated ICF by the subject or LAR
  • Stated willingness to comply with all study procedures for the duration of the study
  • Male or female subjects, aged ≥18 and ≤ 85 years
  • Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)
  • Awake and able to interact and follow commands
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C
  • Need for mechanical ventilation (MV), as determined by the treating physician
  • Baseline PaO2 \>80 mmHg before enrollment
  • Capacity to initiate the study intervention within 24 hours of injury

You may not qualify if:

  • Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V
  • AIS grades D or E at time of arrival to hospital
  • Persistent hypoxia requiring \>40% FiO2 to maintain PaO2 \>80 mmHg
  • Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia \<100,000/μL or International Normalized Ratio \>1.5)
  • Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
  • Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
  • Participation in a concurrent investigational/interventional study (observational studies allowed)
  • Known to be pregnant, or with a positive pregnancy test
  • Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
  • Patient has any other clinically significant medical condition as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carolina Maciel, MD, MSCR

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Katharina Busl, MD, MS

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Daryl Fields, MD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kline

CONTACT

352-273-9000andrew.kline@neurosurgery.ufl.edu

Ralisa Pop

CONTACT

(352) 294-5693Ralisa.Pop@neurology.ufl.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 11, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

May 1, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) underlying the primary results of this study-including de-identified clinical, physiologic, and outcome variables-will be made available following publication of the main results. Data will be shared in accordance with institutional policies and applicable regulations after all direct identifiers have been removed using a standardized de-identification protocol. The curated dataset, accompanying data dictionary, and analytic code (when applicable) will be deposited in the National Spinal Cord Injury Statistical Center (https://sites.uab.edu/nscisc/), where they will be accessible under a controlled-access model. Qualified researchers may request access by submitting a brief proposal outlining the intended use of the data; requests will be reviewed by the study team to ensure scientific validity and compliance with participant privacy protections. Data will remain available for the duration required by institutional policy.

Locations

US(1)