Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19

Phase 2

Terminated

• Conditions: SARS (Severe Acute Respiratory Syndrome); Cytokine Storm; ARDS, Human; COVID-19; Sars-CoV2; Acute Respiratory Failure
• Interventions: Drug: Hyperbaric oxygen

• Registration Number: NCT04327505
• Lead Sponsor: Karolinska Institutet

Brief Summary

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure.

We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality.

The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

Detailed Description

Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19

Secondary objectives:

Main secondary objectives:

To evaluate if HBO:

* reduces mortality in severe cases of COVID-19.

* reduces morbidity associated with COVID-19.

* reduce the load on ICU resources in COVID-19.

* mitigate the inflammatory reaction in COVID-19.

Other secondary objectives (in selection):

To evaluate if HBO is safe for SARS-CoV-2 positive patients and staff.

Study design: Randomized, controlled, phase II, open label, multicentre

Study population: Adult patients with SARS-CoV-2 infection, with at least two risk factor for increased mortality, likely to develop ARDS criteria and need intubation within 7 days of admission to hospital.

Number of subjects: 200 (20+180)

Investigational product: Hyperbaric oxygen (HBO) compared with best practice treatment HBO: HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments first 7 days Control: Best practice treatment for COVID-19

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Study Start: 2020-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

1. ARDS/pneumonia caused by other viral infections (positive for other virus)
2. ARDS/pneumonia caused by other non-viral infections or trauma
3. Known pregnancy or positive pregnancy test in women of childbearing age
4. Patients with previous lung fibrosis more than 10%
5. CT- or Spirometry-verified severe COPD with Emphysema
6. Contraindication for HBO according to local guidelines
7. Not likely to need ICU admission < 7 days of screening (Subjective criteria that may exclude any patients that fulfil the other inclusion criteria but where the treating physician suspect a spontaneous recovery)
8. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
9. Prisoner (Exclusion criteria according to IRB at UCSD)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen	Hyperbaric oxygen	Hyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice

Primary Outcome Measures

Name	Time	Method
ICU admission	Through study completion 30 days	The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen \>40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) \> 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU

Secondary Outcome Measures

Name	Time	Method
Time-to-intubation	Through study completion 30 days	Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30
Time-to-ICU	Through study completion 30 days	Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.
30-day mortality	Through study completion 30 days	Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.
Inflammatory response	Through study completion 30 days	Mean change in inflammatory response from day 1 to day 30.; 1. White cell count + differentiation; 2. Procalcitonin; 3. C-Reactive protein; 4. Cytokines (IL-6) (if available at local laboratory); 5. Ferritin; 6. D-Dimer; 7. LDH
Overall survival	Through study completion 30 days	Overall survival (Kaplan-Meier)

Trial Locations

Locations (3)

Blekingesjukhuset; 🇸🇪 Karlskrona, Blekinge, Sweden

Krankenhaus St. Joesf; 🇩🇪 Regensburg, Germany

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden