Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT04327505
Status:
TERMINATED
Last Update Posted:
2023-01-09
First Post:
2020-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility, change of disease due to virus mutations and/or vaccination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-19-HBO
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: