Hyperbaric oxygen therapy for long COVID (HOT-LoCO), an interim safety report from a randomised controlled trial.
Clinical trial
HBOT
HRQoL
Hyperbaric oxygen
Long COVID
Post COVID condition
RCT
Safety
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
20 Jan 2023
20 Jan 2023
Historique:
received:
12
07
2022
accepted:
10
01
2023
entrez:
20
1
2023
pubmed:
21
1
2023
medline:
25
1
2023
Statut:
epublish
Résumé
With ~ 50 million individuals suffering from post-COVID condition (PCC), low health related quality of life (HRQoL) is a vast problem. Common symptoms of PCC, that persists 3 months from the onset of COVID-19 are fatigue, shortness of breath and cognitive dysfunction. No effective treatment options have been widely adopted in clinical practice. Hyperbaric oxygen (HBO The objective of this interim analysis is to describe our cohort and evaluate the safety of HBO Twenty subjects were randomised, they had very low HRQoL compared to norm data. Mean (SD) PF 31.75 (19.55) (95% Confidence interval; 22.60-40.90) vs 83.5 (23.9) p < 0.001 in Rand-36 PF and mean 0.00 (0.00) in RP. Very low physical performance compared to norm data. 6MWT 442 (180) (95% CI 358-525) vs 662 (18) meters p < 0.001. 31 AEs occurred in 60% of subjects. In 20 AEs, there were at least a possible relationship with the study drug, most commonly cough and chest pain/discomfort. An (unexpectedly) high frequency of AEs was observed but the DSMB assessed HBO
Sections du résumé
BACKGROUND
BACKGROUND
With ~ 50 million individuals suffering from post-COVID condition (PCC), low health related quality of life (HRQoL) is a vast problem. Common symptoms of PCC, that persists 3 months from the onset of COVID-19 are fatigue, shortness of breath and cognitive dysfunction. No effective treatment options have been widely adopted in clinical practice. Hyperbaric oxygen (HBO
METHODS
METHODS
The objective of this interim analysis is to describe our cohort and evaluate the safety of HBO
RESULTS
RESULTS
Twenty subjects were randomised, they had very low HRQoL compared to norm data. Mean (SD) PF 31.75 (19.55) (95% Confidence interval; 22.60-40.90) vs 83.5 (23.9) p < 0.001 in Rand-36 PF and mean 0.00 (0.00) in RP. Very low physical performance compared to norm data. 6MWT 442 (180) (95% CI 358-525) vs 662 (18) meters p < 0.001. 31 AEs occurred in 60% of subjects. In 20 AEs, there were at least a possible relationship with the study drug, most commonly cough and chest pain/discomfort.
CONCLUSIONS
CONCLUSIONS
An (unexpectedly) high frequency of AEs was observed but the DSMB assessed HBO
Identifiants
pubmed: 36670365
doi: 10.1186/s12879-023-08002-8
pii: 10.1186/s12879-023-08002-8
pmc: PMC9854077
doi:
Banques de données
ClinicalTrials.gov
['NCT04842448']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
33Informations de copyright
© 2023. The Author(s).
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