NCT05715801

Brief Summary

COVID-19 has swept the world, and while some people may experience long-term cognitive decline as a result of infection, no effective treatment has been announced. The primary goal of this study was to determine the efficacy of hyperbaric oxygen therapy in patients with SARS-CoV-2 infection, as well as to assess the effect of hyperbaric oxygen therapy on brain function in patients with COVID-19-related cognitive decline. In this study, approximately 80 people were randomly assigned to either hyperbaric oxygen or regular oxygen therapy to compare the effects of these two treatments on disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 1, 2023

Last Update Submit

February 6, 2023

Conditions

Cognitive DeclineCOVID-19SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (1)

  • scores of Montreal Cognitive Scale (MoCA)

    The total score is 30 points, and the cut-off value for MCI is identified:≤19 points(illiterate and primary school group);≤22 points(Middle school group); ≤24 points(University group).

    The patients would be followed up for 3 months after oxygen therapy.

Secondary Outcomes (7)

  • Quantitative Electroencephalography

    The patients would be followed up for 3 months after oxygen therapy.

  • Brain magnetic resonance imaging (MRI), brain functional magnetic resonance imaging (fMRI)

    The patients would be followed up for 3 months after oxygen therapy.

  • Boston naming test

    The patients would be followed up for 3 months after oxygen therapy.

  • auditory verbal learning test，AVLT

    The patients would be followed up for 3 months after oxygen therapy.

  • The Shape Trail Making Test A and B(STT-A&B)

    The patients would be followed up for 3 months after oxygen therapy.

  • +2 more secondary outcomes

Study Arms (2)

hyperbaric oxygen therapy

EXPERIMENTAL

Ten sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment.

Procedure: hyperbaric oxygen therapy

conventional oxygen therapy

ACTIVE COMPARATOR

Ten sessions of conventional oxygen therapy were completed within 4 weeks after enrollment.

Procedure: conventional oxygen therapy

Interventions

hyperbaric oxygen therapyPROCEDURE

The hyperbaric oxygen group was given 60 minutes of pure oxygen under 2ATA (Atmosphere Absolute, ATA) and 5 minutes of rest in between.

hyperbaric oxygen therapy
conventional oxygen therapyPROCEDURE

Conventional oxygen therapy group breathed 27% oxygen at 1.03 ATA for 60 minutes. (The chamber pressure was increased to 1.2ATA with circulating air noise for the first 5 minutes of the experiment, then reduced to 1.03 ATA for the next 5 minutes.)

conventional oxygen therapy

Eligibility Criteria

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

You may qualify if:

  • Out-patients 4 weeks after the diagnosis of SARS-CoV-2 infection
  • Subjective cognitive decline after SARS-CoV-2 infection
  • SARS-CoV-2 nucleic acid/antigen test negative.

You may not qualify if:

  • Contraindications to hyperbaric oxygen therapy
  • Cognitive decline can be explained by other diseases
  • Conditions that researchers consider unsuitable for clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Cognitive DysfunctionCOVID-19

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Jiannong Wu, M.D.

    First Affiliated Hospital of Zhejiang Chinese Medical University

    STUDY CHAIR

Central Study Contacts

Yan Jiang, M.D.

CONTACT

13575757710jiangyan@zcmu.edu.cn

Shan Liu, M.M.

CONTACT

18806715135graystar92@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 8, 2023

Study Start

January 29, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

CN(1)