NCT04647656

Brief Summary

Post-COVID-19 syndrome is an assembly of symptoms, following an infection with Coronavirus disease 2019 (COVID-19). The syndrome is characterized by cognitive impairment, fatigue, sleep disorders, smell and taste disorders, pain and more. This long-term sequela can last for months after recovering from the virus, and no treatment is known to date. The aim of this study is to compare the effect of HBOT vs. Sham on post COVID-19 syndrome

Trial Health

77
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
20mo left

Started Jun 2023

Longer than P75 for not_applicable covid19

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 Progress64%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

November 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

November 29, 2020

Last Update Submit

April 16, 2026

Conditions

Covid19Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Cognitive health assessment (NeuroTrax)

    Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.

    Baseline, 2 months

Secondary Outcomes (15)

  • Brain perfusion

    Baseline, 2 months

  • Brain microstructure Brain microstructure

    Baseline, 2 months

  • Brain function imaging

    Baseline, 2 months

  • Post-COVID-19 symptom

    Baseline, 2 months

  • Quality of Life SF-36

    Baseline, 2 months, 1 year

  • +10 more secondary outcomes

Study Arms (2)

HBOT treatment group

ACTIVE COMPARATOR

40 daily hyperbaric oxygen treatment sessions will be administered 5 days per week

Device: Hyperbaric oxygen

HBOT sham group

SHAM COMPARATOR

40 daily Sham non-hyperbaric oxygen treatment will be administered 5 days per week

Device: Sham

Interventions

Hyperbaric oxygenDEVICE

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

HBOT treatment group
ShamDEVICE

Each session will include exposure of 90 minutes to 21% at 1.2 ATA during the first five minutes of the session with the noise of circulating air, and then decrease slowly during the next five minutes to 1.03 ATA

HBOT sham group

Eligibility Criteria

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

You may qualify if:

  • Age above 18 years
  • Reported post COVID-19 cognitive deterioration that effect quality of life and persist at least 3 months after confirmed infection.
  • Subject willing and able to read, understand and sign an informed consent

You may not qualify if:

  • Inability to attend scheduled clinic visits and/or comply with the study protocol
  • History of traumatic brain injury (TBI) or any other non COVID brain pathology
  • Active malignancy
  • Substance use at baseline
  • Severe or unstable physical disorders or major cognitive deficits at baseline
  • HBOT for any reason prior to study enrolment
  • Chest pathology incompatible with pressure changes (including moderate to severe asthma)
  • Ear or Sinus pathology incompatible with pressure changes
  • An inability to perform an awake brain MRI
  • Active smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh medical center

Ẕerifin, 70300, Israel

RECRUITING

Related Publications (6)

  • Stam HJ, Stucki G, Bickenbach J; European Academy of Rehabilitation Medicine. Covid-19 and Post Intensive Care Syndrome: A Call for Action. J Rehabil Med. 2020 Apr 15;52(4):jrm00044. doi: 10.2340/16501977-2677.

    PMID: 32286675BACKGROUND

  • Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

    PMID: 32644129BACKGROUND

  • Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.

    PMID: 32853602BACKGROUND

  • Tal S, Hadanny A, Berkovitz N, Sasson E, Ben-Jacob E, Efrati S. Hyperbaric oxygen may induce angiogenesis in patients suffering from prolonged post-concussion syndrome due to traumatic brain injury. Restor Neurol Neurosci. 2015;33(6):943-51. doi: 10.3233/RNN-150585.

    PMID: 26484702BACKGROUND

  • Boussi-Gross R, Golan H, Fishlev G, Bechor Y, Volkov O, Bergan J, Friedman M, Hoofien D, Shlamkovitch N, Ben-Jacob E, Efrati S. Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial. PLoS One. 2013 Nov 15;8(11):e79995. doi: 10.1371/journal.pone.0079995. eCollection 2013.

    PMID: 24260334BACKGROUND

  • Leitman M, Fuchs S, Tyomkin V, Hadanny A, Zilberman-Itskovich S, Efrati S. The effect of hyperbaric oxygen therapy on myocardial function in post-COVID-19 syndrome patients: a randomized controlled trial. Sci Rep. 2023 Jun 10;13(1):9473. doi: 10.1038/s41598-023-36570-x.

    PMID: 37301934DERIVED

MeSH Terms

Conditions

COVID-19Cognition Disorders

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Shai a Efrati, MD

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shani Zilberman-Itskovich, Dr.

CONTACT

97289979383shani.zilberman@mail.huji.ac.il

Shai Efrati, Prof.

CONTACT

efratishai@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 1, 2020

Study Start

June 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)