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The safety and efficacy of low-pressure hyperbaric oxygenation in participants with persistent positive SARS-CoV-2 PCR assay: An randomized, controlled, open-label, prospective trial

The safety and efficacy of low-pressure hyperbaric oxygenation in participants with persistent positive SARS-CoV-2 PCR assay: An randomized, controlled, open-label, prospective trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070773
Enrollment
Unknown
Registered
2023-04-23
Start date
2022-04-15
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

experimental group:micro-hyperbaric oxygen therapy + routine isolation course

Sponsors

Naval Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18~75 years old 2. Positive SARS-CoV-2 nucleic acid test 3. Nucleic acid test positive for 8 days or longer 4. Able to complete the operation of the micro hyperbaric chamber as required under guidance 5. No absolute contraindication to hyperbaric exposure 6. Sign the informed consent form

Exclusion criteria

Exclusion criteria: Patients with multiple rib fractures, severe and extensive chest wall contusions and untreated open chest wall trauma; (2) Tension pneumothorax and spontaneous pneumothorax in untreated patients; (3) Severe obstructive pulmonary emphysema patients; (4) Patients with uncontrolled acute respiratory obstruction; (5) Patients with active tuberculosis with cavity formation or still hemoptysis; (6) Patients with recently extracted teeth such as maxillary molars or cuspids; (7) Patients with purulent otitis media; (8) Non-congestive glaucoma patients; (9) Patients with retinal detachment; (10) Those with internal bleeding or uncontrolled bleeding disorders; (11) Untreated cancer patients. 2. Pregnant women. 3. Claustrophobic patients. 4. COVID-19 asymptomatic patients 5. Patients considered unsuitable for the trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Time of sarS-COV-2 nucleic acid test turning negative;

Secondary

MeasureTime frame
Viral load (CT value);Routine blood;Interleukin-1ß;Interleukin-6;C-reactive protein;TNF-a;D-dimer (D2D);Serum IgE;Serum IgG;Fatigue Self-Rating Scale for Fatigue;The Baker Anxiety Scale for anxiety;The Baker Depression Scale for depression;

Countries

China

Contacts

Public ContactYang Liu

Naval Medical Center of PLA

liuyang3722@163.com+86 13761105709

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026