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| Name | Class |
|---|---|
| Da Vinci Clinic | UNKNOWN |
| HGC Rijswijk | UNKNOWN |
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The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.
The main questions it aims to answer are:
Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen therapy | Experimental | 40 sessions of HBOT at 2.4 ATM |
|
| Standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen | Drug | Hyperbaric oxygen therapy (2.4 ATA, 40 sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical and mental component scores of the 36-item Short Form Survey (SF-36) | Range 0-100, with higher scores indicating higher quality of life | Week 20 (i.e. 3-months after end of HBOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Euroqol-5D (EQ-5D) | Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life) | Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment). |
| Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Da Vinci Clinic | Amersfoort | Netherlands | ||||
| Da Vinci Clinic |
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Randomized controlled trial comparing HBOT to standard care alone, with a cross-over from standard care to HBOT in case primary outcome is positive after 6 months follow-up.
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| Worn continuously until week 34 |
| Biochemical parameters | Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment) |
| Absence from work | Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment). |
| Cost-effectiveness | Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment). |
| Geldrop |
| Netherlands |
| Da Vinci Clinic | Hoogeveen | Netherlands |
| HGC Rijswijk | Rijswijk | Netherlands |
|
| Da Vinci Clinic | Rotterdam | Netherlands |
|
| Erasmus MC | Rotterdam | Netherlands |
|
| Da Vinci Clinic | Waalwijk | Netherlands |
|
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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