E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiorgan symptoms after COVID-19 infection (Long COVID) |
Multiorgan-Symptome nach COVID-19 Infektion (Long COVID) |
|
E.1.1.1 | Medical condition in easily understood language |
Symptoms as breathing difficulties, fatigue and neuropathies in patients weeks to months after having contracted a COVID-19 infection. |
Symptome wie Atembeschwerden, Mattigkeit und Neuropathien bei Patienten Wochen bis Monate nach durchgemachter COVID-19 Infektion. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Biological Phenomena [G16] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms after having contracted a COVID-19 infection (i.e. "Long COVID"). |
Das Ziel dieser Studie ist es, die Machbarkeit, Sicherheit und Effektivität von hyperbarer Sauerstofftherapie bei Patienten mit Multiorgan-Symptomen nach durchgemachter COVID-19 Infektion zu untersuchen (d.h. "Long COVID"). |
|
E.2.2 | Secondary objectives of the trial |
Not applicable. |
Nicht zutreffend. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18-90 years - Persistent, predominantly pulmonary symptoms with no or little tendency for remission, necessitating in-patient treatment at rehabilitation unit. - No active COVID-19 disease (as documented by three subsequent negative PCR-tests at three days intervals). - Subject willing and able to read, understand and sign an informed consent and to do self-reporting according to questionnaire.
|
- Alter 18-90 Jahre - Persistierende, hauptsächlich pulmonale Symptome mit keiner oder nur minimaler Tendenz zur Remission, eine stationäre Behandlung in einer Rehabilitationseinheit benötigend. - Keine aktive COVID-19 Infektion (dokumentiert mittels dreier aufeinanderfolgender negativer PCR-Tests in einem dreitägigen Intervall) - TeilnehmerInnen können die Einwilligungserklärung lesen, verstehen und unterschreiben, und sind dazu fähig, selbstständig Fragebögen auszufüllen. |
|
E.4 | Principal exclusion criteria |
- Active malignancy - HBO-treatment for any reason prior to study enrolment - Chest pathology incompatible with pressure changes (including untreated pneumothorax, bullous emphysema, moderate to severe asthma) - Ear or sinus pathology incompatible with pressure changes - Pregnancy or lactation - Patients unable to give informed consent
|
- Aktive maligne Erkrankung - Frühere HBO-Behandlung jeglicher Ursache - Pathologien des Thorax, welche inkompatibel mit Druckänderungen sind (u.a. nicht behandelter Pneumothorax, bullöses Emphysem, moderates/schweres Asthma) - Ohren/Sinus-Pathologien die mit Druckänderungen inkompatibel sind - Schwangerschaft oder Stillzeit - Patienten, die selbst keine Einwilligung abgeben können |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility, safety and success of hyperbaric oxygen therapy in Long COVID patients as assessed via: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire - Pulse-oxymetry - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation |
Machbarkeit, Sicherheit und Effektivität hyperbarer Sauerstofftherapie bei Long COVID Patienten, analysiert anhand von: - Thoraxröntgen - Neurologischer Status - Laborparameter (inklusive Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 Antikörper) - SF-36 Fragebogen - Puls-Oxymetrie - Blutdruck - Herzschlag - Blutgase - Notwendigkeit der Sauerstoff-Supplementierung |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Before and at the end of treatment: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire 2. Before, after the 1st, after the 6th, and after the last treatment - Pulse Oxymetry 3. Regularly during HBO-treatment - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation |
1. Vor erster und nach Ende der letzten HBO-Behandlung: - Thoraxröntgen - Neurologischer Status - Laborparameter (inklusive Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 Antikörper) - SF-36 Fragebogen 2. Vor der ersten, nach der 6. und nach Ende der letzten HBO-Einheit - Puls-Oxymetrie 3. Regelmäßig während der HBO-Behandlungen - Blutdruck - Herzschlag - Blutgase - Notwendigkeit der Sauerstoff-Supplementierung |
|
E.5.2 | Secondary end point(s) |
Not applicable. |
Nicht zutreffend. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable. |
Nicht zutreffend. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |