COVID-19 trials registries data warehouse

http://www.drks.de/DRKS00023971

Elisabeth Balint

elisabeth.balint@uni-ulm.de

2021-02-02

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

- SARS-CoV-2-infected patients hospitalized in normal wards (Not ICU) with a maximum moderate degree of disease according to RKI/WHO definition (see first exclusion criterion)- Age min. 18 years- Able to give informed consent at the time of study inclusion

- severe covid pneumonia with fever and bilateral lung infiltrates and respiratory rate>30/min or SpO2<90% on room air (adapted from RKI/WHO)- Condition after surgery/trauma/acute event (stroke, myocardial infarction, acute covid-independent infection) in the last 4 weeks- Known pregnancy - Patients with pre-existing pulmonary disease who were on oxygen prior to infection (e.g., due to pulmonary fibrosis, COPD)- limited ability to give consent (e.g. due to dementia)- limited ability to perform breathing maneuvers independently (e.g. high frailty)- limited ability to provide self-care (care level 2 or 3)- lack of language skills- seizures in the medical history

2

Klinik für Psychosomatische Medizin und Psychotherapie; Uniklinik Ulm

18

100

Germany

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

Course of inflammatory parameter IL-6 at admission (day 1) and bi-daily until discharge (average length of stay 10 days; i.e. 5 measurements on average)

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 230, "treatment_name": "Breathing exercise", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]