COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04534478

Maria-Jesus Cruz, PhD

mj.cruz@vhir.org

2020-09-01

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - patients over 18 years of age - diagnosis of covid-19 pneumonia that would have required hospital admission - post covid-19 organized pneumonia diagnosis - without any contraindication to the study drug - that, adequately informed, voluntarily agree to participate in the study after knowing its objectives and risks and grant their written consent.

- they do not authorize their participation - patients with contraindications to receiving treatment with corticosteroids - impossibility of understanding the requirements of the study, in the opinion of the researcher. - expected survival less than the duration of the study in the opinion of the investigator. - clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection and / or cellulitis. - patient who receives a lung transplant during the study period. - impossibility of carrying out lung function studies. - poorly controlled diabetes mellitus (glycosylated hb> 10%). - pregnancy or breastfeeding - they are participating in another intervention study

2

Hospital Universitari Vall d'Hebron Research Institute

18

100

None

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

Change in pulmonary diffusion.

None

Phase 4

[{"arm_notes": "Less intensive regimen", "treatment_id": 1021, "treatment_name": "Prednisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Standard regimen", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]