| Trial registration number
|
NCT04355637 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04355637
|
First author
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov
|
Alvar Agusti
|
Contact
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov
|
aagusti@clinic.cat
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-04-21
|
Recruitment status
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
multi-center
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- covid19 positive
- hospitalized because of pneumonia (status #3 - #4 world health organization (who)
scale)
- without contraindications to receive study treatment
- informed consent
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
- receiving corticoids (inhaled or systemic)
- receiving anti interleukin-1 (il-1) or anti-il-6 drugs
- receiving high flow oxygen therapy
- receiving mechanical ventilation
- pregnancy
- participating in another intervention trial for covid19
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Sara Varea
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
79
|
Countries
Last imported at : Jan. 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Argentina;Spain
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Moderate disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
3: Moderate disease at enrollment
|
Total sample size
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov
|
120
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Proportion of patients in both arms fulfilling the criteria for treatment failure
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 4
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|