| Trial registration number
|
NCT05175833 |
Full text link
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT05175833
|
First author
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Pedro Corazza, PhD
|
Contact
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
2022-01-04
|
Recruitment status
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
patients hospitalized in the icu with severe acute respiratory syndrome
progressive deterioration of the ventilatory status in the first 48 hours in the icu, which may require mechanical ventilation within this period;
confirmed diagnosis of covid-19 within 3 days of icu admission;
acceptance to participate.
|
Exclusion criteria
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov
|
relevant immunodeficiency (decompensated hiv, aggressive immunosuppression, terminal cancer)
decompensated systemic disease before the onset of covid-19.
|
Number of arms
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Universidade de Passo Fundo
|
Inclusion age min
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Brazil
|
Type of patients
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Critical disease at enrollment
|
Severity scale
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
70
|
primary outcome
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Secondary bacterial pneumonia
|
Notes
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
Phase 2
|
Arms
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "oral gel", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "oral gel", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|