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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04854941 |
|
Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-04-22 |
|
Recruitment status
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - patients with covid-19 infection confirmed by polymerase chain reaction of nasopharyngeal and oropharyngeal swabs to the causative agent of this infection - age from 18 to 75 years old from december 2020 to april 2021 |
|
Exclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- the patient's decision to withdraw from the study - refusing to take the probiotic for a reason not related to the development of side effects. non-inclusion criteria: - age over 75 years old or under 18 years old, - taking probiotics for 3 months prior to admission - history of intolerance to probiotics or their components - refusal to participate and sign informed consent - pregnancy or breastfeeding - presence of cancer or psychoemotional disorders - renal failure at the time of admission (glomerular filtration rate less than 50 ml / min) - hepatic failure at the time of admission (equivalent to cirrhosis class b or c on the child-pugh scale) |
|
Number of arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
I.M. Sechenov First Moscow State Medical University |
|
Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
75 |
|
Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Russia |
|
Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
200 |
|
primary outcome
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Mortality |
|
Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "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"}] |