| Trial registration number
|
IRCT20220124053820N1 |
Full text link
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/65293
|
First author
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dr Alireza Seidavi
|
Contact
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
alirezaseidavi@yahoo.com
|
Registration date
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2022-09-19
|
Recruitment status
Last imported at : March 7, 2023, 12:05 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients who are hospitalization due to COVID-19. Patients should be 18 years old and older. Patients should have clinical symptoms and pneumonia of covid in chest radiography or CT scan. Patients should not particitaion in other clinical trials at the same time.
|
Exclusion criteria
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Number of arms
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Research deputy of Rasht Islamic Azad University and Zist Takhmir company
|
Inclusion age min
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
60
|
primary outcome
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Need to admission to ICU
Need to intubation
Mortality
Vital signs
Symptoms consisting cough, dyspnea, diarrhea, abdominal pain
O2 saturation
laboratories tests: Hb, Platelet, ESR, CRP, WBC, lymphocyce, NLR, CPK, ALT, AST, fibrinogen, D-dimer
Length of hospitalization
|
Notes
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 0
|
Arms
Last imported at : Sept. 19, 2022, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 710, "treatment_name": "Lactocare", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|