| Trial registration number
|
IRCT20201229049872N1 |
Full text link
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/53333
|
First author
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Ebrahim Hazrati
|
Contact
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
info@ajaums.ac.ir
|
Registration date
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-04-22
|
Recruitment status
Last imported at : June 21, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with COVID-19 with moderate to severe respiratory failure admitted to ICU wards
|
Exclusion criteria
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Uncontrolled Diabetes Mellitus
Active bacterial or viral (viral Hepatitis and HIV) or fungal infection
Positive more than 0.5 Procalcitonin or positive bacterial and fungal culture of any specimen of body
Sever Electrolyte disturbance
History of severe reaction to Steroidal products
Active Gastrointestinal bleeding
|
Number of arms
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Artesh University of Medical Sciences
|
Inclusion age min
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
0
|
Inclusion age max
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
80
|
primary outcome
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Evaluation of the efficacy of colchicine plus methylprednisolone pulse therapy in treatment of Covid-19 patients with Respiratory distress
|
Notes
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 2/Phase 3
|
Arms
Last imported at : April 23, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 1961, "treatment_name": "Colchicine+methylprednisolone", "treatment_type": "Metabolic agents+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"}]
|