| Trial registration number
|
IRCT20210726051995N1 |
Full text link
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/57739
|
First author
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mojtaba Yousefi Zoshk
|
Contact
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
dr.yousefi.md@ajaums.ac.ir
|
Registration date
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-08-15
|
Recruitment status
Last imported at : Sept. 27, 2021, 4 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Diagnosed positive for Covid-19 based on PCR testing
Admitted in intensive care unit
Treated with remdesivir
|
Exclusion criteria
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Positive history of any underlying liver disease e.g. fatty liver, or acute or chronic hepaptitis
Plasma levels of liver transaminases over 100 IU/L on the first day of ICU admission
Simultaneous use of any hepatotoxic drugs
|
Number of arms
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Artesh University of Medical Sciences
|
Inclusion age min
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Critical disease at enrollment
|
Severity scale
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
88
|
primary outcome
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
the prevention of acute liver injury
|
Notes
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 18, "treatment_name": "Acetylcysteine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|