Trial registration number
|
IRCT20220418054581N1 |
Full text link
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/63056
|
First author
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Saeid Hadi
|
Contact
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
hadiv941@mums.ac.ir
|
Registration date
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2022-06-11
|
Recruitment status
Last imported at : Dec. 21, 2022, 8:23 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Aug. 14, 2022, 8 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients over 18 years
Diagnosis of clinical and laboratory signs of severe Covid-19
Body mass index above 29.9 kg per square meter based on the weight in the file
Completion of the informed consent form by the patient or his / her legal guardian
Severe COVID-19 patients who are admitted to the medical ICU (MICU) and will require respiratory support
Patients with normal GI function who receive enteral feeding
|
Exclusion criteria
Last imported at : Aug. 14, 2022, 8 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Receive any L-carnitine supplement in the last 6 months
Participate in any other research project
History of liver and kidney disease
Pregnancy and lactation
Any allergy to L-carnitine
Patients who stayed in the ICU for < 72 hours
Patients who receive parenteral nutritional support
Patients treated with different drug regimens from the routine ICU protocol
Patients will be ongoing treatment with cisplatin, phenobarbital, phenytoin, pivalic acid, valproic acid, ifosfamide, and levetiracetam
Any gastrointestinal disorders that lead to stopping enteral feeding for more than 48 hours
|
Number of arms
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Artesh University of Medical Sciences
|
Inclusion age min
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
|
primary outcome
Last imported at : Aug. 14, 2022, 8 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
28 days mortality
Serum level of acute phase reactive protein C
Ratio of serum level of acute phase C-reactive protein to albumin
ICU mortality
The number of ventilator-dependent days
|
Notes
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Aug. 14, 2022, 8 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 720, "treatment_name": "L-carnitine", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|