COVID-19 trials registries data warehouse

 Return to trial list

Trial - IRCT20220418054581N1


Column Value
Trial registration number IRCT20220418054581N1
Full text link
Last imported at : June 12, 2022, 5:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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"}]