Protocol summary
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Study aim
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Determining the Effectiveness of L-carnitine Supplementation on Clinical Outcomes in Hospitalized COVID-19 Patients
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Design
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This clinical trial has two intervention and control groups, which are a total of 64 patients and are randomly divided into two groups. This study is a phase 3 clinical trial and is parallel and not-blinded.
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Settings and conduct
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This study is a clinical trial conducted in Shahid Beheshti Hospital in Hamadan at 2020. Patients who are admitted according to the inclusion criteria in this study are randomly divided to the intervention or control group. The control group will receive only routine medications and the intervention group will receive L-carnitine supplements in addition to these medications.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Age 18 to 60 years؛ Positive PCR test؛ Hospitalization؛ Presence of Symptoms According to the Instructions of the Ministry of Health؛ Mild to moderate disease
Exclusion Criteria: Pregnancy؛ Lactation؛ Severe Cardiovascular Disease؛ HIV Infection؛ History of Taking L-carnitine Supplement in the Past Month
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Intervention groups
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Patients in both intervention and control groups are routinely treated for COVID-19 according to the protocol of the Food and Drug Administration, but in addition to these routine drugs, the intervention group will receive 3 grams of L-carnitine supplement daily for 5 days.
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Main outcome variables
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Evaluation of clinical consequences of L-carnitine such as inflammatory factors like CRP, ESR and other factors such as ALT, AST, LDH, CPK, WBC, PT, INR and other
General information
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Reason for update
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Reduce the number of statistical samples according to the circumstances؛
Eliminate numbers of primary outcome variables
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200921048794N1
Registration date:
2020-11-19, 1399/08/29
Registration timing:
prospective
Last update:
2021-01-09, 1399/10/20
Update count:
1
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Registration date
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2020-11-19, 1399/08/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-19, 1399/12/01
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Expected recruitment end date
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2021-06-21, 1400/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the Effects of L-carnitine Supplementation on Clinical Outcomes in Hospitalized Patients with COVID-19
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Public title
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Evaluation of the Effects of L-carnitine Supplementation on Patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 60 years
Positive PCR Test
Hospitalization
Existence of Corona Virus Symptoms According to the Instructions of the Ministry of Health
Mild to Moderate Disease Severity
Exclusion criteria:
Pregnancy
Breastfeeding
Severe Cardiovascular Disease
HIV Infection
History of Taking L-carnitine Supplementation in the Past Month
Requires Care in the ICU
Taking Anti-Inflammatory Drugs out of the Medication Regimen
Patients with High and Critical Disease Severity
Patient Dissatisfaction to Enter the Plan
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We put 2 sheets A and two sheets B in an envelope and each time we remove one of the sheets, we place the patient in the control or intervention group. The removed sheet will not be returned to the envelope until the all of sheets in the envelope be finished. After randomly pulling out all four sheets, all sheets are returned to the envelope and the above procedure will be continued for the next four patients until the desired sample size is reached.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-24, 1399/08/03
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Ethics committee reference number
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IR.UMSHA.REC.1399.650
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, Virus identified
Primary outcomes
1
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Description
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C-Reactive Protein (CRP)
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Timepoint
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At the Beginning of Intervention (the Zero day) and the End of Intervention (Fifth day )
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Method of measurement
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Blood test
2
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Description
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Erythrocyte Sedimentation Rate (ESR)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
3
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Description
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O2 Saturation
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Pulse Oximeter
4
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Description
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Complete Blood Count (CBC)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
5
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Description
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White Blood Cell (WBC)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
6
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Description
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Alanine Aminotransferase (ALT)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
7
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Description
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Lactate Dehydrogenase (LDH)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
8
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Description
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Creatine Phosphokinase (CPK)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
9
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Description
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Creatinine
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
10
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Description
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Urea
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
11
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Description
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Prothrombin Time (PT)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
12
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Description
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Red Cell Distribution Width (RDW)
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Blood test
Secondary outcomes
1
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Description
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Fever
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Patient File
2
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Description
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Cough
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Questionnaire
3
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Description
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Mortality Rate
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Timepoint
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During the intervention
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Method of measurement
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Death of the Patient
4
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Description
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Duration of Hospitalization
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Timepoint
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Beginning and End of the Intervention
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Method of measurement
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Days
5
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Description
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ICU Referral
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Timepoint
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During the Intervention
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Method of measurement
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Observational
6
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Description
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Requires Ventilation
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Timepoint
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During the Intervention
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Method of measurement
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Observational
Intervention groups
1
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Description
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Control group: This hospitalized group receives only their routine medication regimen which includes Dexamethasone, Interferon beta and Favipiravir.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: The intervention group in addition to their usual treatment regimen received 1000 mg L-carnitine tablets of Karen Company for 5 days and 3 g daily, three oral tablets daily.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available