The effect of L-carnitine supplementation on mortality and serum levels of C-reactive protein in obese patients with coronavirus (nCov-2019) with acute respiratory failure admitted to intensive care unit

The effect of L-carnitine supplementation on mortality and serum levels of C-reactive protein in obese patients with coronavirus (nCov-2019) with acute respiratory failure admitted to the intensive care unit

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. Numbers in closed envelopes were used for randomization.

A total of 40 adult patients with acute coronavirus-induced respiratory infection admitted to the Army Hospital ICU referred by an Intensive Care Specialist will be enrolled in the study after obtaining informed consent to participate in the study. Entry of each patient into the case or control group will be random and with the help of numbers in closed envelopes. Commercial L 3-carnitine capsule supplement with a dose of 3000 mg and starch as a placebo that is randomly packed and covered (blinding) is gavaged to patients for 7 days.

Obese men and women; over the age of 18; with acute respiratory failure due to coronavirus; hospitalized in the intensive care unit; individuals who wish to participate if they have no history of liver or kidney disease and are not pregnant or breastfeeding.

Oral supplement with a high dose of L- carnitine (3000 mg) in patients with acute coronavirus-induced respiratory infection in the intensive care unit

Evaluation of ICU mortality, 28-day mortality, serum level of acute-phase reactive protein CRP, the ratio of serum level of acute-phase reactive protein level C to albumin, the number of ventilator-dependent days

In order to increase the accuracy of the study and improve its design, according to the suggestions of clinical guidance professors, the present plan was updated.

After admitting the patient to the intensive care unit and obtaining the eligible criteria for inclusion in the study, individuals were randomly assigned envelopes containing unique codes generated by the standard site (www.sealedenvelope.com). Codes with groups (A and B) were initially produced by one of the project facilitators who is not involved in any clinical phases of intervention and sampling and will remain with them until the end of the study and other researchers until the end of the study of the concept of codes and the groups will remain uninformed. On the envelopes, only the codes A or B are inserted to specify two separate groups. After assigning each envelope to the patient admitted to the study, the envelope is opened and the code inside the envelope, which contains two letters and a number (for example, XY3), which has no meaning and does not indicate any meaning, and is completely random, will be inserted on the supplement box. Patients are only classified according to code A or B, and the numbers in the envelope are not a criterion for classification or indication of belonging to a specific group. These codes are used only for labeling on medicine and placebo BOXS.

The drugs and placebos in this study are exactly the same. In the present study, L-carnitine and placebo capsules are produced in exactly the same volume, color, odor, and size and are provided to the nurse or nutritionist in the same package. All researchers conducting the study, nurses, physicians, and data collectors will be kept blind to the type of supplements and groups assigned. As each patient enters the study, an envelope containing the code is randomly selected, and after opening the envelope, the code inside it is recorded on the supplement box of the same group as the code on the envelope and is assigned to the patient. Therefore, before and after selecting the patient, none of the researchers and the clinical team will be aware of the type of supplement the patient is receiving.After assigning a supplement or placebo to the patient, the nurse dissolves the supplements or placebo in 30 cc of water and feeds the patient every 8 hours through a nasogastric tube. For this reason, the nurse, physician, and patient will not be informed of the type of supplement or placebo received during the study.