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IRCT20201024049134N4 IRCT 2021-10-21 Babol University of Medical Sciences The Efficacy of dimethyl fumarate in the treatment of patients with COVID-19 The Efficacy of standard treatment and dimethyl fumarate in the treatment of patients with COVID-19 2021-11-20 anticipated 30 Complete https://irct.ir/trial/59456 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit randomization is done by block method with a block size of 4. For each of the 6 possible scenarios for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6). With the help of a dice, the numbers between 1 and 6 are selected, and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence. Inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written is provided to the executor with the condition that the boxes are completely sealed. Finally, the researcher assigns patients to the standard intervention and treatment group based on patients' admission orders. Tools: Create random sequences of 4 random blocks Concealment to execute random sequences on study participants will be done. How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher, Blinding description: In this study, participants (patients), clinical caregivers, and a group of researchers in charge of implementing the protocol will be blinded. Due to the similar appearance and use of the drug under study and placebo, these people can not distinguish them. 2-3 COVID-19. Intervention 1: Control group: Patients in this group receive placebo capsules (capsules containing wheat flour) daily for 5 days (a total of 5 capsules per patient). Also, in this group, in addition to placebo capsules, people will be prescribed drugs listed in the national protocol for treating hospitalized patients with Covid-19 (including corticosteroids and remdesivir). Intervention 2: Intervention group: Patients in this group receive dimethyl fumarate 240 mg capsules (CinnaGen, Tehran, Iran) daily for 5 days (a total of 5 capsules per patient). Also, in this group, in addition to dimethyl fumarate capsules, the drugs listed in the national protocol for treating hospitalized patients with Covid-19 (including corticosteroids and remdesivir) will be administered. Yes - There is a plan to make this available What will be shared: All participants' personal data can be shared after the anonymization of individuals. When: Six months after the end of the study and publication of the article To whom: The data of this study will be available only to researchers working in academic and scientific institutions. Conditions: There are no specific preconditions. Where to obtain: They should send their request to the person in charge of the study, Dr. Mostafa Javanian, with the e-mail address: mjavanian@gmail.com How to obtain: On average, it will take two weeks to process the application. Comments:
public Mohammad Barary
No. 88, Khosravan ave., Moallem 12 st., Shariaty blvd.
Babol Iran (Islamic Republic of) 4714743568 +98 11 3236 0124 m.barary@mubabol.ac.ir Babol University of Medical Sciences scientific Mostafa Javanian
Vice-Chancellor for public health affairs, Shahid Modarres blvd.
Babol Iran (Islamic Republic of) 4714934937 +98 11 3233 6875 mjavanian@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Men and women of at least 18 years of age capable of providing informed consent Confirmation of COVID-19 with RT-PCR Need for hospitalization No need for mechanical ventilation No need to more than 10 L/min of supplemental oxygen by any device. The patient must meet at least one of the following high-risk criteria: age 70 years or older, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled blood pressure (systolic blood pressure> 150 mm Hg), history of respiratory disease (Including asthma or COPD), history of heart failure, history of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of referral, Bicytopenia, Pancytopenia, or a combination of neutrophilia and lymphopenia 18 years no limit Both History of allergy to dimethyl fumarate Use of dimethyl fumarate before current hospitalization Patients more than 70 years of age with a history of any of the following in the last six months: Class III / IV Heart Failure Based on the New York Heart Association (NYHA) classification, Insulin-dependent diabetes, Angina pectoris, Malignancy Uncontrolled bacterial, fungal, or viral infection (other than COVID-19). Any history of receiving convalescent plasma therapy Absolute neutrophil count (ANC) < 500 Platelets count < 50,000 Pregnant women or those intending to become pregnant Breastfeeding women AST or ALT > 5 times the upper limits of normal (ULN) Estimated glomerular filtration rate (eGFR) < 30 ml/min in 1.73 m2 using MDRD equation U07.1 COVID-19, virus identified Placebo Treatment - Drugs Control group: Patients in this group receive placebo capsules (capsules containing wheat flour) daily for 5 days (a total of 5 capsules per patient). Also, in this group, in addition to placebo capsules, people will be prescribed drugs listed in the national protocol for treating hospitalized patients with Covid-19 (including corticosteroids and remdesivir). Intervention group: Patients in this group receive dimethyl fumarate 240 mg capsules (CinnaGen, Tehran, Iran) daily for 5 days (a total of 5 capsules per patient). Also, in this group, in addition to dimethyl fumarate capsules, the drugs listed in the national protocol for treating hospitalized patients with Covid-19 (including corticosteroids and remdesivir) will be administered. Need for mechanical ventilation. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. Death. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. Severely ill. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. Cessation of fever. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team. Improve ESR, CRP, and CBC test results. Timepoint: 30 days after the start of the intervention. Method of measurement: Interpretation of paraclinical tests' results. Negative RT-PCR test. Timepoint: 30 days after the start of the intervention. Method of measurement: RT-PCR test. Improve oxygen saturation. Timepoint: 30 days after the start of the intervention. Method of measurement: Pulse oximeter. Improve pulmonary involvement on CT scan. Timepoint: 30 days after the start of the intervention. Method of measurement: Chest CT scan. Babol University of Medical Sciences Approved 2021-10-04 Research Ethics Committees of Babol University of Medical Sciences GanjAfrooz Blvd. Babol Mazandaran Iran (Islamic Republic of)