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IRCT20081019001369N5 IRCT 2020-04-26 Mashhad University of Medical Sciences Effect of lithium carbonate on COVID-19 Clinical trial of lithium in improving the clinical and laboratory symptoms of patients with COVID-19 2020-05-02 anticipated 40 Complete https://irct.ir/trial/47141 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in three stages: 1- Random sequence generation: this step simple or limited randomization will be done based on a table of random numbers 2- Allocation concealment: which is done in the form of coded boxes (numbered drug containers) with a random sequence. In this method, a number of boxes with the same shape and size are numbered based on random sequences and contain drugs or placebo that have a completely similar appearance. 3- Execution of random allocation process: A: Identify the person who creates the random sequence B: A person who evaluates and registers researchers in terms of inclusion and exclusion criteria C: The person who assigned the participants to the groups: infectious diseases specialist The main researcher of the project, who creates a random sequence, does not interfere in other stages of randomization, including registration and allocation of participants, and the person involved in creating a random program is separate from other researchers, Blinding description: The drug and placebo are given as a same-color and –size tablets in boxes labeled with the letters A and B in box. The medical staff, the patient and the data collector are not aware of the nature of the drug or placebo, and only the executor of research project is aware of the nature of the contents of the two kind of tablets. 2 covid-19. Intervention 1: Intervention group: In addition to the standard treatment regimen for COVID-19, the lithium carbonate tablets (300 mg/day to 900 mg/day) will be given for 2 weeks. Intervention 2: Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo tablets once a day for 2 weeks. The placebo is formulated in tablets of the same shape and size as the drug tablets and contains inert agents. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is not clear yet
public Hossein Hosseinzadeh
Blv. Vakilabad2-School of Pharmacy, 1365-91775
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1193 hosseinzadehh@mums.ac.ir Mashhad University of Medical Sciences scientific Hossein Hosseinzadeh
Blv. Vakilabad2-School of Pharmacy, 1365-91775
mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1193 hosseinzadehh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with covid-19 symptoms Indication of home quarantine outpatients aged range 18-65 uears old 18 years 65 years Both Patients connected to acatheter or under chemotherapy Patients taking cytotoxic drugs or corticosteroids Patients having a psychological problem now or in the past or with a history of psychological problem in first class family Patients who used cigarette at least one month before the study U07.1 COVID-19 Disease Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard treatment regimen for COVID-19, the lithium carbonate tablets (300 mg/day to 900 mg/day) will be given for 2 weeks. Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo tablets once a day for 2 weeks. The placebo is formulated in tablets of the same shape and size as the drug tablets and contains inert agents. Time interval until clinical symptoms improve. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: time of recovery. Fever. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: Thermometer. Lymphopenia. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: Cell counter device. CRP. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: CRP kit. Mashhad University of Medical Sciences Approved 2020-04-23 Medical Ethics Committee of Mashhad University of Medical Sciences Blv.Vakilabad 2- School of Pharmacy-1365-91775 Mashhad Razavi Khorasan Iran (Islamic Republic of)