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IRCT20080901001165N60 IRCT 2020-05-28 Bagheiat-allah University of Medical Sciences Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19 Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19 2020-05-14 anticipated 30 Complete https://irct.ir/trial/48102 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention, Blinding description: this is a double-blinded clinical trial, in which, a completely similar placebo to the drug is given to the main researcher by the manufacturer, and the drug and the placebo are distinguished only by the code that only the original researcher knows about. The doctor and the patient will be unaware of the drug/placebo product. The results will be recorded in the checklist based on the code registered on the drug and the analysis will be done based on the codes. At the end of the study, the meaning of each code will be determined. 3 COVID-19. Intervention 1: Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.). 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 The data release schedule is still unclear.
public Seyed Hasan Saadat
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 saadat350@gmail.com Bagheiat-allah University of Medical Sciences scientific Yunes Panahi
Baqiyatallah university of medical science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 Yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms. 18 years 65 years Both History of allergy to the ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit; Pregnancy; Lactation. Impossibility of oral nutrition; U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.) Clinical symptoms (dry cough). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire. Clinical symptoms (respiratory distress). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device. Clinical symptoms (fever). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Thermometer. Ferritin level. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Blood sample, laboratory analysis. Serum level of Interleukin 6. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Elisa kit. Serum level of tumor necrosis factor(TNF) alfa. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Elisa kit. Serum level of Monocyte chemoattractant protein-1(MCP-1). Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Elisa kit. Quality of life. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: The 36-Item Short Form Survey (SF-36) questionnaire. Mood. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Profile of Mood States(POMS) questionnaire. Anxiety. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Perceived Stress Scale (PSS) questionnaire. C-reactive protein (CRP) level. Timepoint: Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist. Method of measurement: Blood sample, laboratory analysis. Takgen company Bagheiat-allah University of Medical Sciences Baqiyatallah University of Medical Science Approved 2020-05-02 Ethics committee of Baqiyatallah Medical Sciences University Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)