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IRCT20150623022884N3 IRCT 2020-11-18 Kermanshah University of Medical Sciences MAB98 for treatment of Covid-19 Evaluation of therapeutic effect of MAB98 including thymolic fraction of Trachyspermum ammi, thymoquinone fraction of Nigella sativa and colchicine of Colchicum autumnale in covid 19 patients 2020-04-08 anticipated 120 Complete https://irct.ir/trial/49249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted balanced ‎block randomization method: In this study permuted balanced ‎block randomization will used. It is recommended to use in small randomized control trials when we want treatment groups of equal sizes. In this permuted balanced ‎block randomization, the blocked size is 4, the allocation ratio is 1 and number of intervention groups is 2. After specifying the block size, all the potential contribution of the assignments within each group must be calculated, and then the blocks are randomly chosen to determine the assignment of all participants. So, the total of sample size of participants randomized to two treatment groups, a randomized block method would be: block size is four, possible balance combinations with two intervention group I and two intervention group II in each block are calculated as 6 and where each block is randomly chosen to determine the assignment of all samples. Finally, 30 blocks with random permutation will be generated. 2 Coronavirus disease 2019 (COVID-19). Intervention 1: Intervention group: Patients diagnosed with COVID-19 who receiving the standard care including Kaletra or hydroxychloroquine, naproxen and other accessory drugs as well as MAB98 including 125 and 250 mgr capsules received 2 and 3 times daily, respectively for 6 (outpatients) or 12 days (inpatients). MAB98 consisting of extracted colchicine-rich fraction of Colchicum autumnale, as well as thymoquinone and thymol rich fractions of Nigella Sativa and Trachyspermum Ammi respectively which their effective components have been extracted through alcoholic and water extraction. MAB98 was manufacture in the Zist Tolid Razi Co. Intervention 2: Control group: Patients diagnosed with COVID-19 who receiving standard care including Kaletra or hydroxychloroquine, naproxen and other accessory drugs. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the possible miss-use of the data provided in this study as a sample group of COVID-19 patients in Kermanshah, the primary data of the patients would be kept confidential.
public Ali Mostafaie
Parastar Blvd-Medical School-Medical Biology Research Center
Kermanshah Iran (Islamic Republic of) 67145-1673 +98 83 3427 9923 amostafaie@kums.ac.ir Kermanshah University of Medical Sciences scientific Ali Mostafaie
Parastar Blvd-Medical School-Medical Biology Research Center
Kermanshah Iran (Islamic Republic of) 67145-1673 +98 83 3427 9923 amostafaie@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chest CT scan/RT-PCR for Covid19 Clinical signs for Covid19 10 years no limit Both Age lower than 10 years pregnancy Sever hepatic disorder U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: Patients diagnosed with COVID-19 who receiving the standard care including Kaletra or hydroxychloroquine, naproxen and other accessory drugs as well as MAB98 including 125 and 250 mgr capsules received 2 and 3 times daily, respectively for 6 (outpatients) or 12 days (inpatients). MAB98 consisting of extracted colchicine-rich fraction of Colchicum autumnale, as well as thymoquinone and thymol rich fractions of Nigella Sativa and Trachyspermum Ammi respectively which their effective components have been extracted through alcoholic and water extraction. MAB98 was manufacture in the Zist Tolid Razi Co. Control group: Patients diagnosed with COVID-19 who receiving standard care including Kaletra or hydroxychloroquine, naproxen and other accessory drugs. Fatality rate. Timepoint: Since admission to 14th day after discharge. Method of measurement: Evaluation of vital signs (pulse rate and active ECG). Hospitalization duration. Timepoint: Since admission to discharge. Method of measurement: Days of hospitalization. Need of intensive care unit (ICU) admission. Timepoint: Admission to discharge. Method of measurement: This is a clinical judgment by the clinicians. In any case with unstable situation (such as ARDS) the patient must be admitted to ICU for a better care. NCT04392141 ClinicalTrials.gov Zist Tolid Razi Company Approved 2021-03-03 Ethics Ccommittee of Kermanshah University of Medical Sciences Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard Kermanshah Kermanshah Iran (Islamic Republic of)