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IRCT20200427047215N1 IRCT 2020-05-05 Isfahan University of Medical Sciences Vice Chancellor for Research and Technology Evaluation effect of Indomethacin for Covid19 infection Efficacy and safety of oral indomethacin for treatment of covid 19 induced pneumonia 2020-05-08 anticipated 60 Complete https://irct.ir/trial/47520 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: In this study, patients with admission conditions were divided into two groups. In addition to the usual treatment for coronavirus infection, the intervention group received 75 mg of indomethacin tablets daily for 5 consecutive days, but the control group received routine treatment for corona infection plus placebo, Randomization description: In this study, the random number table method is used for randomization.The randomization unit is also the individual.To read numbers, it is also from left to right.For concealment, the method of sequentially numbered, sealed, opaque envelopes is used, Blinding description: In this study, patients, the main researcher, the physician who visits patients daily for response to the treatment and examination of symptoms, and is responsible for collecting information, and the nursing staff are kept blind to the allocation of study groups.All patients are visited daily by one of the physicians of the treatment team who is in the process of intervention.However, the follow-up of the side effects of the drug and the evaluation of the course of treatment in patients will be performed by another physician, who is also in the general study constant.This physician will monitor the condition of patients at home for up to 4 weeks after discharge and will be completely blind. 2-3 Pneumonia induced by covid19. Intervention 1: Intervention group:ُُSlow release Indomethacin tablets, 75 mg daily for five days. Made by Aria Pharmaceutical Company. Intervention 2: Control group: A placebo similar to indomethacin tablets is given daily for five days. Yes - There is a plan to make this available What will be shared: All participants' data is shared after it becomes unrecognizable When: Data access starts immediately after printing the results To whom: The data in this study are only available to medical researchers Conditions: It is available for any analysis or use that aims to improve and progress in the treatment of covid19 infection Where to obtain: Contact email address:alidarakhshandeh@yahoo.com Phone call: 00989133817087 How to obtain: In case of requesting data for the study, the applicant must first introduce himself or herself and the relevant organization to determine the purpose of the data request and state for what purpose this data is used.After submitting the request, if the researchers of this study prove that the data of this study can advance the therapeutic goals, the information will be sent as long as the data remains confidential.This process takes two weeks. Comments:
public Ali Darakhshandeh
No 566A,13 Alley, Saadat Ave, Isfahan
Isfahan Iran (Islamic Republic of) 8174797677 98317771870 alidarakhshandeh@yahoo.com Esfahan University of Medical Sciences scientific Ali Darakhshandeh
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave, Isfahan
Isfahan Iran (Islamic Republic of) 8174797677 +98 31 3777 2640 alidarakhshandeh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients 18 to 75 years old hospitalized Patient with SpO2:85-89% on room air at admission (if correct with nasal O2 maximum 6 liter/min to SpO2>=90 ) Patients with SpO2: 90-93% and RR>=30 clinical compatible patients with positive RT-PCR test or consistent HRCT to covid19 pneumonia Sign the study participation form 18 years 75 years Both Known hypersensitivity to indomethacin or any components of NSAIDs History of asthma, urticarial, or other allergic type reaction after taking aspirin or NSAIDs GFR less than 60ml/minute/1.7m2 Patients with active gastrointestinal bleeding The need for intubation in the first 24 hours of hospitalization Patients with multi organ failure Patients with shock state at admission Pregnant woman Lactating woman Patients with active peptic ulcer Consumption of NSAID on admission U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group:ُُSlow release Indomethacin tablets, 75 mg daily for five days. Made by Aria Pharmaceutical Company Control group: A placebo similar to indomethacin tablets is given daily for five days Time to clinical recovery. Timepoint: Control clinical signs daily until discharge from the hospital. Method of measurement: Fever control with thermometer, oxygen saturation control with pulsoximetry. 14 days readmission after discharge. Timepoint: Up to 14 days after discharge. Method of measurement: All patients will be given a contact number to notify them if they are hospitalized again. All patients will be monitored by phone weekly for up to 4 weeks after the first day they are admitted. Time to intubation. Timepoint: Control of oxygen saturation, respiratory status every 6 hours during hospitalization. Method of measurement: If the patient needs intubation due to reduced oxygen saturation or increased respiration rate, the date of incubation will be recorded on a daily basis from the time of hospitalization. Survival 28 days after hospitalization. Timepoint: From the first day of hospitalization to 28 days after hospitalization. Method of measurement: A questionnaire is used to measure survival. At the time of hospitalization, this questionnaire is completed daily by one of the researchers. After discharge, the patient's condition will be monitored weekly for up to 4 weeks after the first day of hospitalization. Isfahan University of Medical Sciences Vice Chancellor for Research and Technology Approved 2020-04-14 National Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences No 566, 13 Alley, Saadat streat, Janbazan Blvd, Isfahan Isfahan Isfehan Iran (Islamic Republic of)