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IRCT20200318046812N2 IRCT 2020-04-08 Bagheiat-allah University of Medical Sciences evaluation of Safety and efficacy of anti inflammatory regimens in COVID-19 Safety and efficacy of “Hydroxychloroquine + Azithromycin + Naproxen + Prednisolone” and “Hydroxychloroquine + Azithromycin + Naproxen” regimens in comparison with “Hydroxychloroquine + kaletra” on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study 2020-04-10 anticipated 906 Complete https://irct.ir/trial/46968 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use block randomization methods using variable block size of four and six stratified by center. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team. 3 COVID-19. Intervention 1: Intervention group: Intervention group: Group 1: Patients in this group will first receive hydroxychloroquine as two 200 mg tablets with a total of 400 mg of stat; then the following regimen will be continued for 5 days - azithromycin two 250 mg tablets on the first day. And then 250 mg daily for 5 days - 5 mg prednisolone tablets in the amount of 5 tablets (25 mg) daily for 5 days - 250 mg naproxen tablets twice a day for 5 days. Also, patients in this group to prevent complications. Digestive patients will receive 40 mg of pentoprazole tablets or capsules daily during treatment. According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary. The patient will be discharged from the protocol. In this case, all the patient's information will be collected until the end of the study. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Prednisolone in this group will continue to be cleared and gradually reduced to 5 mg each week to be discontinued. The weekly dose will be as follows: -First week after clearance: 20 mg per day -Second week after clearance: 15 mg per day- Third week after clearance: 10 mg per day -Fourth week after clearance 5 Mg per day and finally discontinued. Intervention 2: Intervention group: Patients in this group will first receive hydroxychloroquine in the form of two 200 mg tablets with a total of 400 mg of stat; then the following diet will be continued for 5 days.- Azithromycin two 250 mg tablets on the first day and then 250 mg daily for 5 days- Naproxen tablets 250 mg twice daily for 5 daysIn addition, patients in this group will receive 40 mg tablets or pentoprazole capsules daily to prevent gastrointestinal side effects during treatment.According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary.In this group, starting antiviral or steroid therapy before the need for treatment in the intensive care unit will cause the patient to leave the protocol. In this case, all patient information will continue to be collected until the end of the study.If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Intervention 3: Control group: Patients in this group first receive two 200 mg hydroxychloroquine stats and then receive the following diet for 7 to 10 days:- kaltra (Lupinavir / Ritonavir) twice a day and two tablets of 200/50 mg each time for 7 days.Acetaminophen and oxycodone will be used if you need painkillers and antipyretics.According to the attending physician, this treatment protocol can be continued for 14 days, depending on the clinical symptoms, if necessary.In this group, the use of steroidal and non-steroidal anti-inflammatory drugs is not allowed until the need for treatment in the intensive care unit. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Yes - There is a plan to make this available What will be shared: Deidentified IPD related to outcome will be shared. When: The access period will begin 6 months after publication of the paper To whom: The data will be available only for academic researchers. Conditions: Only meta-analysis in collaboration with the current study research team will be permitted. Where to obtain: From where data/document is obtainable Researchers can request data by emailing Dr. Mustafa Qanei (mghaneister@gmail.com) or Dr.Ali Qazvini(qazvinia@gmail.com) How to obtain: Requested data will be sent by email after consideration and approval by the relevant authorities from Baghiattallah university. Comments:
public Seyed Hassan Saadat
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8860 0067 saadat350@gmail.com Bagheiat-allah University of Medical Sciences scientific Ali Qazvini
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8860 0067 qazvinia@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RTPCR test for COVID-19 Requiring hospitalization Patient's age between 16 and 100 years Signed informed consent form 16 years 100 years Both Past history of hospitalization or treatment in hospital for COVID-19 disease Receiving other antiviral medications such as (Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir) Uncontrolled diabetes Astma Chemotherapy in the past month Taking immunosuppressive drugs Chronic liver or renal failure Taking daily systemic corticosteroids HIV GI bleeding Pregnancy or Lactation Uncontrolled bacterial infection U07.1 COVI COVID-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Group 1: Patients in this group will first receive hydroxychloroquine as two 200 mg tablets with a total of 400 mg of stat; then the following regimen will be continued for 5 days - azithromycin two 250 mg tablets on the first day. And then 250 mg daily for 5 days - 5 mg prednisolone tablets in the amount of 5 tablets (25 mg) daily for 5 days - 250 mg naproxen tablets twice a day for 5 days. Also, patients in this group to prevent complications. Digestive patients will receive 40 mg of pentoprazole tablets or capsules daily during treatment. According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary. The patient will be discharged from the protocol. In this case, all the patient's information will be collected until the end of the study. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Prednisolone in this group will continue to be cleared and gradually reduced to 5 mg each week to be discontinued. The weekly dose will be as follows: -First week after clearance: 20 mg per day -Second week after clearance: 15 mg per day- Third week after clearance: 10 mg per day -Fourth week after clearance 5 Mg per day and finally discontinued Intervention group: Patients in this group will first receive hydroxychloroquine in the form of two 200 mg tablets with a total of 400 mg of stat; then the following diet will be continued for 5 days.- Azithromycin two 250 mg tablets on the first day and then 250 mg daily for 5 days- Naproxen tablets 250 mg twice daily for 5 daysIn addition, patients in this group will receive 40 mg tablets or pentoprazole capsules daily to prevent gastrointestinal side effects during treatment.According to the attending physician, this treatment protocol can be continued for 10 days, depending on the clinical symptoms, if necessary.In this group, starting antiviral or steroid therapy before the need for treatment in the intensive care unit will cause the patient to leave the protocol. In this case, all patient information will continue to be collected until the end of the study.If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Control group: Patients in this group first receive two 200 mg hydroxychloroquine stats and then receive the following diet for 7 to 10 days:- kaltra (Lupinavir / Ritonavir) twice a day and two tablets of 200/50 mg each time for 7 days.Acetaminophen and oxycodone will be used if you need painkillers and antipyretics.According to the attending physician, this treatment protocol can be continued for 14 days, depending on the clinical symptoms, if necessary.In this group, the use of steroidal and non-steroidal anti-inflammatory drugs is not allowed until the need for treatment in the intensive care unit. If treatment is needed in the intensive care unit, all treatment methods will be used according to the patient's clinical needs and the decision of the treating physician. Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records. In-hopital mortality. Timepoint: Once. Method of measurement: Patient medical records. Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records. Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one. Method of measurement: Patient CT scan. Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits. Fever. Timepoint: Daily. Method of measurement: Patient medical records. Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records. Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation. Oxygen therapy maximum flow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records. Discharge without Intensive care need. Timepoint: Once. Method of measurement: Patient medical records. Pulmonary function. Timepoint: 6 weeks after discharge. Method of measurement: Spirometry and a six-minute walking test are performed. Pulmonary function status is divided into two groups, normal and abnormal. Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms. Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms. Iran University of Medical Sciences Bagheiat-allah University of Medical Sciences Iran University of Medical Sciences Approved 2020-03-26 Baqiyatallah university of medical sciences Tehran, Vanak Square, Mulla Sadra Street Tehran Tehran Iran (Islamic Republic of)