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IRCT20200731048257N1 IRCT 2020-11-08 Bagheiat-allah University of Medical Sciences Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study 2020-08-15 anticipated 224 Complete https://irct.ir/trial/50012 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To assign patients to two groups, the method of Permuted Balanced Block Randomization with the size of 4 and 6 random blocks will be used. Also, a unique code will be produced for each person and the medicines will be labeled using the mentioned codes and will be provided to the centers. Randomization will be done separately for each center and the effects of the centers will be adjusted in the analysis. The randomization sequence will be done in the Central Committee and separately for the centers. The randomization sequence will be generated and maintained by the epidemiologist colleague, Blinding description: Because the medications are labeled, the patient will not know exactly who is taking the original medication or the placebo, and the intervener who will give the medication to the patient will not be aware of this. Also, the evaluator of the results will be given only the patient code and the drug label code. 3 COVID-19. Intervention 1: Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Intervention 2: Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days. 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: Researchers can request data by emailing Dr.Reza mohtashami (reza_mohtashami1979@yahoo.com) How to obtain: Requested data will be sent by email after consideration and approval by the relevant authorities from Baghiattallah university. Comments:
public Milad Asghardoost rezaei
Mollasadra
Tehran Iran (Islamic Republic of) 1435915371 +98 31 5472 3386 milad.rezaei.9844@gmail.com Bagheiat-allah University of Medical Sciences scientific Mahdi Bagheri
Mollasadra
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8860 0067 mbagheri.pharm@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) informed consent to participate in the study Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR Strong clinical suspicion of covid 19 with positive findings in CT Scan Shortness of breath 18 years 75 years Both Patients with HIV Patients with cancer undergoing chemotherapy Patients receiving Immune Mediators Patients need hospitalization in the intensive care unit Patients with uncontrolled heart, kidney or liver failure Pregnant or lactating women Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems) U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days Dyspnea. Timepoint: The beginning of the study and the fifth day. Method of measurement: shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath. Length of hospitalization. Timepoint: At the end of hospitalization. Method of measurement: The length of time the patient is hospitalized after the diagnosis of COVID-19. Radiological Response. Timepoint: The first and fourteenth day of study. Method of measurement: CT scan. Mortality. Timepoint: At the end of hospitalization. Method of measurement: Duration of the day from hospitalization to discharge (acceptable recovery) or death based on Patient medical records. Allergy to medication. Timepoint: daily. Method of measurement: Questionnaire. Laboratory Response. Timepoint: at first day an fifth day. Method of measurement: Normal blood cell count and CRP count (normal laboratory range). O2 saturation without supplemental oxygen. Timepoint: Every six hours and at the end of the treatment and discharge period. Method of measurement: Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately. Adverse reactions to medication. Timepoint: daily. Method of measurement: physical examination. NCT04463420 مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا Bagheiat-allah University of Medical Sciences Approved 2020-05-16 The Ethics Committee of the Baqiyatallah University of Medical Sciences Mollasadra Tehran Tehran Iran (Islamic Republic of)