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IRCT20210519051348N1 IRCT 2021-10-31 Shiraz University of Medical Sciences Evaluation of safety and efficacy of Desferal + Zinc nasal spray Evaluation of safety and efficacy of Desferal + Zinc nasal spray to improve clinical and pulmonary symptoms in patients with COVID-19 2021-10-23 anticipated 60 Complete https://irct.ir/trial/58922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be performed (each block includes 6 patients). Dedicated sequences and hidden codes using www.sealedenvelope.com are produced. The closed envelope method will be used to hide the allocation sequence, Blinding description: In this study, the patients participating in the study as well as the clinician evaluating the patient and the person analyzing the data were kept blind and the researcher was aware of the drug and placebo recipients. To perform blinding during randomization using the site www.sealedenvelope.com, by activating the generate uniqe ramdimization code option, each patient will be given a special code that will be written on the medicine containers and all the containers will be exactly the same. And these codes remain confidential with the researcher until the end of the study. 2-3 covid19. Intervention 1: Intervention group 1: Nasal spray Desferal + Zinc,chemical ingredients: desferrioxamine (500mg) plus Zinc acetate (200 mg) in a volume of 10 cc.Dosing: 2 Puffs in the nose every eight hours for a week. Intervention 2: Intervention group2: Nasal spray Zinc,chemical ingredients: Zinc acetate (200 mg) in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week. Intervention 3: Control group: Distilled water spray in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week. Yes - There is a plan to make this available What will be shared: Information on the main outcomes studied can be shared. When: The data will be available after the publication of all the obtained results. To whom: Only for researchers working in academic and scientific institutions Conditions: The study or proposal protocol must be approved by the Ethics Committee of the institution or university. The rights of authors and their sponsors must be protected. Where to obtain: Shiraz School of Pharmacy to the email address pharmacyfaculty@sums.ac.ir and contact number 00987132424128 Dr. Laleh Mahmoudi to the email address mahmoudi_l@sums.ac.ir and the contact number 00989126135992 How to obtain: Requests should be addressed to the Technology and Research Vice-chancellery of Shiraz University of Medical Sciences and the project executor should informed.After submitting the application, a maximum of one week will be answered . Comments:
public Navid Esmaeilzadeh Shahri
Ferdowsi Ave.
Shiraz Iran (Islamic Republic of) ۷۱۳۵۷۶۵۷۴۸ +98 71 3231 5156 esmaeilzadeh_n@sums.ac.ir Shiraz University of Medical Sciences scientific laleh mahmoudi
Akbarabad Ave.
Shiraz Iran (Islamic Republic of) ۷۱۴۶۸۶۴۶۸۵ +98 71 3242 4127 mahmoudi_l@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Informed and written consent of patient with Coronavirus Confirmation disease by clinical and laboratory signs Serum creatinine less than two Milligram per Deciliter Absence of heart problems( myocarditis- heart failure ) Hemoglobin above 8 Gram per Deciliter Patients admitted to the ward with moderate symptoms 18 to 65 years 18 years 65 years Both Ferritin lower than 100 milligram per deciliter Diabetes History of blood coagulation problems Pregnancy and Breastfeeding History of neurologic problems History of vision and hearing problems concomitant use of vitamin C Intubated patient History of Desferal or Zinc allergy U07.1 COVID19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Nasal spray Desferal + Zinc,chemical ingredients: desferrioxamine (500mg) plus Zinc acetate (200 mg) in a volume of 10 cc.Dosing: 2 Puffs in the nose every eight hours for a week Intervention group2: Nasal spray Zinc,chemical ingredients: Zinc acetate (200 mg) in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week Control group: Distilled water spray in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week Interleukin6. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT. Body temperature. Timepoint: Before the intervention and every day during the study. Method of measurement: Thermometer. Oxygen saturation. Timepoint: Before the intervention and every day during the study. Method of measurement: Pulse oximeter. Cough. Timepoint: Before the intervention and every day during the study. Method of measurement: questionnaire. Duration of hospitalization. Timepoint: Admission period until hospital discharge. Method of measurement: Patient file. Incidence of serious adverse events. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire. Shiraz University of Medical Sciences Approved 2021-09-12 Ethics Committee of Shiraz University of Medical Sciences Karimkhanzand Ave. Shiraz Fars Iran (Islamic Republic of)