]>
IRCT20200730048253N1 IRCT 2020-08-08 Ahvaz University of Medical Sciences Evaluating the effectiveness of intravenous ozonized saline in COVID-19 disease Evaluating the effectiveness of intravenous ozonized saline in treatment of severe COVID-19 disease: A randomized Control trial 2020-08-22 anticipated 60 Complete https://irct.ir/trial/50031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization with blocks with size of 6 and by the means of https://www.sealedenvelope.com/, Blinding description: Except of investigator, all of participants in the study wont be aware of the group treatment of the patient and they wont know the patient are in ozonated normal saline or normal saline alone. 3 COVID-19. Intervention 1: Intervention group: The intervention group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) in addition to a thrice weekly ozonated normal saline Thus, 400 ml of normal saline is ozonated by 40 micrograms per kilogram of body weight of the patient by Medozon device within ten minutes (ozone concentration in normal saline with this method is 5mic / ml) and within 15 minutes It is injected into the patient for 30 minutes (80 to 120 drops per minute). This is done daily every morning for a week. Intervention 2: Control group: The control group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) and normal saline that is not ozonated. Taking normal saline is daily for a week. Yes - There is a plan to make this available What will be shared: All related data will be provided upon completion of the study after disidentified IPD When: The related data will be indefinitely provided upon completion of the study. To whom: Relevant information will be provided to all interested parties for humanitarian study and research purposes upon completion of the study. Conditions: On the condition that if any of the study methods (including study design and implementation method, measurement methods, etc.) are used the copyright law be observed and our study be cited. Where to obtain: This will be provided upon completion of the study. Contact: e24267s@gmail.com How to obtain: Contact via email: e24267s@gmail.com Comments:
public najme dareini
felestin blvd
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3392 5312 e24267s@gmail.com Ahvaz University of Medical Sciences scientific Shokrollah Salmanzadeh Ramhormozi
Felestin bolvd
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3392 5312 salmanidmd@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Severe cases of Covid-19 with chest CT changes in the form of peripheral uni- or bilateral ground glass opacity(s) in combination with any of the below: RR greater than 24, O2 Sat less than 93%, BP less than 90/60, decreased level of consciousness. 18 years 70 years Both G6PD Deficiency Coagulopathies and thrombocytopenia Hx of seizure Hypothyroidism Pancreatitis Hemophilias Acute alcohol poisoning Pregnancy and breast feeding Allergy to ozone and ozonated products U07.1 COVID-19 Treatment - Other Treatment - Other Intervention group: The intervention group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) in addition to a thrice weekly ozonated normal saline Thus, 400 ml of normal saline is ozonated by 40 micrograms per kilogram of body weight of the patient by Medozon device within ten minutes (ozone concentration in normal saline with this method is 5mic / ml) and within 15 minutes It is injected into the patient for 30 minutes (80 to 120 drops per minute). This is done daily every morning for a week Control group: The control group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) and normal saline that is not ozonated. Taking normal saline is daily for a week. Duration of hospitalization. Timepoint: Daily Since hospitalization. Method of measurement: patient's file. Need for ICU. Timepoint: daily since hospitalization. Method of measurement: patient's file. Duration of ICU stay. Timepoint: Daily since ICU stay. Method of measurement: Patient's file. Ahvaz University of Medical Sciences Approved 2020-07-26 Ethics Committee of Ahwaz Jundishapur University of Medical Sciences golestan st, َAhvaz Khouzestan Iran (Islamic Republic of)