]>
IRCT20200616047792N1 IRCT 2020-08-03 Ahvaz University of Medical Sciences A study of therapeutic effect of blood ozone therapy of severe Covid-19 patients Study of intra-venous ozonated auto-hemotherapy on severe cases of COVID-19: A randomized clinical trial 2020-08-18 anticipated 60 Complete https://irct.ir/trial/48978 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization using https://www.sealedenvelope.com/. N/A Covid-19. Intervention 1: Control group: This group will receive the Iranian nationally implemented treatment protocol of Covid-19, which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy. Intervention 2: Intervention Group: In the intervention group in addition to the Iranian nationally implemented protocol of Covid-19 treatment (which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy) will receive a thrice weekly -up to two weeks- of ozonization of 200 cc of patient blood drawn and mixed with three 40ml draws (equivalent to 120ml) of 30μg/mL of ozone gas over 5 min which is then transfused back into patient's blood stream over15 minutes. 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: The related data will be provided to all interested 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: behnamshei@gmail.com How to obtain: Contact via email: behnamshei@gmail.com Comments:
public Behnam Sheibani
Felestin Blvd
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3392 5312 behnamshei@gmail.com Ahvaz University of Medical Sciences scientific Shokrollah Salmanzadeh Ramhormozi
Felestin Blvd, Ahvaz
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 75 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 virus identified, Clinically-epidemiologically diagnosed COVID-19 Treatment - Other Treatment - Other Control group: This group will receive the Iranian nationally implemented treatment protocol of Covid-19, which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy. Intervention Group: In the intervention group in addition to the Iranian nationally implemented protocol of Covid-19 treatment (which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy) will receive a thrice weekly -up to two weeks- of ozonization of 200 cc of patient blood drawn and mixed with three 40ml draws (equivalent to 120ml) of 30μg/mL of ozone gas over 5 min which is then transfused back into patient's blood stream over15 minutes. Length of hospital stay. Timepoint: Daily since the time of 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. Need for mechanical ventilation. Timepoint: Daily since hospitalization. Method of measurement: Patient's file. Duration of need for mechanical ventilation. Timepoint: Daily since mechanical ventilation. Method of measurement: Patient's file. Case fatality rate. Timepoint: Daily since intervention. Method of measurement: Patient's file. C-reactive protein. Timepoint: Thrice weekly. Method of measurement: Biochemistry method. White blood cell count. Timepoint: Thrice weekly. Method of measurement: Cell counter. Change in lung CT scan appearance. Timepoint: End of week one and week two. Method of measurement: Chest spiral CT scan. ESR. Timepoint: Thrice weekly. Method of measurement: Biochemistry method. Ahvaz University of Medical Sciences Approved 2020-06-06 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)