Trial NCT04388514
Publication Sozio E, Int Immunopharmacol, 2021 (published paper)
Dates: 2020-04-01 to 2020-10-21
Funding: No specific funding (No financial support was received.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Multicenter / Italy Follow-up duration (days): 10 | |
| Inclusion criteria | Patients > 18 years of age ; positive SARS COV 2 RT-PCR results ; signs and symptoms of pneumonia confirmed by chest imaging ; requiring hospitalization ; informed consent provided. |
| Exclusion criteria | Pregnancy; glucose 6 phosphate dehydrogenase deficiency; concomitant life-threatening disease. |
| Interventions | |
| Treatment
Oxygen-Ozone 200 mL (96% Oxygen & 4% Ozone) IV daily for 3 consecutive days. |
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| Control
Standard care ( / ) Definition of Standard care: Standard of Care (SoC) therapy. Best available therapy included the following treatment options: antiretroviral therapy (Lopinavir/Ritonavir 200/50 mg 2 tablets every 12 h or Darunavir/Cobicistat 800/150 mg 1 tablet per day) and HCQ 400 mg every 12 h on the first day, followed by 200 mg every 12 h for the following 4 days. Other therapy used for the treatment of COVID-19 pneumonia were administered by caring physicians accordingly. Of notice, steroid therapy was only supported by WHO and endorsed by AIFA in June 2020, hence, many patients were subsequently also treated with steroids (Dexamethasone 6 mg once daily for up to 10 days) even if this therapy was not initially included in the planned protocol drafting. | |
| Participants | |
| Randomized 96 participants (n1=48 / n2= 48) | |
| Characteristics of participants N=96 Mean age : 63.9 55 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Time of respiratory improvement and earlier weaning from oxygen support [Time Frame: 3 days and 10 days] | |
| In the report Negative SIMEU delta classes (negative values implying clinical improvement) assessed on the day following day 3 and 10; admission to Intensive Care Unit; death. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the retrospective trial registry was used in data extraction and assessment of risk of bias. The trial was not registered prospectively; the study started on 1 April 2020 and the registration was on 14 May 2020, with no subsequent changes made; in the early stages of the study infections were reduced by lock-down measures so that “enrolment was mainly carried out throughout the second Italian wave of COVID-19 pandemics (September and October 2020)”. The study protocol provided in the registry was not adequate for use. The outcomes extracted were not included in the registry. There were no other major differences in population, procedures, interventions or outcomes between the registry and the article. The trial achieved its target sample size. |