Trial NCT04366089
Publication Araimo F , J Med Virol, 2020 (published paper)
Dates: 2020-04-01 to 2020-05-31
Funding: No specific funding (No funding )
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Italy Follow-up duration (days): 30 | |
| Inclusion criteria | 1) Age > 18 years,
2) Nasopharyngeal swab positive for COVID-19, 3) COVID-19 stages III, 4) Hospitalization in the infectious disease wards. [Italian staging: Stage III = serious pneumonia - severe COVID-19] |
| Exclusion criteria | 1) COVID-19 stages IV - V – VI,
2) Hospitalization in ICUs, 3) Pregnancy, 4) Glucose-6- phosphate dehydrogenase (G6PD) deficiency, 5) Patients who deny consent to the proposed treatment, 6) Inability to provide informed consent, 7) Contraindications to performing oxygen-ozone therapy (hyperhomocysteinemia, favism or thyroiditis, coagulopathies, neurodegenerative diseases). |
| Interventions | |
| Treatment
Oxygen-Ozone+Probiotic (7.5x10^3 mcg/1 Sachet) Co-Intervention: Standard care Duration : 7 days |
|
| Control
Standard care Definition of Standard care: Treatment options were based on the interim guidelines of the Italian Society of Infectious and Tropical Diseases. Antiviral treatments with Lopinavir/Ritonavir 200/50 mg (2 tablets bid) or azithromycin 500mg/daily plus hydroxychloroquine 200mg/bid were available. Tocilizumab 8 mg/kg iv (up to a maximum of 800mg per dose) twice with an interval of 12 hours was administered in case of high serum levels of Interleukin (IL)-6 or worsening of respiratory function. An empirical broad- spectrum antibiotic treatment was considered when appropriate. | |
| Participants | |
| Randomized 28 participants (n1=14 / n2= 14) | |
| Characteristics of participants N=28 Mean age : 61.7 16 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Delta in the number of patients requiring orotracheal intubation despite treatment [ Time Frame: 21 days ] | |
| In the report Delta in the number of patients requiring orotracheal intubation despite treatment. | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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 |
High |
| General comment | In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias.Neither the protocol nor the statistical analysis plan were available. There were no substantive differences between the retrospective registration and the published article in terms of treatments and outcomes. Inclusion criteria in the registry differ form the published article. The report is a preliminary analysis of an ongoing trial, so only a portion of the intended sample size was included. |