Trial NCT04366089
Publication PROBIOZOVID - 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
Oxygen-Ozone : 30 mcg/ml in 250 ml peripheral venous blood twice a day for 7 days. Probiotic: 1 sachet twice a day for 7 days
Control
Standard care

Participants
Randomized
participants :
Oxygen-Ozone+Probiotic=14
Standard care=14
Characteristics of participants
N= 28
Mean age : NR
16 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
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
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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.