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 |
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Exclusion criteria |
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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 |
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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. |