Trial NCT04794803; EudraCT 2020-001645-40
Publication Landoni G, Infect Dis Ther (2022) (published paper)
Dates: 2020-05-05 to 2020-10-30
Funding: Private (Dompe´ Farmaceutici SpA, Milan, Italy. Dompe´ Farmaceutici SpA participated in the design and conduct of the study; management, analysis, and interpretation of the data; preparation and review of the manuscript; and provided funding for the journal’s Rapid Service Fee.)
Conflict of interest: Yes
Multicenter / Brazil, Italy |
Follow-up duration (days): 28
1200 mg orally three times a day for 7-21 days.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=25 / Severe: n=30 Critical: n=0
Number of vaccinated participants: 0
|In the register|
Percentage of Participants With Composite Endpoint of Clinical Events [ Time Frame: Up to Day 1 ] Composite event is defined as the onset of at least one of the following events: supplemental oxygen requirement based on a worsening of PaO2/FiO2 ratio, invasive mechanical ventilation use, admission to Intensive Care Unit (ICU), use of a rescue medication for any reason.
|In the report|
Time-to-event analysis of the composite endpoint of clinical events. The composite endpoint was defined as patients requiring at least one of the following at any time during treatment or follow-up: supplemental oxygen, based on deterioration of the PaO2/FiO2 ratio by at least one-third (− 33.3%) from baseline PaO2/FiO2, mechanical ventilation use, admission to ICU, and/or use of a rescue medication for any reason.
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published article, the trial registries, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The composite primary outcome was a time-to-event outcome in the article but a proportion in the registry. The primary and secondary outcomes were altered in the registry during the course of the study, but overall reflect those in the first version of the registration. The trial (n = 56) achieved the target sample size stated in the protocol and report (n = 48). The study had a high rate of non-completion.|