Trial EudraCT 2020-001243-1
Publication DAWn-ITZ - Liesenborghs L, SSRN (2020) (preprint)
Dates: 2020-03-01 to 2020-04-30
Funding: Public/non profit (Covid-19-Fund KU Leuven, Research Foundation - Flanders (FWO), Horizon 2020, Bill and Melinda Gates Foundation)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Belgium Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Itraconazole 200 mg orally 3 times a day for the first 3 days, followed by 200 mg twice a day. Itraconazole was continued for 10-14 days. |
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Control
Standard care | |
Participants | |
Randomized NR Analyzed 65 participants Itraconazole=32 Standard care=33 | |
Characteristics of participants N= 65 Mean age : NR 41 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=* Number of vaccinated participants: NR | |
Primary outcome | |
In the register Clinical status of subject at day 15 (on a 7-point ordinal scale) | |
In the report Cumulative clinical status on day 15 (the sum of daily clinical status scores on the 7-point WHO ordinal scale) | |
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 |
Some concerns |
General comment | The pre-print article and trial registry were used in data extraction and assessment of risk of bias. Supplementary appendix and figures that were referred to in the pre-print were not accessible at the time of data extraction, nor was a protocol. The study was terminated early due to futility. As a result, the target sample size specified in the registry was not achieved. There were no other substantive differences in population, procedures, interventions or outcomes between the pre-print article and the trial registry. |