Trial EudraCT 2020-001243-1
Publication 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 | Hospitalized patients aged 18 years or older with COVID-19; confirmed by PCR or a typical chest CT-scan; displayed at least one of the following features: radiographic infiltrates, Sp02 ≤ 94% on room air, or requiring supplemental oxygen. |
Exclusion criteria | Elevated liver tests (ALT/AST > 5 times the upper limit of normal); pregnancy or breast feeding; heart failure with severely reduced ejection fraction (≤ 30%); concomitant treatment with lopinavir/ritonavir or potent CYP450 inducers |
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. |
|
Control
Standard care Definition of Standard care: Standard of care was defined by the Belgian COVID-19 guidelines, which at the time of recruitment included supportive treatment, broad spectrum antibiotics (ceftriaxone 2g/day) and hydroxychloroquine (400 mg twice daily loading dose, followed by 200 mg twice daily for five days). | |
Participants | |
Randomized * participants (n1=* / n2= *) | |
Characteristics of participants N=* Mean age : NR 41 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=* | |
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 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 |
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. |