Itraconazole vs Standard care (RCT)

Hospitalized patients

FOREST PLOTS -2021-06-18

Studies description

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
  • 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

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=*
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
avalaible

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.