Trial IRCT20190727044343N1
Publication Davoodi L, Int J Clin Pract, 2020 (published paper)
Dates: 2020-03-15 to 2020-03-27
Funding: Public/non profit (Mazandaran University of Medical Science, Sari, Iran)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteria1. chest CT finding compatible with COVID-19 infection along with other symptoms of coronavirus infection. Bilateral and peripheral ground-glass and consolidative pulmonary opacities were the hallmarks of CT findings. 2. any symptoms of respiratory tract involvement including cough, dyspnea or tachypnea along with a history of contact with a known case of COVID-19 3. creatinine clearance greater than 60 ml/min.
Exclusion criteria1. Suspicious patients for COVID-19 pneumonia who had severe underlying diseases such as cardiovascular, lung and kidney diseases, 2. patients with severe pneumonia needing hospitalization, 3. patient who were unable to take oral medications and 4. concurrent use of azathioprine, didanosine, mercaptopurine or pegloticase (due to drug interaction with FBX).
Interventions
Treatment
Febuxostat (80 mg)
Duration : 5 days
Control
Hydroxychloroquine (200 mg)
Duration : 5 days
Participants
Randomized
60 participants (n1=30 / n2= 30)
Characteristics of participants
N=60
Mean age : 57.7
32 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0
Primary outcome
In the register
No
In the report
rate of hospitalization.
Documents
avalaible

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 In addition to the published report, the trial registry was used in data extraction and assessment of risk of bias. The trial achieved is registered sample size, but was affected by 10% attrition. There were differences between the trial registry and the published report in primary outcome and inclusion/exclusion criteria. All participants were outpatients. Doses and schedules of the study drugs were not included in the trial registry. The registry specified the trial as 'double blind' however the report describes the study as 'open-label' study with blinded outcome assessors.