Trial NCT04729491
Publication Cadegiani F, Cureus, 2021 (published paper)

Funding: No specific funding (No financial support was received from any organization for the submitted work)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / Brazil
Follow-up duration (days): 60
Inclusion criteriaPositive RT-PCR-SARS-CoV-2 test; male; older than 18 years of age; COVID-19 infection lasting less than seven days; absence of specific treatments for COVID-19 for periods longer than 72 hours; no prior adverse reaction to dutasteride; oxygen saturation (SaO2) above 92% at the time of enrollment; no signs of complications related to COVID-19 and secondary bacterial infections at the time of screening.
Exclusion criteriaSubject enrolled in a study to investigate a treatment for COVID-19; Require oxygen use, hospitalization or mechanical ventilation; Tachycardia (HR > 150 bpm); hypotension (BP < 90/60 mmHg); Patients who are allergic to the investigational product or similar drugs (or any excipients); Subjects with QTcF > 450 ms; Subjects with uncontrolled medical conditions that could compromise participation in the study - uncontrolled hypertension (BP > 220/120 mmHg), uncontrolled hypothyroidism (TSH > 10 iU/L), uncontrolled diabetes mellitus (HbA1c > 12%); Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal; Estimated glomerular filtration rate (eGFR) < 30 ml/min or requiring dialysis; Subject (or legally authorized representative) not willing or unable to provide informed consent; Not willing to provide informed consent.
Interventions
Treatment
Dutasteride
0.5 mg orally once daily for 30 days or until full COVID-19 remission
Control
Placebo
Participants
Randomized
130 participants (n1=64 / n2= 66)
Characteristics of participants
N=130
Mean age : 41.9
87 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis) [Time Frame: Day 7]:
Treatment efficacy of dutasteride relative to placebo arm as assessed by viral load measured by positivity rate (% of positive, detected rtSARS-CoV-2)
In the report
Remission times for fatigue and loss of taste or smell (ageusia or anosmia), time to overall COVID-19 remission including and not including anosmia and ageusia.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

No
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 article, the study registry and 2 preprints (Cadegiani 2020, in medRxiv and Research Square) were used in data extraction and risk of bias assessment. The trial was registered retrospectively after the study had been completed. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. Some outcomes and timepoints listed in the registry were not reported in the publication, such as clinical improvement based on the WHO progression scale. The study achieved the target sample size. There were 31-35% missing data in each group. The pre-print article reports different numbers randomized (138 vs 130) and analyzed for both arms (44 vs 43) of the study to the published article, and different outcomes and timepoints. The publication reports, "no financial support was received from any organization" and the preprint states, "The funding of present study was fully supported by Corpometria Institute (Brasilia, DF, Brazil) and Applied Biology Inc (Irvine, CA, USA)".