Trial IRCT20200505047318N1
Publication Zarehoseinzade E , Med J Islam Repub Ir (2021) (published paper)
Dates: 2020-05-01 to 2020-06-30
Funding: Public/non profit (Qazvin University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): *
Inclusion criteria
  • Hospitalized
  • informed consent
  • clinical symptoms suggestive of COVID-19 pneumonia, including cough (with or without sputum), fever, pleuritic chest pain, or dyspnea
  • CT scan findings compatible with COVID-19 or positive RT-PCR of COVID-19
  • male patients aged 50 years or older
  • moderate and severe disease
Exclusion criteria
  • Presence of severe immunosuppression (e.g., use of immunosuppressants)
  • malignancy
  • any likely infection other than COVID-19 pneumonia
  • indications that the patient was unable and/or unlikely to comprehend and/or follow the protocol
  • liver function abnormalities
  • positive drug history of finasteride medication or hypersensitivity to any component of this medication
Interventions
Treatment
Finasteride
5 mg orally once daily for 7 days
Control
Standard care

Participants
Randomized
participants :
Finasteride=40
Standard care=40
Characteristics of participants
N= 80
Mean age : NR
80 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
o2 saturation of blood (initial/fifth day of hospitalization)
In the report
Death/alive status and length of hospital stay
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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 retrospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The study achieved the target sample size specified in the trial registry. The control group was described as placebo in the registry but usual care in the report. The primary outcome in the report (mortality and length of hospital stay) did not reflect that in the registry (O2 saturation of blood). Other outcomes reported in the article (vital signs and laboratory results, lengths of hospital stay, ICU stay and intubation, Glasgow Coma Scale, discharge, mortality) were not included in the registry. Participant follow-up time was unclear.