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 ( / ) Definition of Standard care: All patients were treated according to "Iranian Guideline of Hospitalized COVID-19 Patients Management (version 5)". This comprised a heparin prophylaxis in combination with supplemental oxygen and intravenous or oral fluid therapy. | |
| Participants | |
| Randomized 80 participants (n1=40 / n2= 40) | |
| Characteristics of participants N=80 Mean age : NR 80 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| 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 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 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. |