Trial NCT04446429
Publication Cadegiani FA, Cureus, 2021 (preprint)
Dates: 2020-09-15 to 2021-01-21
Funding: Mixed (Self-funded by the investigators. Proxalutamide was provided at no cost by Kintor Pharmecutical Ltd )
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Brazil Follow-up duration (days): 30 | |
| Inclusion criteria | SARS-CoV-2 status was laboratory-confirmed rtPCR testing;18 years or older;Absence of specific treatments for COVID-19 in the last 72 hours; Absence of contraindications to any of the treatments used in the trial;Oxygen saturation (SatO2) above 92% at the time of the first visit; No signs of complications related to COVID-19, e.g., secondary bacterial infections; and If female, not pregnant, or breastfeeding. |
| Exclusion criteria | Subject enrolled in a study to investigate a treatment for COVID-19; Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc.; Patients who are allergic to the investigational product or similar drugs (or any excipients); Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type; Subjects with known serious cardiovascular diseases, congenital long QT syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular ejection fraction (LVEF) < 50%, QTcF > 450 ms; Subjects with uncontrolled medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus); Known diagnosis of human immunodeficiency virus (HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory; Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal; Estimated glomerular filtration rate (eGFR) < 30 ml/min; Severe kidney disease requiring dialysis; Subject unlikely to return for day 15 site visit for reasons other then remission; Subject (or legally authorized representative) not willing or unable to provide informed consent. |
| Interventions | |
| Treatment
Proxalutamide 200 mg/day orally for 15 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 262 participants (n1=134 / n2= 128) | |
| Characteristics of participants N=262 Mean age : 44.6 262 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register COVID-19 hospitalization [ Time Frame: 30 days ] | |
| In the report Percentage of subjects hospitalized due to COVID-19 [Time Frame: 30 days] | |
| Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
High |
| General comment | In addition to the pre-print article, the Clinical Study Report, study registry (including posted results), and protocol were used in data extraction and risk of bias assessment. Outcome- and baseline data from the Clinical Study Report were prioritized since it included a larger sample size (n=262) compared to the pre-print article (n=214). The target sample size specified in the registry was achieved and there were no differences between the trial registration in the outcomes, intervention, or control treatments. |