Status:
COMPLETED
EAT-DUTA AndroCoV Trial
Lead Sponsor:
Corpometria Institute
Conditions:
Covid19
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%). Among child...
Eligibility Criteria
Inclusion
- Male
- ≥18 years old
- Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
- Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3
- Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
- Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study
Exclusion
- Subject enrolled in a study to investigate a treatment for COVID-19
- Require oxygen use, hospitalization or mechanical ventilation
- Tachycardia (HR \> 150 bpm) or 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2020
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04729491
Start Date
June 30 2020
End Date
October 7 2020
Last Update
January 28 2021
Active Locations (1)
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1
Corpometria Institute
Brasília, Federal District, Brazil, 70390-150