Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

Table 2 Schedule of patient assessments

Time Point	Screening	Treatment Period		Safety Follow-up
Time Point	Screening	Baseline (Day 1)	Day 2-Day 7 (up to Day 14)	Day 15 ± 2	Day 22 ± 2		Day 30 ± 3	Day 60 ± 3
Informed consent	●
Verify eligibility criteria	●
Demographics	●	●
Medical History	●	●
Targeted physical exam	●	●
Review SARS-CoV-2 results	●	●
Review X-ray or CT if applicable	●	●
Vaccination status	●	●
Vital signs including SpO₂	●	●	Once a day till discharge	●			●^a
Targeted Physical Examination		●	●	●
Clinical data collection		●	●	●	●^a
AEs evaluation		●	Once a day till discharge	●	●		●	●
Concomitant medication review		●	Once a day till discharge	●	●		●
X-ray or CT			●^a	●^a
12-ECG	The decision is made by professional investigators
Hematology, urine routine, and coagulation action test	●	●	Day 3, 5, 8 (all ± 1 day)	●		●
Pregnancy test for females of childbearing potential	●					●
Nasopharyngeal swab		●	Day 3, 5, 8 (all ± 1 day)	●		●^a

AEs adverse events, CT computed tomography, ECG electrocardiography, PI principal investigator, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
^a optional; ● mandatory

ISSN: 2050-6511