Process | Screening/baseline/randomization | Treatment phase | Follow-up phase | ||
---|---|---|---|---|---|
B/L/D0 | D1–D10 | D14 ±1 | D21 ±3 | D28 ±3 | |
Inclusion/exclusion criteria | X | ||||
Written informed consent | X | ||||
Demographics | X | ||||
Assessment of concomitant chronic diseases | X | ||||
Efficacy/safety assessment | |||||
ECG | X | X | |||
Chest imaging | X | X (only on D10) | X | ||
Vital signs (body temperature, heart rate, blood pressure, breathing rate, oxygen saturation, etc.) | X | X | X | X | X |
Clinical symptoms assessment (fever, cough, diarrhea, dyspnea) | X | X | X | X | X |
Primary endpoint assessment | X | X | X | X | X |
Adverse events | X | X | X | X | X |
Laboratory test | |||||
Diagnosis (clinical diagnosis, antibody diagnosis, or pathogen diagnosis) | X | ||||
Whole blood count (sampling time) | X | X (only on D3, D7, and D10) | |||
Coagulation routine (sampling time) | X | X (only on D3, D7, and D10) | |||
Kidney and liver function tests (sampling time) | X | X (only on D3, D7, and D10) | |||
Arterial blood gas analysis | X | ||||
Pregnancy test (urine/blood, for women of childbearing age only) | X | ||||
Nasopharyngeal/ oropharyngeal swab | X | X | X | X | X |
Lower respiratory tract specimen (sputum/tracheal aspirate/bronchial alveolar lavage fluid) if available | X | X | X | X | X |
Feces/anal swabs | X | X | X | X | X |
Pharmacokinetic sampling (approximately 4 ml whole blood) | X (only on D1, D3, D7 [as needed], and D10) | ||||
Interventions | |||||
Remdesivir/placebo | X | ||||
Concomitant medications (record only) | X | X | X | X | X |