Day ± window | Screen | Baseline | Daily until discharge | 6 ± 2 | 15 ± 2 | 29 ± 3 | 5–7 weeks post-discharge | Day 90 |
---|---|---|---|---|---|---|---|---|
− 3 to 0 | 0 | |||||||
Assessments/procedures | ||||||||
Eligibility | ||||||||
Informed consent | X | |||||||
Demographics and medical history | X | |||||||
Review COVID-19 criteria | X | |||||||
Inclusion and exclusion criteria | X | |||||||
Studyintervention | ||||||||
Randomization | X | |||||||
Administration of study drug | X | Daily for 5 days | ||||||
Studyprocedures | ||||||||
Vital signs including SpO2 | X | X | Daily until discharge | |||||
Clinical data collection | X | X | Daily until discharge | X | ||||
Targeted medication review | X | X | Daily until discharge | X | ||||
Adverse event evaluation | X | X | Daily until discharge | X | ||||
ECGb | X | X | QT monitoring scheme | |||||
Evaluation by telephone | X | X | If outpatient visit is not feasible | x | ||||
Evaluation on outpatient clinic | Xa | |||||||
Spirometry + reversibility | Xa | |||||||
Lung volumes + diffusion | Xa | |||||||
Low-dose CT scan | Xa | |||||||
6-min walking distance | Xa | |||||||
Laboratory | ||||||||
CRP, hematology, chemistry, kidney and liver test | X | At clinician’s discretion | At clinician’s discretion | Xa | ||||
Pregnancy test for females of childbearing potential | X | |||||||
Viral qPCR (nasopharyngeal swab) | If feasible |
aIf clinically feasible
bQT monitoring scheme: Long QT (> 470 ms males and > 480 females) is an exclusion for participation. In patients with no long QT on ECG but at risk, a QT monitoring will be performed with intermittent ECG monitoring at days 2–3 or continuous follow-up on ICUs. When QTc > 500 ms and/or delta QTc > 60 ms, IMP will be interrupted/discontinued at the discretion of the investigator. The patient’s medication will be reviewed daily to evaluate DDIs including drugs prolonging the QTc interval according to what is listed in the protocol (see Additional file 1)