Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 (2) | ||
---|---|---|---|---|---|---|---|---|
Patient screening | Treatment start | Hospitalization | Efficacy assessment | Hospital discharge | Study end | |||
Days of treatment | Day 1 | Day 2 | Day 3 (last dose) | |||||
Days since the beginning of treatment administration | Day 0 | Day 1 | Day 2 | Day 3 | Day 10 (±1) | Day 28 (±3) from hospital discharge | ||
Obtaining informed consent | ✔ | |||||||
Eligibility criteria assessment | ✔ | |||||||
Demographic data | ✔ | |||||||
Acute illness information (SARS-CoV-2 pneumonia): | ✔ | ✔ | ||||||
▫ New-onset radiological infiltrates (4) | ||||||||
▫ RT-PCR or antigen testing: positive | ||||||||
General examination [respiratory parameters, fever] (5) | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
General laboratory tests (6) | ✔ | ✔ | ✔ | ✔ | ✔(1) | ✔ | ✔(1) | ✔(1) |
12-lead EKG | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
▫ Patient Clinical Status Scale | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
▫ Clinical Severity Assessment Scale | ||||||||
Treatment administration | ✔ | ✔ | ✔ | |||||
Biomarker samples | ✔(3) | ✔ | ✔ | ✔ | ✔ | ✔ | ||
AE, SAE and SUSAR notification | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
Concomitant treatment recording | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |