Table 1.
Schedule of assessments performed at each observation point
| Observation items | Registration | Study intervention period‡ | Disconti nuation |
||||||||
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 14 | |||
| 1. Eligibility | 〇* | ||||||||||
| 2. Patients’ characteristics | 〇* | ||||||||||
| 3. Severity of COVID-19 pneumonia | 〇*, † | 〇 | 〇 | ||||||||
| 4. Vital signs | 〇*, † | 〇 | 〇 | 〇 | 〇 | ||||||
| 5. Quantity of oxygen administration | ← | 〇 | ← | 〇 | |||||||
| 6. PCR test for SARS-CoV-2 | 〇*, † | 〇 | 〇 | 〇 | |||||||
| 7. Haematology tests | 〇*, † | 〇 | 〇 | 〇 | 〇 | ||||||
| 8. General blood biochemical tests | 〇*, † | 〇 | 〇 | 〇 | 〇 | ||||||
| 9. Blood coagulation tests | 〇*, † | 〇 | 〇 | 〇 | 〇 | ||||||
| 10. Chest radiography and CT | 〇*, † | △ | △ | 〇 | 〇 | ||||||
| 11. Nasal drip tests | 〇* | 〇 | 〇 | 〇 | 〇 | ||||||
| 12. Special blood tests | 〇* | 〇 | 〇 | 〇 | 〇 | ||||||
| 13. Medication adherence of study agent | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | |||
| 14. Medications of other pharmaceutical agents | ← | 〇 | ← | ||||||||
| 15. Meal intake | ← | 〇 | ← | ||||||||
| 16. Subjective symptoms | ← | 〇 | ← | ||||||||
| 17. Adverse events | ← | 〇 | ← | ||||||||
| 18. Preservation of blood serum | 〇* | 〇 | 〇 | 〇 | 〇 | ||||||
〇=mandatory item; △=optional item.
*Data should be obtained before the administration of the study agent in the group A or B.
†Data obtained within 72 hours before consenting can be used in the all groups.
‡Length of hospital stay can be changed based on the subjects’ disease condition.