Table 1

Schedule of assessments performed at each observation point

Observation itemsRegistrationStudy intervention period‡Disconti
nuation
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 14
 1. Eligibility*
 2. Patients’ characteristics*
 3. Severity of COVID-19 pneumonia*, †
 4. Vital signs*, †
 5. Quantity of oxygen administration
 6. PCR test for SARS-CoV-2*, †
 7. Haematology tests*, †
 8. General blood biochemical tests*, †
 9. Blood coagulation tests*, †
 10. Chest radiography and CT*, †
 11. Nasal drip tests*
 12. Special blood tests*
 13. Medication adherence of study agent
 14. Medications of other pharmaceutical agents
 15. Meal intake
 16. Subjective symptoms
 17. Adverse events
 18. Preservation of blood serum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.