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. 2021 Sep 21;11(9):e053325. doi: 10.1136/bmjopen-2021-053325

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 *
 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.