Table 1.
Assessment details and days of implementation.
| Assessment | Screening period | Administration period |
Observation period | Suspension |
| Hematologic testa | Day 1 | Days 4 and 8 | Day 15: implemented as an outpatient examination when the research subject has been discharged. Days 22 and 29: unnecessary when the research subject has been discharged. |
Unnecessary when the research subject has been discharged |
| Biochemical blood inspectionb | Day 1 | Days 4 and 8 | Day 15: implemented as an outpatient examination when the research subject has been discharged. Days 22 and 29: unnecessary when the research subject has been discharged. |
Unnecessary when the research subject has been discharged |
| Infectious disease inspectionc | Day 1 | Not implemented | Not implemented | Not implemented |
| Coagulation testd | Day 1 | Days 4 and 8 | Day 15: implemented as an outpatient examination when the research subject has been discharged. Days 22 and 29: unnecessary when the research subject has been discharged. |
Unnecessary when the research subject has been discharged |
| Coronavirus inspectione | Day 1 | Day 8 | Day 15: implemented as an outpatient examination when the research subject has been discharged. | Implemented when suspended before Day 8 |
| Image inspectionf | Day 1 | Day 8 | Day 15 Days 22 and 29: unnecessary when the research subject has been discharged. |
Implemented when suspended before Day 8 |
| Peak flow measurementg | Day 1 | Performed daily | Days 15, 22, and 29 | Not implemented |
| Questionnaireh | Day 1 | Subjective symptoms recorded daily | Day 15: implemented as an outpatient examination when the research subject has been discharged. Days 22 and 19: obtained by phone when the research subject has been discharged. |
Obtained by phone when the research subject has been discharged |
| Comprehensive assessment by the physician | Day 1 | Day 8 | Day 15: implemented as an outpatient examination when the research subject has been discharged. Days 22 and 29: unnecessary when the research subject has been discharged. |
Unnecessary when the research subject has been discharged |
| Confirmation of combined drug usage conditionsi | Not implemented | Information on the presence of concomitant medications collected daily | Days 15, 22, and 29 | Not implemented |
aLeukocyte count, neutrophil count, lymphocyte count, hematocrit level, hemoglobin level, platelet count, and blood sedimentation are to be measured for the hematologic tests.
bAlbumin, bilirubin, aspartate transaminase, alanine transaminase, lactate dehydrogenase, γ-glutamyl transpeptidase, alkaline phosphatase, creatinine kinase, creatinine, blood urea nitrogen, sodium, potassium, C-reactive protein, glutamic acid, and procalcitonin levels are to be measured for biochemical blood inspections.
cHepatitis B surface antigens, hepatitis B core antibodies, hepatitis C virus antibodies, and HIV antibodies are to be measured for infectious disease inspections.
dProthrombin time, activated partial thromboplastin time, fibrinogen level, and D-dimer level are to be measured for coagulation tests.
eFor coronavirus inspections, SARS-CoV-2 real-time polymerase chain reaction samples are to be collected with nasal swabs and measured on the day of and 8 days after hospitalization, and serum SARS-CoV-2 antibodies are to be measured on the day of and 8 days after hospitalization.
fChest computed tomography scans are to be taken on the day of and 8 days after hospitalization, and simple chest radiographs are to be taken 4, 8, 15, 22, and 29 days after hospitalization. In addition, image inspections will be conducted as necessary when symptom exacerbation is suspected. Simple chest radiographs on days 22 and 29 will not be taken if the research subject is already discharged. Computed tomography is to be performed when pneumonia worsens within 8 days of hospitalization and when the research is suspended.
gPeak expiratory flow is to be measured every morning with a peak flow meter during hospitalization and recorded in a diary.
hTo be conducted prior to assessment by the physician (eg, before the examination).
iInformation on drug and treatments other than the trial drug are to be collected.