Severe COVID-19
Conditions
Brief summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Interventions
DRUGDWJ1248 with Remdesivir
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
DRUGPlacebo with Remdesivir
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over the age of 19 as of the signed date in written consent * Subjects with COVID-19 according to RT-PCR test(within 10 days) * Subjects who need to be hospitalized and injected Remdesivir
Exclusion criteria
* Subjects who cannot orally administer the investigational products * Subjects who requiring mechanical ventilation or ECMO * Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome * Subjects who need administration of immunosuppressants * Subjects who are allergic or sensitive to investigational products or its ingredients * Crcl \< 30 mL/min or eGFR \< 30 mL/min/1.73m\^2 * AST or ALT \>= 5xULN * Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days | Up to 29 days | Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery | Day 3,5,8,11,15,22,29 | — |
| Desirable of Outcome Ranking (DOOR) | Day 15,29 | The DOOR is scored by evaluating two items: ordinal scale and serious adverse events. DOORs are as follows: 1: Recovery (corresponding to the ordinal scale of 1, 2, or 3); 2: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with no serious adverse events; 3: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with serious adverse events; 4: No change (no change in the ordinal scale compared to baseline) with no serious adverse events; 5: No change (no change in the ordinal scale compared to baseline) with serious adverse event regardless of causality; 6: Deterioration (increased by more than 1 score of the ordinal scale compared to baseline); 7: Death |
| Duration of Hospitalization | Day 29 | The duration of hospitalization (days) |
| Time to death | Day 15,29 | The percent of participants |
Countries
South Korea
Outcome results
None listed