Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04713176
Collaborator
(none)
1,022
1
2
4.9
210.2

Study Details

Study Description

Brief Summary

Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients

Condition or Disease Intervention/Treatment Phase
  • Drug: DWJ1248 with Remdesivir
  • Drug: Placebo with Remdesivir
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1022 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: DWJ1248 with Remdesivir

Camostat mesylate 200 mg, Remdesivir

Drug: DWJ1248 with Remdesivir
PO, 1 tablet of DWJ1248 TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)

Placebo Comparator: Placebo with Remdesivir

Placebo, Remdesivir

Drug: Placebo with Remdesivir
PO, 1 tablet of placebo TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)

Outcome Measures

Primary Outcome Measures

  1. Rate of mortality or ECMO patients [Up to 29 days]

    Percentage of patients with mortality(ordinal scale of 8) or ECMO patients(ordinal scale of 7)

Secondary Outcome Measures

  1. Recovery days [Day 3,5,8,11,15,22,29]

  2. 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

  3. Hospitalization period [Day 29]

    The duration of hospitalization (days)

  4. Rate of Mortality [Day 15,29]

    The percent of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Medical Center Seoul Korea, Republic of 04564

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT04713176
Other Study ID Numbers:
  • DW_DWJ1248302
First Posted:
Jan 19, 2021
Last Update Posted:
Mar 3, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2021