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

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ClinicalTrials.gov Identifier: NCT04713176
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Severe COVID-19 Drug: DWJ1248 with Remdesivir Drug: Placebo with Remdesivir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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)




Primary Outcome Measures :
  1. Rate of mortality or ECMO patients [ Time Frame: 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 [ Time Frame: Day 3,5,8,11,15,22,29 ]
  2. Desirable of Outcome Ranking (DOOR) [ Time Frame: 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 [ Time Frame: Day 29 ]
    The duration of hospitalization (days)

  4. Rate of Mortality [ Time Frame: Day 15,29 ]
    The percent of participants



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713176


Locations
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Korea, Republic of
National Medical Center Recruiting
Seoul, Korea, Republic of, 04564
Contact: Jae-Hyun Jeon       mdjjh@nmc.or.kr   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04713176    
Other Study ID Numbers: DW_DWJ1248302
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No