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Desidustat in the Management of COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04463602
Recruitment Status : Active, not recruiting
First Posted : July 9, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Brief Summary:
This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Desidustat Other: Standard of Care Phase 2

Detailed Description:
This is a phase 2b, multicenter, open-label, randomized, comparator-controlled clinical trial to evaluate the efficacy and safety of Desidustat for the management of COVID-19 patients. First 12 mild to moderate subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care, 06 subjects) will be enrolled in the study and after evaluation of safety of these 12 subjects by Data Monitoring Committee other 12 severe subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care arm, 06 subjects) will be enrolled in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Open-label, Randomized, Comparator-Controlled, Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID-19 Patients
Actual Study Start Date : July 25, 2020
Estimated Primary Completion Date : January 25, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Desidustat + Standard of Care

Test: Desidustat + Standard of care

Desidustat 100 mg for the duration of 14 days along with the recommended standard of care at the time of conduct of trial.

Drug: Desidustat
100 mg once daily

Other: Standard of Care
Standard of care as per local authority

Active Comparator: Standard of Care

Control: Standard of care

Standard of care treatment for the duration of 14 days at the time of conduct of trial.

Other: Standard of Care
Standard of care as per local authority




Primary Outcome Measures :
  1. Change in Clinical status of subject on a 7-point ordinal scale [ Time Frame: Week 2 ]
    1. Not hospitalized, no limitations on activities.
    2. Not hospitalized, limitation on activities.
    3. Hospitalized, not requiring supplemental oxygen.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
    6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    7. Death.


Secondary Outcome Measures :
  1. PCR test [ Time Frame: Week 2 and Week 4 ]
    PCR for SARS-CoV-2 in pharyngeal swab

  2. Supplemental Oxygen [ Time Frame: Week 2 and Week 4 ]
    Occurrence of supplemental Oxygen

  3. Mechanical Ventilation [ Time Frame: Week 2 and Week 4 ]
    Occurrence of Mechanical Ventilation

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Week 2 and Week 4 ]
    Occurence of Adverse events

  5. Laboratory Assessments [ Time Frame: Week 2 and Week 4 ]
    Laboratory Assessments

  6. C-reactive protein (CRP) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  7. Interleukin 6 (IL-6) [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker

  8. D-dimer [ Time Frame: Week 2 and Week 4 ]
    Inflammatory Biomarker



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to comprehend and willingness to sign a written ICF by the subject/impartial witness.
  2. Male and Females, age ≥18 years at enrollment.
  3. Understands and agrees to comply with planned study procedures.
  4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
  5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week.
  6. Illness of any duration, and at least one of the following:

    1. Radiographic infiltrates by imaging (chest x-ray)
    2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
  7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

Exclusion Criteria:

  1. ALT/AST >5 times the upper limit of normal.
  2. Stage V CKD (i.e. eGFR <15 ml/min/1.73 m2 or requiring dialysis).
  3. Pregnant or breast feeding.
  4. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
  5. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
  6. Prolong QT interval (>450 ms).
  7. Patients on invasive mechanical ventilation.

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): NCT04463602


Locations
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Mexico
Avant Sante Site 1
Monterrey, Mexico
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
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Study Director: Dr Deven Parmar, MD Cadila Healthcare Ltd.
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Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT04463602    
Other Study ID Numbers: DESI.20.004
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No