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Desidustat in the Management of COVID-19 Patients

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Desidustat
Standard of Care
Sponsored by
Zydus Lifesciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Avant Sante Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desidustat + Standard of Care

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Clinical status of subject on a 7-point ordinal scale
Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities. Hospitalized, not requiring supplemental oxygen. Hospitalized, requiring supplemental oxygen. Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Death.

Secondary Outcome Measures

PCR test
PCR for SARS-CoV-2 in pharyngeal swab
Supplemental Oxygen
Occurrence of supplemental Oxygen
Mechanical Ventilation
Occurrence of Mechanical Ventilation
Incidence of Treatment-Emergent Adverse Events
Occurence of Adverse events
Laboratory Assessments
Laboratory Assessments
C-reactive protein (CRP)
Inflammatory Biomarker
Interleukin 6 (IL-6)
Inflammatory Biomarker
D-dimer
Inflammatory Biomarker

Full Information

First Posted
July 7, 2020
Last Updated
April 22, 2021
Sponsor
Zydus Lifesciences Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04463602
Brief Title
Desidustat in the Management of COVID-19 Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2020 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydus Lifesciences Limited

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desidustat + Standard of Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Control: Standard of care Standard of care treatment for the duration of 14 days at the time of conduct of trial.
Intervention Type
Drug
Intervention Name(s)
Desidustat
Intervention Description
100 mg once daily
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care as per local authority
Primary Outcome Measure Information:
Title
Change in Clinical status of subject on a 7-point ordinal scale
Description
Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities. Hospitalized, not requiring supplemental oxygen. Hospitalized, requiring supplemental oxygen. Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Death.
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
PCR test
Description
PCR for SARS-CoV-2 in pharyngeal swab
Time Frame
Week 2 and Week 4
Title
Supplemental Oxygen
Description
Occurrence of supplemental Oxygen
Time Frame
Week 2 and Week 4
Title
Mechanical Ventilation
Description
Occurrence of Mechanical Ventilation
Time Frame
Week 2 and Week 4
Title
Incidence of Treatment-Emergent Adverse Events
Description
Occurence of Adverse events
Time Frame
Week 2 and Week 4
Title
Laboratory Assessments
Description
Laboratory Assessments
Time Frame
Week 2 and Week 4
Title
C-reactive protein (CRP)
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
Interleukin 6 (IL-6)
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4
Title
D-dimer
Description
Inflammatory Biomarker
Time Frame
Week 2 and Week 4

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to comprehend and willingness to sign a written ICF by the subject/impartial witness. Male and Females, age ≥18 years at enrollment. Understands and agrees to comply with planned study procedures. Agrees to the collection of pharyngeal swabs and blood sample as per protocol. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray) Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam). 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: ALT/AST >5 times the upper limit of normal. Stage V CKD (i.e. eGFR <15 ml/min/1.73 m2 or requiring dialysis). Pregnant or breast feeding. 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. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. Prolong QT interval (>450 ms). Patients on invasive mechanical ventilation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Deven Parmar, MD
Organizational Affiliation
Cadila Healthcare Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Avant Sante Site 1
City
Monterrey
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Desidustat in the Management of COVID-19 Patients

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