Desidustat in the Management of COVID-19 Patients

• ClinicalTrials.gov Identifier: NCT04463602
• Recruitment Status: Active, not recruiting
• First Posted: July 9, 2020
• Last Update Posted: December 14, 2020
• Sponsor: Cadila Healthcare Limited
• Information provided by (Responsible Party): Cadila Healthcare Limited

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Mexico

Avant Sante Site 1

Monterrey, Mexico

Sponsors and Collaborators

Cadila Healthcare Limited

Investigators

• Study Director: Dr Deven Parmar, MD; Cadila Healthcare Ltd.

More Information

• Responsible Party: Cadila Healthcare Limited
• ClinicalTrials.gov Identifier: NCT04463602
• Other Study ID Numbers: DESI.20.004
• First Posted: July 9, 2020
• Last Update Posted: December 14, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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