Desidustat in the Management of COVID-19 Patients

NCT ID: NCT04463602

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-25
• Study Completion Date: 2021-03-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Desidustat

Intervention Type: DRUG

100 mg once daily

Standard of Care

Intervention Type: OTHER

Standard of care as per local authority

Standard of Care

Control: Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of care as per local authority

Interventions

Desidustat

100 mg once daily

Intervention Type: DRUG

Standard of Care

Standard of care as per local authority

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zydus Lifesciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Deven Parmar, MD

Role: STUDY_DIRECTOR

Cadila Healthcare Ltd.

Locations

Avant Sante Site 1

Monterrey, , Mexico

Countries

Mexico

Other Identifiers

DESI.20.004

Identifier Type: -

Identifier Source: org_study_id