Desidustat in the Management of COVID-19 Patients

NCT04463602 | Completed Phase 2 DMC

• 1 other identifier: DESI.20.004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in Clinical status of subject on a 7-point ordinal scale

  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.

  Week 2

Secondary Outcomes (8)

• PCR test

  Week 2 and Week 4

• Supplemental Oxygen

  Week 2 and Week 4

• Mechanical Ventilation

  Week 2 and Week 4

• Incidence of Treatment-Emergent Adverse Events

  Week 2 and Week 4

• Laboratory Assessments

  Week 2 and Week 4

Study Arms (2)

Desidustat + Standard of Care

EXPERIMENTAL

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; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Desidustat DRUG

100 mg once daily

Desidustat + Standard of Care

Standard of Care OTHER

Standard of care as per local authority

Desidustat + Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Avant Sante Site 1

Monterrey, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

desidustat; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dr Deven Parmar, MD

  Cadila Healthcare Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: July 25, 2020
• Primary Completion: January 25, 2021
• Study Completion: March 31, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)