Desidustat in the Management of COVID-19 Patients

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Desidustat; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Monterrey, Mexico
    • Avant Sante Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR test	PCR for SARS-CoV-2 in pharyngeal swab	Week 2 and Week 4
Supplemental Oxygen	Occurrence of supplemental Oxygen	Week 2 and Week 4
Mechanical Ventilation	Occurrence of Mechanical Ventilation	Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events	Occurence of Adverse events	Week 2 and Week 4
Laboratory Assessments	Laboratory Assessments	Week 2 and Week 4
C-reactive protein (CRP)	Inflammatory Biomarker	Week 2 and Week 4
Interleukin 6 (IL-6)	Inflammatory Biomarker	Week 2 and Week 4
D-dimer	Inflammatory Biomarker	Week 2 and Week 4

Collaborators and Investigators

• Sponsor: Zydus Lifesciences Limited
• Investigators: Study Director: Dr Deven Parmar, MD, Cadila Healthcare Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DESI.20.004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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