Desidustat in the Management of COVID-19 Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Desidustat
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desidustat + Standard of Care<br>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<br>* 100 mg once daily<br>Other: Standard of Care<br>* Standard of care as per local authority<br>|
| Active Comparator: Standard of Care<br>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<br>* Standard of care as per local authority<br>|

What is the study measuring?
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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 |