Desidustat in the Management of COVID-19 Patients

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Desidustat; Other: Standard of Care

• Registration Number: NCT04463602
• Lead Sponsor: Zydus Lifesciences Limited

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.

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Study Start: 2020-07-25
• Primary Completion: 2021-01-25
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desidustat + Standard of Care	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.
Desidustat + Standard of Care	Desidustat	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.
Standard of Care	Standard of Care	Control: Standard of care Standard of care treatment for the duration of 14 days at the time of conduct of trial.

Primary Outcome Measures

Name	Time	Method
Change in Clinical status of subject on a 7-point ordinal scale	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

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

Trial Locations

Locations (1)

Avant Sante Site 1; 🇲🇽 Monterrey, Mexico