Desidustat in the Management of COVID-19 Patients

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Healthcare Limited

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.