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.
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.
Drug: Desidustat
100 mg once daily
Other: Standard of Care
Standard of care as per local authority
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.
Avant Sante Site 1
Monterrey, Mexico
Dr Deven Parmar, MD, Study Director
Cadila Healthcare Ltd.