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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
100 mg once daily
Standard of care as per local authority
Avant Sante Site 1
Monterrey, Mexico
Change in Clinical status of subject on a 7-point ordinal scale
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.
Time frame: Week 2
PCR test
PCR for SARS-CoV-2 in pharyngeal swab
Time frame: Week 2 and Week 4
Supplemental Oxygen
Occurrence of supplemental Oxygen
Time frame: Week 2 and Week 4
Mechanical Ventilation
Occurrence of Mechanical Ventilation
Time frame: Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events
Occurence of Adverse events
Time frame: Week 2 and Week 4
Laboratory Assessments
Laboratory Assessments
Time frame: Week 2 and Week 4
C-reactive protein (CRP)
Inflammatory Biomarker
Time frame: Week 2 and Week 4
Interleukin 6 (IL-6)
Inflammatory Biomarker
Time frame: Week 2 and Week 4
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D-dimer
Inflammatory Biomarker
Time frame: Week 2 and Week 4