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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desidustat + Standard of Care | Experimental | 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 | Active Comparator | Control: Standard of care Standard of care treatment for the duration of 14 days at the time of conduct of trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desidustat | Drug | 100 mg once daily |
| |
| Standard of Care |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical status of subject on a 7-point ordinal scale |
| Week 2 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Deven Parmar, MD | Cadila Healthcare Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avant Sante Site 1 | Monterrey | Mexico |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000623340 | desidustat |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Other |
Standard of care as per local authority |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |