COVID-19
Conditions
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.
Interventions
DRUGDesidustat
100 mg once daily
OTHERStandard of Care
Standard of care as per local authority
Sponsors
Zydus Lifesciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| PCR test | Week 2 and Week 4 | PCR for SARS-CoV-2 in pharyngeal swab |
| 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 |
| Laboratory Assessments | Week 2 and Week 4 | Laboratory Assessments |
Countries
Mexico
Outcome results
None listed