Status:
COMPLETED
Desidustat in the Management of COVID-19 Patients
Lead Sponsor:
Zydus Lifesciences Limited
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 COV...
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 t...
Eligibility Criteria
Inclusion
- 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:
- Radiographic infiltrates by imaging (chest x-ray)
- Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
- 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
- ALT/AST \>5 times the upper limit of normal.
- Stage V CKD (i.e. eGFR \<15 ml/min/1.73 m2 or requiring dialysis).
- Pregnant or breast feeding.
- 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.
- Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
- Prolong QT interval (\>450 ms).
- Patients on invasive mechanical ventilation.
Key Trial Info
Start Date :
July 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04463602
Start Date
July 25 2020
End Date
March 31 2021
Last Update
April 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Avant Sante Site 1
Monterrey, Mexico