Clinical trial NCT04463602: Desidustat in the Management of COVID-19 Patients
Official title: A Phase 2b, Multicenter, Open-label, Randomized, Comparator-Controlled, Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Clinical status of subject on a 7-point ordinal scale
timeFrame: Week 2
Secondary outcomes:
measure: PCR test
timeFrame: Week 2 and Week 4
measure: Supplemental Oxygen
timeFrame: Week 2 and Week 4
measure: Mechanical Ventilation
timeFrame: Week 2 and Week 4
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Week 2 and Week 4
measure: Laboratory Assessments
timeFrame: Week 2 and Week 4
measure: C-reactive protein (CRP)
timeFrame: Week 2 and Week 4
measure: Interleukin 6 (IL-6)
timeFrame: Week 2 and Week 4
measure: D-dimer
timeFrame: Week 2 and Week 4
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Avant Sante Site 1
Study officials:
affiliation: Cadila Healthcare Ltd.
name: Dr Deven Parmar, MD
role: STUDY_DIRECTOR
References: