Desidustat in the Management of COVID-19 Patients

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463602
• Other study ID #: DESI.20.004
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Cadila Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 31, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Desidustat
100 mg once daily

Other:
• Standard of Care
Standard of care as per local authority

Locations

Country	Name	City	State
Mexico	Avant Sante Site 1	Monterrey

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Healthcare Limited

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical status of subject on a 7-point ordinal scale	Not hospitalized, no limitations on activities.; Not hospitalized, limitation on activities.; Hospitalized, not requiring supplemental oxygen.; Hospitalized, requiring supplemental oxygen.; Hospitalized, on non-invasive ventilation or high flow oxygen devices.; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).; Death.	Week 2
Secondary	PCR test	PCR for SARS-CoV-2 in pharyngeal swab	Week 2 and Week 4
Secondary	Supplemental Oxygen	Occurrence of supplemental Oxygen	Week 2 and Week 4
Secondary	Mechanical Ventilation	Occurrence of Mechanical Ventilation	Week 2 and Week 4
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurence of Adverse events	Week 2 and Week 4
Secondary	Laboratory Assessments	Laboratory Assessments	Week 2 and Week 4
Secondary	C-reactive protein (CRP)	Inflammatory Biomarker	Week 2 and Week 4
Secondary	Interleukin 6 (IL-6)	Inflammatory Biomarker	Week 2 and Week 4
Secondary	D-dimer	Inflammatory Biomarker	Week 2 and Week 4