COVID-19Phase 2NCT04463602
Desidustat in the Management of COVID-19 Patients
A Phase 2 study testing Desidustat in people with COVID-19, run by Zydus Lifesciences Limited at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Desidustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 25 Jul 2020to 31 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Desidustat, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesidustatDrug
100 mg once daily
Standard of CareOther
Standard of care as per local authority
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Desidustat; Other: Standard of Care |
| 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2
Secondary outcomes (8)
PCR test
PCR for SARS-CoV-2 in pharyngeal swab
Measured: Week 2 and Week 4
Supplemental Oxygen
Occurrence of supplemental Oxygen
Measured: Week 2 and Week 4
Mechanical Ventilation
Occurrence of Mechanical Ventilation
Measured: Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events
Occurence of Adverse events
Measured: Week 2 and Week 4
Laboratory Assessments
Laboratory Assessments
Measured: Week 2 and Week 4
C-reactive protein (CRP)
Inflammatory Biomarker
Measured: Week 2 and Week 4
Interleukin 6 (IL-6)
Inflammatory Biomarker
Measured: Week 2 and Week 4
D-dimer
Inflammatory Biomarker
Measured: Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start25 Jul 2020
- Primary completion25 Jan 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study director, Cadila Healthcare Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463602
- Sponsor's protocol ID
- DESI.20.004
- Status last verified
- Apr 2021
- First submitted
- 7 Jul 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04463602
- Acronym / sponsor ID
- DESI.20.004
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desidustat + Standard of Care | Experimental | Drug: Desidustat, Other: Standard of CareTest: 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 | Other: Standard of CareControl: Standard of care Standard of care treatment for the duration of 14 days at the time of conduct of trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desidustat100 mg once daily | Drug | Desidustat + Standard of Care |
| Standard of CareStandard of care as per local authority | Other | Desidustat + Standard of Care, Standard of Care |
Primary outcome
Change in Clinical status of subject on a 7-point ordinal scale
Time frame: 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.
8 secondary outcomes
PCR test
Time frame: Week 2 and Week 4
Supplemental Oxygen
Time frame: Week 2 and Week 4
Mechanical Ventilation
Time frame: Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events
Time frame: Week 2 and Week 4
Laboratory Assessments
Time frame: Week 2 and Week 4
C-reactive protein (CRP)
Time frame: Week 2 and Week 4
Interleukin 6 (IL-6)
Time frame: Week 2 and Week 4
D-dimer
Time frame: Week 2 and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Deven Parmar, MD study director
Cadila Healthcare Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desidustat in people with COVID-19, run by Zydus Lifesciences Limited at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical status of subject on a 7-point ordinal scale (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.