Coronavirus InfectionPhase 4GOTCHANCT04473274
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
A Phase 4 study testing Pioglitazone in people with Coronavirus Infection and Diabetes, run by Samaritan Health Services at 1 site in United States.
Trial summary
Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, Diabetes
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 1 Dec 2020
- Phase
- Phase 4
- 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
- 18 years or older
- Laboratory confirmed COVID-19 requiring hospitalization
- A1c greater than 5.6% as measured in the last 30 days
- Women of child-bearing potential who agree to use highly effective method of contraception (defined as either abstinence, condom, diaphragm, and/or oral or injected hormonal contraception) during dosing and for 30 days after last dose
- MRSA PCR screen negative
Who cannot join
- Pregnancy or nursing
- Congestive Heart Failure all classes (NYHA Class I, II, III or IV)
- Liver enzyme ALT greater than 2.5 times upper limit of normal
- End stage renal disease
- Hypersensitivity or allergy to a TZD (thiazolidinedione)
- Active bladder cancer
- Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD
- Other current or historical illness that in the opinion of the investigator at attending provider would interfere with the subject's ability to complete the study or make it not in the best interest of the subject to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
About this study
Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.
- Conditions
- Coronavirus Infection, Diabetes
- Being tested
- Pioglitazone
- Keywords
- COVID19, Diabetes, COVID-19, Coronavirus
- Medical subject headings
- Coronavirus Infections, Diabetes Mellitus, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Receive pioglitazone 15mg - 30mg daily
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone group | Experimental | Participants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care Receives: Drug: Pioglitazone |
| Matching cohort group | No intervention | Participants will standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events outcomes without attribution
Number and type of adverse events
Measured: Baseline, until 30 days after last dose
Adverse events attributable
Number and type of adverse events
Measured: Baseline, until 30 days after last dose
Secondary outcomes (7)
Clinical improvement
Disease severity as measured by 7 point ordinal scale
Measured: Baseline, until 30 days after last dose
Levels of treatment
Type of oxygen support treatment
Measured: Baseline, until 30 days after last dose
d-Dimer
Change from Baseline of d-Dimer
Measured: Baseline, until 30 days after last dose
C Reactive Protein
Change from Baseline of CRP
Measured: Baseline, until 30 days after last dose
Ferritin
Change from Baseline of Ferritin
Measured: Baseline, until 30 days after last dose
Lactate dehydrogenase
Change from Baseline of Lactate dehydrogenase
Measured: Baseline, until 30 days after last dose
A1c
Change from Baseline of A1c
Measured: Baseline, until 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start21 May 2020
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Matching cohort
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samaritan Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Delmonaco, MD, Principal investigator, Samaritan Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473274
- Sponsor's protocol ID
- IRB20-042
- Acronym
- GOTCHA
- Status last verified
- Dec 2020
- First submitted
- 22 Jun 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT04473274
- Acronym / sponsor ID
- GOTCHA / IRB20-042
- Conditions
- Coronavirus Infection, Diabetes
- Keywords
- COVID19, Diabetes, COVID-19, Coronavirus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samaritan Health ServicesUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 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.
Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matching cohort
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone group | Experimental | Drug: PioglitazoneParticipants will receive pioglitazone 15mg to 30mg daily oral or enteral during hospitalization for up to 30 days in addition to standard of care |
| Matching cohort group | No intervention | –Participants will standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Laboratory confirmed COVID-19 requiring hospitalization
- A1c greater than 5.6% as measured in the last 30 days
- Women of child-bearing potential who agree to use highly effective method of contraception (defined as either abstinence, condom, diaphragm, and/or oral or injected hormonal contraception) during dosing and for 30 days after last dose
- MRSA PCR screen negative
Key exclusion criteria (8 listed)
- Pregnancy or nursing
- Congestive Heart Failure all classes (NYHA Class I, II, III or IV)
- Liver enzyme ALT greater than 2.5 times upper limit of normal
- End stage renal disease
- Hypersensitivity or allergy to a TZD (thiazolidinedione)
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 |
|---|---|---|
| PioglitazoneReceive pioglitazone 15mg - 30mg daily | Drug | Pioglitazone group |
Primary outcome
Adverse events outcomes without attribution
Time frame: Baseline, until 30 days after last dose
Number and type of adverse events
Adverse events attributable
Time frame: Baseline, until 30 days after last dose
Number and type of adverse events
7 secondary outcomes
Clinical improvement
Time frame: Baseline, until 30 days after last dose
Levels of treatment
Time frame: Baseline, until 30 days after last dose
d-Dimer
Time frame: Baseline, until 30 days after last dose
C Reactive Protein
Time frame: Baseline, until 30 days after last dose
Ferritin
Time frame: Baseline, until 30 days after last dose
Lactate dehydrogenase
Time frame: Baseline, until 30 days after last dose
A1c
Time frame: Baseline, until 30 days after last dose
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 4 Dec 2020.
- 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.
Brian Delmonaco, MD principal investigator
Samaritan Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone in people with Coronavirus Infection and Diabetes, run by Samaritan Health Services at 1 site in United States.
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 5 inclusion and 8 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 4 Dec 2020. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Adverse events outcomes without attribution (time frame: Baseline, until 30 days after last dose). The study lists 2 primary outcomes in all. 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 4 Dec 2020.