COVIDNCT04378881
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
An observational study of COVID and Drug Effect, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Drug Effect, Drug Interaction
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2020to 11 Nov 2023
- Phase
- Observational
- 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
Study population: The number of patients will change. 95,717 patients with Medicare/Medicaid health plan and 528,436 from commercial population.
Who may be able to join
- Patients enrolled with Cambia Health Solutions; Medicare/Medicaid or Commercial Health Insurance Plan
- Patients with drug claims available from 10/01/2018 to 10/31/2019
Who cannot join
- Patients with no drug claims available for 2018
- Health Plan for injectable drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
Orlando, Florida, 32827
About this study
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance population. Our clinical tool would enable us to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in these patients infected with COVID-19.
Read the detailed description
Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide, and the new investigational drug remdesivir, have been proposed for repurposing to fight COVID-19 and its complications.
A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 and the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data for commercially insured patients.
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Keywords
- COVID-19, Repurposed Drug, Drug Interaction, LQTS
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen via our proprietary risk stratification process.
Quantitative
Measured: Three months
Simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen via our proprietary risk stratification process.
Quantitative
Measured: Three months
Compare the impact (change) on the Medication Risk Score using the calculate before score and simulated after score following the addition of repurposed drugs for COVID-19 to the drug regimens of patients enrolled in the study.
Quantitative
Measured: Three months
Measure the effects of various repurposed drugs for COVID-19 on each of the five factors computed by algorithms to derive the Medication Risk Score will be calculated via our proprietary risk stratification process.
Quantitative
Measured: Three months
Secondary outcomes (2)
Comparison of the Medication Risk Score and the effects of the addition of repurposed drugs on the drug regimen between participants with Medicare/Medicaid vs. commercial health insurance plans will be assessed.
Qualitative
Measured: Six months
Measure the effects on Medication Risk Score of various repurposed drugs for COVID-19 within subgroups of patients classified by specific diseases or drugs used and the impact of various covariables.
Qualitative
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start12 Jun 2020
- Primary completion11 Jun 2023 (estimated)
- Study completion11 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambia Health Solutions
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378881
- Sponsor's protocol ID
- COVID19-TRHC-2020-002
- Status last verified
- Sep 2022
- First submitted
- 5 May 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
- ClinicalTrials.gov ID
- NCT04378881
- Acronym / sponsor ID
- COVID19-TRHC-2020-002
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Keywords
- COVID-19, Repurposed Drug, Drug Interaction, LQTS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Collaborators
- Cambia Health Solutions
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 11 Jun 2023 (estimated)
- Study completion
- 11 Nov 2023 (estimated)
- First posted
- 7 May 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 retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance population. Our clinical tool would enable us to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in these patients infected with COVID-19.
Detailed description
Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide, and the new investigational drug remdesivir, have been proposed for repurposing to fight COVID-19 and its complications.
A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 and the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data for commercially insured patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The number of patients will change. 95,717 patients with Medicare/Medicaid health plan and 528,436 from commercial population.
Key inclusion criteria (2 listed)
- Patients enrolled with Cambia Health Solutions; Medicare/Medicaid or Commercial Health Insurance Plan
- Patients with drug claims available from 10/01/2018 to 10/31/2019
Key exclusion criteria (2 listed)
- Patients with no drug claims available for 2018
- Health Plan for injectable drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculate the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen via our proprietary risk stratification process.
Time frame: Three months
Quantitative
Simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen via our proprietary risk stratification process.
Time frame: Three months
Quantitative
Compare the impact (change) on the Medication Risk Score using the calculate before score and simulated after score following the addition of repurposed drugs for COVID-19 to the drug regimens of patients enrolled in the study.
Time frame: Three months
Quantitative
Measure the effects of various repurposed drugs for COVID-19 on each of the five factors computed by algorithms to derive the Medication Risk Score will be calculated via our proprietary risk stratification process.
Time frame: Three months
Quantitative
2 secondary outcomes
Comparison of the Medication Risk Score and the effects of the addition of repurposed drugs on the drug regimen between participants with Medicare/Medicaid vs. commercial health insurance plans will be assessed.
Time frame: Six months
Measure the effects on Medication Risk Score of various repurposed drugs for COVID-19 within subgroups of patients classified by specific diseases or drugs used and the impact of various covariables.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- 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.
Veronique Michaud principal investigator
Tabula Rasa HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Drug Effect, run by Tabula Rasa HealthCare 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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.
Are results available for this study?
Results are not available in the source record.
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?
Calculate the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen via our proprietary risk stratification process. (time frame: Three months). The study lists 4 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 2 Sep 2022.