COVID-19COPANCT05471011
COVID-19 Outcome Prediction Algorithm
An observational study of COVID-19 and Post Acute Sequelae of COVID-19, run by University of California, Los Angeles at 7 sites in United States.
Trial summary
Severe acute respiratory syndrome coronavirus 2-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Post Acute Sequelae of COVID-19, Long COVID
- What is being tested?
- Blood and nasal swab sampling
- How many people
- 600 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Aug 2022to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Symptomatic COVID-19 infected civilians and symptomatic COVID-19 infected veterans
Who may be able to join
- Symptomatic COVID-19 infection with hospital admission
- Age 18 and above
- Informed consent
Who cannot join
- Absence of symptomatic COVID-19 infection with hospital admission
- Age 17 or below
- No informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Atlanta VA Medical Center
Decatur, Georgia, 30033
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Olive View-UCLA Education & Research Institute
Sylmar, California, 91342
Bronx VA Medical Center
The Bronx, New York, 10468
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Multi-Dimensional Outcome Prediction Algorithm for Hospitalized COVID-19 Patients
Severe acute respiratory syndrome coronavirus 2-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. We propose to develop a test that accurately predicts short- and long-term (within one-year) outcomes in hospitalized COVID-19 patients broadly reflecting US demographics who are at increased risk of adverse outcomes from COVID-19 using both clinical and molecular data. We will enroll patients from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. Several high risk COVID-19 populations have been identified. Older adults, males, persons of color, and those with certain underlying health conditions (e.g., diabetes mellitus, obesity, etc.) are at higher risk for severe disease from COVID-19. While it is too soon to fully understand the impact of COVID-19 on overall health and well-being, there are already several reports of significant sequelae, which appear to correlate with disease severity. There is a clear and urgent need to develop prediction tests for adverse short- and long-term outcomes, especially for high-risk COVID-19 populations. We hypothesize that complementary multi-dimensional information gathered near the time of symptom onset can be used to predict new onset or worsening frailty, organ dysfunction and death within one year after COVID-19 onset. A single parameter provides limited information and is incapable of adequately characterizing the complex biological responses in symptomatic COVID-19 to predict outcome. Since they were designed for other illnesses, it is unlikely that existing clinical tools, such as respiratory, cardiovascular, and other organ function assessment scores, will precisely assess the long-term prognosis of this novel disease. Our extensive experience in biomarker development suggests that integrating molecular and clinical data increases prediction accuracy of long-term outcomes. We have chosen to test our hypothesis in a population reflecting US-demographics that is at increased risk of adverse outcomes from COVID-19. We will enroll patients, broadly reflecting US demographics, from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population. We anticipate that a prediction test that performs well in this hospitalized patient group will: help guide triaging and treatment decisions and, therefore, reduce morbidity and mortality rates, enhance patient quality of life, and improve healthcare cost-effectiveness. More accurate prognostic information will also assist clinicians in framing goals of care discussions in situations of likely futility and assist patients and families in this decision-making process. Finally, it will provide a logical means for allocating resources in short supply, such as ventilators or therapeutics with limited availability.
- Conditions
- COVID-19, Post Acute Sequelae of COVID-19, Long COVID, Organ Dysfunction Syndrome, Multiple, Frailty Syndrome
- Being tested
- Blood and nasal swab sampling
- Keywords
- outcome prediction, systems biology, multiomics, algorithm, veterans, high-risk populations
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Multiple Organ Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and nasal swab samplingOther
Blood and nasal swab sampling
| Study group | Role | What they receive |
|---|---|---|
| civilian | Not described Receives: Other: Blood and nasal swab sampling | |
| Veteran | Not described Receives: Other: Blood and nasal swab sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year
The primary outcome clinical composite endpoints that include new onset or worsening frailty, single organ dysfunction, multi organ dysfunction, and death within one year will include a follow-up period of time of at least 52 weeks after initial enrollment encounter. The assessment of time to event (outcome events will include various frailty measurement tools including short physical performance battery, laboratory test-based organ function assessment measures, and survival status as per publicly-accessible databases) will consist of calculating the time difference between first outcome event and baseline encounter date.
Measured: From hospital admission to one year
Secondary outcomes (1)
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death at time of discharge
The secondary outcome clinical composite endpoints that include new onset or worsening frailty, single organ dysfunction, multi organ dysfunction, and death within the time from initial encounter to the time of discharge will include a follow-up period consisting of the time from initial enrollment encounter to the time of discharge. The assessment of time to event (outcome events will include various frailty measurement tools including short physical performance battery, laboratory test-based organ function assessment measures, and survival status as per publicly-accessible databases) will consist of calculating the time difference between first outcome event and baseline encounter date.
Measured: From hospital admission to time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start8 Aug 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Olive View-UCLA Education & Research Institute, VA Greater Los Angeles Healthcare System, Michael E. DeBakey VA Medical Center, Atlanta VA Medical Center, Bronx VA Medical Center
- Responsible party
- Principal investigator, Mario C. Deng, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471011
- Sponsor's protocol ID
- 1R01AI159946-01A1
- Acronym
- COPA
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After our data is cleaned, quality checked, and analyzed, we will make the data available to the general research community. Data collected in this proposal will be submitted to the appropriate public databases (e.g. Gene Expression Omnibus), along with complete documentation to enable efficient use of the data by the general research community. Cumulative datasets will be submitted on a regular basis in a timely manner. All data made available for public use will be de-identified data, i.e., stripped of private, protected health information that could be used to deduce the identity of individual subjects, in compliance with the HIPPA Privacy Rule. The study will be registered in the database of Genotypes and Phenotypes and the following data and information will be shared through the Sequence Read Archive and Gene Expression Omnibus.
Publications
Deng MC. Multi-dimensional COVID-19 short- and long-term outcome prediction algorithm. Expert Rev Precis Med Drug Dev. 2020;5(4):239-242. doi: 10.1080/23808993.2020.1785286. Epub 2020 Jun 24. No abstract available.
PubMed 33283045
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Dimensional Outcome Prediction Algorithm for Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05471011
- Acronym / sponsor ID
- COPA / 1R01AI159946-01A1
- Conditions
- COVID-19, Post Acute Sequelae of COVID-19, Long COVID, Organ Dysfunction Syndrome, Multiple, Frailty Syndrome
- Keywords
- outcome prediction, systems biology, multiomics, algorithm, veterans, high-risk populations
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Olive View-UCLA Education & Research Institute, VA Greater Los Angeles Healthcare System, Michael E. DeBakey VA Medical Center, Atlanta VA Medical Center, Bronx VA Medical Center
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Jul 2022 (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.
Severe acute respiratory syndrome coronavirus 2-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. We propose to develop a test that accurately predicts short- and long-term (within one-year) outcomes in hospitalized COVID-19 patients broadly reflecting US demographics who are at increased risk of adverse outcomes from COVID-19 using both clinical and molecular data. We will enroll patients from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. Several high risk COVID-19 populations have been identified. Older adults, males, persons of color, and those with certain underlying health conditions (e.g., diabetes mellitus, obesity, etc.) are at higher risk for severe disease from COVID-19. While it is too soon to fully understand the impact of COVID-19 on overall health and well-being, there are already several reports of significant sequelae, which appear to correlate with disease severity. There is a clear and urgent need to develop prediction tests for adverse short- and long-term outcomes, especially for high-risk COVID-19 populations. We hypothesize that complementary multi-dimensional information gathered near the time of symptom onset can be used to predict new onset or worsening frailty, organ dysfunction and death within one year after COVID-19 onset. A single parameter provides limited information and is incapable of adequately characterizing the complex biological responses in symptomatic COVID-19 to predict outcome. Since they were designed for other illnesses, it is unlikely that existing clinical tools, such as respiratory, cardiovascular, and other organ function assessment scores, will precisely assess the long-term prognosis of this novel disease. Our extensive experience in biomarker development suggests that integrating molecular and clinical data increases prediction accuracy of long-term outcomes. We have chosen to test our hypothesis in a population reflecting US-demographics that is at increased risk of adverse outcomes from COVID-19. We will enroll patients, broadly reflecting US demographics, from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population. We anticipate that a prediction test that performs well in this hospitalized patient group will: help guide triaging and treatment decisions and, therefore, reduce morbidity and mortality rates, enhance patient quality of life, and improve healthcare cost-effectiveness. More accurate prognostic information will also assist clinicians in framing goals of care discussions in situations of likely futility and assist patients and families in this decision-making process. Finally, it will provide a logical means for allocating resources in short supply, such as ventilators or therapeutics with limited availability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| civilian | – | Other: Blood and nasal swab sampling |
| Veteran | – | Other: Blood and nasal swab sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic COVID-19 infected civilians and symptomatic COVID-19 infected veterans
Key inclusion criteria (3 listed)
- Symptomatic COVID-19 infection with hospital admission
- Age 18 and above
- Informed consent
Key exclusion criteria (3 listed)
- Absence of symptomatic COVID-19 infection with hospital admission
- Age 17 or below
- No informed consent
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 |
|---|---|---|
| Blood and nasal swab samplingBlood and nasal swab sampling | Other | Veteran, civilian |
Primary outcome
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year
Time frame: From hospital admission to one year
The primary outcome clinical composite endpoints that include new onset or worsening frailty, single organ dysfunction, multi organ dysfunction, and death within one year will include a follow-up period of time of at least 52 weeks after initial enrollment encounter. The assessment of time to event (outcome events will include various frailty measurement tools including short physical performance battery, laboratory test-based organ function assessment measures, and survival status as per publicly-accessible databases) will consist of calculating the time difference between first outcome event and baseline encounter date.
1 secondary outcome
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death at time of discharge
Time frame: From hospital admission to time of discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 33283045Deng MC. Multi-dimensional COVID-19 short- and long-term outcome prediction algorithm. Expert Rev Precis Med Drug Dev. 2020;5(4):239-242. doi: 10.1080/23808993.2020.1785286. Epub 2020 Jun 24. No abstract available.
- Individual participant dataSharing planned: Yes. After our data is cleaned, quality checked, and analyzed, we will make the data available to the general research community. Data collected in this proposal will be submitted to the appropriate public databases (e.g. Gene Expression Omnibus), along with complete documentation to enable efficient use of the data by the general research community. Cumulative datasets will be submitted on a regular basis in a timely manner. All data made available for public use will be de-identified data, i.e., stripped of private, protected health information that could be used to deduce the identity of individual subjects, in compliance with the HIPPA Privacy Rule. The study will be registered in the database of Genotypes and Phenotypes and the following data and information will be shared through the Sequence Read Archive and Gene Expression Omnibus.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Post Acute Sequelae of COVID-19, run by University of California, Los Angeles at 7 sites 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year (time frame: From hospital admission to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471011, which also lists 1 linked publication.
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 24 Apr 2026.