Covid19NCT04477902
Long-Term Experience and Health Effects of COVID-19
An observational study of Covid19 and Corona Virus Infection, run by Altura at 1 site in United States.
Trial summary
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Corona Virus Infection, Quality of Life
- What is being tested?
- none - observational
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 22 Jun 2021
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anyone in the USA can participate in this study that meets inclusion criteria. To ensure diversity urban, suburban and rural areas of the country will be included.
Who may be able to join
- 18 years of age or older
- Any gender specification
- Has consented to proceed with survey
- Is able to complete the survey via email on a regular basis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.
Read the detailed description
Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.
This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.
The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.
To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.
- Conditions
- Covid19, Corona Virus Infection, Quality of Life, Risk Reduction
- Being tested
- none - observational
- Keywords
- covid-19, corona virus, covid19, coronavirus, SARS-CoV-2, infection, household, transmission, vaccine, clinical trials, online, Altura, outpatient, telemedicine
- Medical subject headings
- COVID-19, Coronavirus Infections, Risk Reduction Behavior, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none - observationalOther
online survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal survey
To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jul 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete Fronte, MBA, Study chair, Altura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477902
- Sponsor's protocol ID
- altcovid-192020
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects
- ClinicalTrials.gov ID
- NCT04477902
- Acronym / sponsor ID
- altcovid-192020
- Conditions
- Covid19, Corona Virus Infection, Quality of Life, Risk Reduction
- Keywords
- covid-19, corona virus, covid19, coronavirus, SARS-CoV-2, infection, household, transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AlturaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 20 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.
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.
Detailed description
Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.
This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.
The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.
To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone in the USA can participate in this study that meets inclusion criteria. To ensure diversity urban, suburban and rural areas of the country will be included.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Any gender specification
- Has consented to proceed with survey
- Is able to complete the survey via email on a regular basis
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| none - observationalonline survey | Other | – |
Primary outcome
Longitudinal survey
Time frame: 2 years
To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.
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 24 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Pete Fronte, MBA study chair
Altura
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 Covid19 and Corona Virus Infection, run by Altura 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 4 inclusion and 1 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 24 Jun 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 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?
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?
Longitudinal survey (time frame: 2 years). 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 24 Jun 2021.