Coronavirus InfectionNCT04353401
WGS Analysis of COVID-19 Positive Patients
An observational study of Coronavirus Infection and COVID-19, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, COVID-19
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 9 Mar 2022
- 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: COVID-19 positive patients
Who may be able to join
- Ability and acceptance to provide written informed consent and fluent in English.
- Men or women between 18-100+ years, inclusive.
- Willing to comply with study procedures.
- SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Genome Sequencing Analysis of of SARS-CoV-2 Positive Patients
We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.
- Conditions
- Coronavirus Infection, COVID-19
- Keywords
- Covid-19, WGS, viral load, viral genome
- Medical subject headings
- Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations with severity and outcomes
Clinical associations with human and viral genetics
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start3 Aug 2020
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
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.
- More trials run by Vanda PharmaceuticalsThe 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
- Other
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353401
- Sponsor's protocol ID
- VP-01-01
- Other IDs
- CALYPSO
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2020
- Last updated
- 22 Mar 2024
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genome Sequencing Analysis of of SARS-CoV-2 Positive Patients
- ClinicalTrials.gov ID
- NCT04353401
- Acronym / sponsor ID
- VP-01-01
- Conditions
- Coronavirus Infection, COVID-19
- Keywords
- Covid-19, WGS, viral load, viral genome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 20 Apr 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.
We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 positive patients
Key inclusion criteria (4 listed)
- Ability and acceptance to provide written informed consent and fluent in English.
- Men or women between 18-100+ years, inclusive.
- Willing to comply with study procedures.
- SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).
Key exclusion criteria (0 listed)
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
Associations with severity and outcomes
Time frame: 3 months
Clinical associations with human and viral genetics
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 22 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronavirus Infection and COVID-19, run by Vanda Pharmaceuticals 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 0 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 22 Mar 2024. 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?
Associations with severity and outcomes (time frame: 3 months). 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 22 Mar 2024.