SARS-CoV-2COVID19PUGG2NCT04343781
National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19
An observational study of SARS-CoV-2 and COVID-19, run by University Hospital, Angers at 1 site in France.
Trial summary
Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- observation
- How many people
- 353 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2020to 5 Apr 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: all older French patients infected by SARS-CoV-2
Who may be able to join
- confirmed COVID-19 defined by a positive RT-PCR to SARS-CoV-2
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients.
Read the detailed description
This cross-sectional survey was initiated and conducted by the French Society of Geriatrics and Gerontology. A standardized questionnaire was emailed to 1600 geriatrician members of the French Society of Geriatrics and Gerontology throughout France between March 22, 2020 and April 5, 2020. Geriatricians were asked to complete the survey for their last 10 patients infected by the SARS-CoV-2. The study was declared to the Commission Nationale de l'Informatique et des Libertés (CNIL) under the number ar20-0031v1.
For each patient, demographic characteristics (age, gender, residence place, care place, autonomy according to the Groupe Iso Ressource (GIR)), medical history (presence of major neurocognitive disorder, hypertension, diabetes, asthma or chronic obstructive pulmonary disease (COPD), heart pathology, severe renal failure with a clearance of creatinine under 30ml/min, solid or liquid cancer) were collected. The symptoms within de 72 hours of the actual disease were also collected for each patient including geriatric syndromes (fall, hypoactive or hyperactive delirium, altered general status, altered conscience), general symptoms (temperature, blood pressure), respiratory symptoms (cough, polypnea), ear nose and throat (ENT) symptoms (rhinorrhea, odynophagia, otalgia, conjunctivitis, ageusia or dysgeusia, anosmia), digestive symptoms (diarrhea, nausea or vomiting), and blood formula modification (leucopenia (with count if available), lymphopenia (with count if available), thrombopenia (with count if available).
Procedure Data were collected by the physician who was in charge of the patient between March 22, 2020 and April 5, 2020.
Given the main objective of the study was only descriptive, no calculation was required concerning the number of subjects to include in the study.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- observation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation of clinical symptoms related to COVID-19 disease
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of COVID-19 in older patients
description and identification of symptoms presented by older patients with confirmed COVID-19
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start22 Mar 2020
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
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 SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cross-sectional
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric Annweiler, M.D., Ph.D., Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343781
- Sponsor's protocol ID
- ar20-0031v1
- Acronym
- COVID19PUGG2
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annweiler C, Sacco G, Salles N, Aquino JP, Gautier J, Berrut G, Guerin O, Gavazzi G. National French Survey of Coronavirus Disease (COVID-19) Symptoms in People Aged 70 and Over. Clin Infect Dis. 2021 Feb 1;72(3):490-494. doi: 10.1093/cid/ciaa792.
PubMed 32556328
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04343781
- Acronym / sponsor ID
- COVID19PUGG2 / ar20-0031v1
- Conditions
- SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 13 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.
Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients.
Detailed description
This cross-sectional survey was initiated and conducted by the French Society of Geriatrics and Gerontology. A standardized questionnaire was emailed to 1600 geriatrician members of the French Society of Geriatrics and Gerontology throughout France between March 22, 2020 and April 5, 2020. Geriatricians were asked to complete the survey for their last 10 patients infected by the SARS-CoV-2. The study was declared to the Commission Nationale de l'Informatique et des Libertés (CNIL) under the number ar20-0031v1.
For each patient, demographic characteristics (age, gender, residence place, care place, autonomy according to the Groupe Iso Ressource (GIR)), medical history (presence of major neurocognitive disorder, hypertension, diabetes, asthma or chronic obstructive pulmonary disease (COPD), heart pathology, severe renal failure with a clearance of creatinine under 30ml/min, solid or liquid cancer) were collected. The symptoms within de 72 hours of the actual disease were also collected for each patient including geriatric syndromes (fall, hypoactive or hyperactive delirium, altered general status, altered conscience), general symptoms (temperature, blood pressure), respiratory symptoms (cough, polypnea), ear nose and throat (ENT) symptoms (rhinorrhea, odynophagia, otalgia, conjunctivitis, ageusia or dysgeusia, anosmia), digestive symptoms (diarrhea, nausea or vomiting), and blood formula modification (leucopenia (with count if available), lymphopenia (with count if available), thrombopenia (with count if available).
Procedure Data were collected by the physician who was in charge of the patient between March 22, 2020 and April 5, 2020.
Given the main objective of the study was only descriptive, no calculation was required concerning the number of subjects to include in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all older French patients infected by SARS-CoV-2
Key inclusion criteria (1 listed)
- confirmed COVID-19 defined by a positive RT-PCR to SARS-CoV-2
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 |
|---|---|---|
| observationobservation of clinical symptoms related to COVID-19 disease | Other | – |
Primary outcome
symptoms of COVID-19 in older patients
Time frame: at baseline
description and identification of symptoms presented by older patients with confirmed COVID-19
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 16 Jun 2020.
- Derived from this study: PubMed 32556328Annweiler C, Sacco G, Salles N, Aquino JP, Gautier J, Berrut G, Guerin O, Gavazzi G. National French Survey of Coronavirus Disease (COVID-19) Symptoms in People Aged 70 and Over. Clin Infect Dis. 2021 Feb 1;72(3):490-494. doi: 10.1093/cid/ciaa792.
- 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.
Cédric Annweiler, M.D., Ph.D. principal investigator
University Hospital, Angers
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 SARS-CoV-2 and COVID-19, run by University Hospital, Angers at 1 site in France.
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 1 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 16 Jun 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 France. 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?
symptoms of COVID-19 in older patients (time frame: at baseline). 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 NCT04343781, 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 16 Jun 2020.