Covid19Pro-Co-HPANCT04858581
Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
A study testing Virological and serological tests in people with Covid19, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019. In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Virological and serological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2021to Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Healthcare workers over 18 years of age
- Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
- Healthcare workers with signed consent
Who cannot join
- Protected healthcare workers
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital privé d'Antony
Paris, 92160
Jean-Charles Gagnard, 0146744380, jeancharles.gagnard@gmail.com
Jean-Charles Gagnard
About this study
Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019.
In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%).
Read more
An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19.
Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.
Read the detailed description
The scientific and medical world is mobilizing to accelerate the production of knowledge on this virus, on the disease it causes as well as the means of curing and preventing it. But no one yet knows how much it can cause immunological changes in the body. For some specialists, this virus is even much more than a viral infection and causes a general disruption of the immune system.
Faced with the COVID-19 pandemic, healthcare workers are a particularly exposed.
The main objective of this research is to assess the presence of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test of healthcare workers.
- Conditions
- Covid19
- Being tested
- Virological and serological tests
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virological and serological testsDiagnostic test
Survey, RT-PCR test and blood test
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2 | Other | Survey, RT-PCR test and blood test. Receives: Diagnostic Test: Virological and serological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of symptoms attributed to COVID-19 at 6 months.
The primary outcome is the description of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test.
Measured: 6 months after COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Gagnard, Principal investigator, Hôpital privé d'Antony
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858581
- Sponsor's protocol ID
- 2020-A02720-39
- Acronym
- Pro-Co-HPA
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
- ClinicalTrials.gov ID
- NCT04858581
- Acronym / sponsor ID
- Pro-Co-HPA / 2020-A02720-39
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Apr 2021 (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.
Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019.
In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%).
An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19.
Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.
Detailed description
The scientific and medical world is mobilizing to accelerate the production of knowledge on this virus, on the disease it causes as well as the means of curing and preventing it. But no one yet knows how much it can cause immunological changes in the body. For some specialists, this virus is even much more than a viral infection and causes a general disruption of the immune system.
Faced with the COVID-19 pandemic, healthcare workers are a particularly exposed.
The main objective of this research is to assess the presence of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test of healthcare workers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2 | Other | Diagnostic Test: Virological and serological testsSurvey, RT-PCR test and blood test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthcare workers over 18 years of age
- Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
- Healthcare workers with signed consent
Key exclusion criteria (2 listed)
- Protected healthcare workers
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| Virological and serological testsSurvey, RT-PCR test and blood test | Diagnostic test | Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2 |
Primary outcome
Description of symptoms attributed to COVID-19 at 6 months.
Time frame: 6 months after COVID-19 infection
The primary outcome is the description of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
Jean-Charles Gagnard principal investigator
Hôpital privé d'Antony
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virological and serological tests in people with Covid19, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 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 16 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Charles GAGNARD (0146744380, jeancharles.gagnard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of symptoms attributed to COVID-19 at 6 months. (time frame: 6 months after COVID-19 infection). 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 16 Sep 2021.