Covid19ALCOVIDNCT04525911
Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital
A study testing Diagnostic Test: serology test for COVID-19 in people with Covid19, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Diagnostic Test: serology test for COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2020to 13 Feb 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
- Aged ≥ 18 years,
- Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
- Having given free and informed written consent,
- Being affiliated with or benefiting from a social security scheme.
- Patients / caregivers may be included in several ancillary studies at the same time.
Who cannot join
- -Subject to a measure for the protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.
- Conditions
- Covid19
- Being tested
- Diagnostic Test: serology test for COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: serology test for COVID-19Diagnostic test
a serology test will be performed at M3
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic COVID-19 infection confirmed or probable | Experimental | Patients and medical staff having symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria) Receives: Diagnostic Test: Diagnostic Test: serology test for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
measure used to assess symptoms of post-traumatic stress disorder. Individuals should rate their experience with each of the 17 symptoms of PTSD on a scale of 1 to 5 (1 = not at all, 2 = a little, 3 = moderately, 4 = a little, and 5 = extremely) versus to a specific traumatic event
Measured: 3 months
Secondary outcomes (4)
Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers
Measured: 12 and 24 months
Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population
Measured: 12 and 24 months
% of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)
Measured: 3 months
Comparison of M0 chest CT results at each follow-up for the entire study population
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start26 Aug 2020
- Primary completion9 Feb 2022
- Study completion13 Feb 2023
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé PEGLIASCO, Principal investigator, Hôpital Europeen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525911
- Sponsor's protocol ID
- 2020- A01647-32
- Acronym
- ALCOVID
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escoda T, Chiche L, Faralli H, Cohen F, Halfon P, Pegliasco H, Rebaudet S; ALCOVID consortium. Cluster analysis of post-COVID-19 physical and mental health outcomes 3-6 months after SARS-CoV-2 infection: results of the French Prospective ALCOVID Cohort Study. BMJ Open. 2025 Feb 11;15(2):e089136. doi: 10.1136/bmjopen-2024-089136.
PubMed 39933809
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital
- ClinicalTrials.gov ID
- NCT04525911
- Acronym / sponsor ID
- ALCOVID / 2020- A01647-32
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 25 Aug 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 the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic COVID-19 infection confirmed or probable | Experimental | Diagnostic Test: Diagnostic Test: serology test for COVID-19Patients and medical staff having symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years,
- Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
- Having given free and informed written consent,
- Being affiliated with or benefiting from a social security scheme.
- Patients / caregivers may be included in several ancillary studies at the same time.
Key exclusion criteria (1 listed)
- -Subject to a measure for the protection of justice
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 |
|---|---|---|
| Diagnostic Test: serology test for COVID-19a serology test will be performed at M3 | Diagnostic test | Symptomatic COVID-19 infection confirmed or probable |
Primary outcome
Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
Time frame: 3 months
measure used to assess symptoms of post-traumatic stress disorder. Individuals should rate their experience with each of the 17 symptoms of PTSD on a scale of 1 to 5 (1 = not at all, 2 = a little, 3 = moderately, 4 = a little, and 5 = extremely) versus to a specific traumatic event
4 secondary outcomes
Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers
Time frame: 12 and 24 months
Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population
Time frame: 12 and 24 months
% of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)
Time frame: 3 months
Comparison of M0 chest CT results at each follow-up for the entire study population
Time frame: 24 months
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 29 Oct 2026.
- Background: PubMed 39933809Escoda T, Chiche L, Faralli H, Cohen F, Halfon P, Pegliasco H, Rebaudet S; ALCOVID consortium. Cluster analysis of post-COVID-19 physical and mental health outcomes 3-6 months after SARS-CoV-2 infection: results of the French Prospective ALCOVID Cohort Study. BMJ Open. 2025 Feb 11;15(2):e089136. doi: 10.1136/bmjopen-2024-089136.
- 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.
Hervé PEGLIASCO principal investigator
Hôpital Europeen Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: serology test for COVID-19 in people with Covid19, run by Hôpital Européen Marseille 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 5 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 29 Oct 2026. 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?
Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers (time frame: 3 months). 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 NCT04525911, 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 29 Oct 2026.