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Severe SARS-CoV2 PneumoniaNCT04376840

Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19

A study testing Blood sample and data record in people with Severe SARS-CoV2 Pneumonia, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe SARS-CoV2 Pneumonia
What is being tested?
Blood sample and data record
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
28 May 2020to 29 Jul 2022
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

  • Adult patient
  • Patient with with severe SARS-CoV2 pneumonia
  • Patient consenting to participate to the study
  • Patient enrolled in the national healthcare insurance program

Who cannot join

  • Patient under 18 years

Trial locations and contacts

1 site in 1 country.

France1 site
  • Damien JOLLY

    Reims

Other trials in France

About this study

Official title: Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia

Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions.

Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function.

Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

Read the detailed description

Objective is to evaluate prevalence of long-term respiratory complications after severe SARS-CoV2 pneumonia.

Being tested
Blood sample and data record
Keywords
SARS-CoV2, long term, complication, pneumonia
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sample and data recordOther

    Blood sample and data record

Study groups in NCT04376840
Study groupRoleWhat they receive
adults with severe SARS-CoV2 pneumoniaExperimentaladult with severe SARS-CoV2 pneumonia
Receives: Other: Blood sample and data record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. medium-term respiratory complications

    Interstitial lung disease diagnosed with a thoracic CT-scan

    Measured: 3 months

Secondary outcomes (1)
  1. long-term respiratory complications

    Interstitial lung disease diagnosed with a thoracic CT-scan

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2020
  2. Study start28 May 2020
  3. Primary completion29 Jul 2022
  4. Study completion29 Jul 2022

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04376840
Sponsor's protocol ID
PO20066
Status last verified
Sep 2024
First submitted
4 May 2020
Last updated
21 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perotin JM, Gierski F, Bolko L, Dury S, Barriere S, Launois C, Dewolf M, Chouabe S, Bongrain E, Picard D, Tran E, N'Guyen Y, Mourvillier B, Servettaz A, Rapin A, Marcus C, Lebargy F, Kaladjian A, Salmon JH, Deslee G. Cluster analysis unveils a severe persistent respiratory impairment phenotype 3-months after severe COVID-19. Respir Res. 2022 Aug 2;23(1):199. doi: 10.1186/s12931-022-02111-9.

    PubMed 35918719

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample and data record in people with Severe SARS-CoV2 Pneumonia, run by CHU de Reims 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 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 21 Jan 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?

medium-term respiratory complications (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 NCT04376840, 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 21 Jan 2026.

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