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AzTrials

SARS-CoV-2 CoronavirusHARMONICOVNCT04373200

Human Ab Response & immunoMONItoring of COVID-19 Patients

A study testing Blood samples collection and Saliva collection in people with SARS-CoV-2 Coronavirus and Acute Respiratory Distress Syndrome, run by Rennes University Hospital 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

Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood samples collection and Saliva collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteFrance
Study dates
25 May 2020to 9 Mar 2021
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

  • Patient older than 18 years old
  • Patients COVID-19 :
  • hospitalized for less than 48 hours in intensive care unit (ICU) with ARDS (PaO2/Fi02 < 200) or
  • hospitalized with respiratory syndrome without need of invasive mechanical ventilation
  • Patients hospitalized for less than 48 hours in intensive care unit (ICU) with ARDS (PaO2/Fi02 < 200) from other causes
  • Patients who have given their consent or included in an emergency situation
  • Patients affiliated to medical care insurance

Who cannot join

  • Pregnant women
  • Preexisting immune disorders (HIV-infection, malignancy, graft, treatment with immunosuppressive agents)
  • Patients legally protected (under judicial protection, guardianship), persons deprived of liberty

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Rennes

    Rennes, 35033

Other trials in France

About this study

Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution

Read the detailed description

Assessed by World Health Organisation as a pandemic on March 11, COVID-19 is caused by the SARS-CoV-2 coronavirus. The spectrum of its clinical manifestations is strikingly broad and extends from mild disease (resembling an ordinary bout of flu or even asymptomatic) to pneumonia. The latter cases convey a high risk of evolution towards acute respiratory distress syndrome (ARDS), eventually fatal when worsening with cytokine storm and multiple organ failure or with superinfection and sepsis. In the absence of overt variations of the virus itself, its interactions with the host immune system are likely crucial. Clinical features of patients with severe forms of COVID-19 were reported, but immunological description of biomarkers for exacerbation and mortality vs recovery remains superficial. Globally decreased white blood cells, notably T-cells, suggest that CoV-2 might trigger or exploit an immune defect. This could correspond to gaps in immune cell subpopulations, kinetics of activation or repertoires. Immune failure would then be responsible for exacerbations and a poor outcome in intensive care unit (ICU) patients. The objective of the study is to characterize the kinetics of the immune response and of immune dysregulation in ARDS patients. In addition to studying severe ARDS patients, an inverse image of immune repertoires should appear in healed up patients, after they have reached an undetectable viral load and acquired protective antibodies (Abs). Humoral immunity mediated by specific anti-viral Abs was a key factor for recovery from SARS-CoV-1 infection, and this is also expected for CoV-2, making the Ig repertoire also of special interest for its inclusion of anti-viral neutralizing Abs (nAbs).

Altogether, there is thus an urgent need for high-resolution characterization of the anti-CoV-2 immune response, correlating the dynamics of immune activation, cytokine production and immune repertoires with clinical evolution. In addition to providing biomarkers for prognosis evaluation and for monitoring innovative treatments this will also participate to the urgent quest of as many possible monoclonal antibodies (mAb) candidates for immunotherapy

Being tested
Blood samples collection, Saliva collection
Keywords
COVID-19, SARS-CoV-2 coronavirus, Acute Respiratory Distress Syndrome
Medical subject headings
Respiratory Distress Syndrome, COVID-19

What participants receive

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

  • Blood samples collectionBiological

    Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients

  • Saliva collectionOther

    Saliva collection at Month 4 for 25 survivors COVID-19 patients

Study groups in NCT04373200
Study groupRoleWhat they receive
COVID-19 patients with associated ARDSExperimentalNot described
Receives: Biological: Blood samples collection; Other: Saliva collection
COVID-19 patients without associated ARDSActive comparatorNot described
Receives: Biological: Blood samples collection; Other: Saliva collection
Patients with ARDS from other causesActive comparatorNot described
Receives: Biological: Blood samples collection

What is being measured

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

  1. Number of increased immune population

    Blood sample

    Measured: Month 4

  2. Number of decreased immune population

    Blood sample

    Measured: Month 4

  3. Number of statically different phenotypes compared to control patients

    Blood sample

    Measured: Month 4

Secondary outcomes (6)

  1. Gain or loss of functional phenotypic markers between D1 and D14

    Qualitative identification of immune subpopulations showing a significant variation compared to controls and quantification of this variation (at D1 and/or D14)

    Measured: Day 14

  2. Gain or loss of functional phenotypic markers between between acute and mild infections

    Qualitative identification of immune subpopulations showing a significant variation between acute and mild COVID-19 and quantification of this variation (at D1 and/or D14)

    Measured: Day 14

  3. Gain or loss of functional phenotypic markers between D1 and month 4

    Qualitative identification of immune subpopulations showing a significant variation between acute stage and recovery (at 4 months) and quantification of this variation

    Measured: Month 4

  4. Evaluation of V, D, J gene usage alterations in the immunoglobulin and T cell receptor (TCR) repertoires during ARDS linked to COVID-19

    Blood sample

    Measured: Day 14

  5. Identification of the Ig classes and of V, D, J sequences of anti-CoV-2 antibodies

    Blood sample

    Measured: Month 4

  6. Characterization of a new set of human antibodies from patients who have recovered of COVID-19

    Blood sample

    Measured: Month 4

Timeline

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

  1. First posted4 May 2020
  2. Study start25 May 2020
  3. Primary completion9 Mar 2021
  4. Study completion9 Mar 2021

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Comparative study with 3 cohorts of 25 adult patients: * Cohort A: 25 COVID-19 associated ARDS * Cohort B: 25 COVID-19 without ARDS * Cohort C: 25 ARDS from other causes
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373200
Sponsor's protocol ID
35RC20_9795_HARMONICOV
Other IDs
2020-A01100-39
Acronym
HARMONICOV
Status last verified
May 2023
First submitted
22 Apr 2020
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pascal V, Dupont M, de Rouault P, Rizzo D, Rossille D, Jeannet R, Daix T, Francois B, Genebrier S, Cornic M, Monneret G, Venet F, Ferrant J, Roussel M, Reizine F, Le Souhaitier M, Tadie JM, Tarte K, Feuillard J, Cogne M. Demultiplexing Ig repertoires by parallel mRNA/DNA sequencing shows major differential alterations in severe COVID-19. iScience. 2023 Mar 17;26(3):106260. doi: 10.1016/j.isci.2023.106260. Epub 2023 Feb 21.

    PubMed 36845033

  • Roussel M, Ferrant J, Reizine F, Le Gallou S, Dulong J, Carl S, Lesouhaitier M, Gregoire M, Bescher N, Verdy C, Latour M, Bezier I, Cornic M, Vinit A, Monvoisin C, Sawitzki B, Leonard S, Paul S, Feuillard J, Jeannet R, Daix T, Tiwari VK, Tadie JM, Cogne M, Tarte K. Comparative immune profiling of acute respiratory distress syndrome patients with or without SARS-CoV-2 infection. Cell Rep Med. 2021 Jun 15;2(6):100291. doi: 10.1016/j.xcrm.2021.100291. Epub 2021 May 6.

    PubMed 33977279

  • Hamzeh-Cognasse H, Mansour A, Reizine F, Mismetti P, Gouin-Thibault I, Cognasse F. Platelet-derived sCD40L: specific inflammatory marker for early-stage severe acute respiratory syndrome coronavirus 2 infection. Virol J. 2021 Oct 29;18(1):211. doi: 10.1186/s12985-021-01680-3.

    PubMed 34715884

Questions about this trial

What is this clinical trial studying?

A study testing Blood samples collection and Saliva collection in people with SARS-CoV-2 Coronavirus and Acute Respiratory Distress Syndrome, run by Rennes University Hospital 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 7 inclusion and 3 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 23 May 2023. 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?

Number of increased immune population (time frame: Month 4). The study lists 3 primary outcomes in all. 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 NCT04373200, which also lists 3 linked publications.

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 23 May 2023.

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