Infection, CoronavirusHPI-COVID-19NCT04376476
Host-pathogen Interactions During SARS-CoV-2 Infection
A study testing Blood sample, Low or upper respiratory tract sample and Stool collection or fecal swab in people with Infection, Coronavirus and Severe Acute Respiratory Syndrome Coronavirus 2, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Infection, Coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Blood sample, Low or upper respiratory tract sample and Stool collection or fecal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 12 sitesFrance
- Study dates
- 5 May 2020to 13 May 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Group E1:
- Age from birth to <18 years old;
- Weight> 3 kilogram (kg);
- Infection with SARS-CoV-2 virus confirmed by RT-PCR on upper respiratory tract sample
- No fever or respiratory symptoms;
- Not requiring hospitalization (or hospitalization not related to a SARS-CoV-2 infection);
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- Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- Beneficiary of a social security scheme
- Group E2:
- Age from birth to <18 years old;
- Weight> 3kg;
- Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample or pneumonia with scanner suggesting SARS-CoV-2 infection;
- Hospitalized in a pediatric intensive care unit or in a general pediatrics unit
- Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- Beneficiary of a social security scheme
- Group E3:
- Age from birth to <18 years old;
- Weight> 3 kg;
- Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection
- Hospitalized in a pediatric intensive care unit or in a general pediatrics unit, for a respiratory reason;
- Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- Beneficiary of a social security scheme
Who cannot join
- Group E1:
- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- Other Suspected or proved infection
- Pregnancy.
- Group E2:
- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
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- Pregnancy.
- Group E3:
- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- Infection with the SARS-CoV-2 virus known among the relatives
- Pregnancy.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Groupement Hospitalier Nord-Daupine
Bourgoin, 38300
Hôpital femme-mère-enfant
Bron, 69677
Hôpital Louis Pradel
Bron, 69677
Hôpital Louis Mourier
Colombes, 92700
Centre Hospitalier D'Annecy-Genevois
Épagny, 74370
Centre Hospitalo-Universitaire de Grenoble
La Tronche, 38700
Hopital de la Croix-Rousse
Lyon, 69317
Hôpital Edouard Herriot
Lyon, 69437
Hôpital mère - enfant Nantes
Nantes, 44093
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital Nord de Saint Etienne
Saint-Priest-en-Jarez, 42270
Hôpital Nord-Ouest
Villefranche-sur-Saône, 69655
About this study
Official title: Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.
In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.
Read more
Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.
In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
- Being tested
- Blood sample, Low or upper respiratory tract sample, Stool collection or fecal swab, phone call
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, immunology, interferon, coronavirus
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Low or upper respiratory tract sampleBiological
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Stool collection or fecal swabBiological
The stool collection or fecal swab will be collected in order to take virology measurements:
Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0
phone callOther
phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
| Study group | Role | What they receive |
|---|---|---|
| Children group E1 | Experimental | Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14. Receives: Biological: Blood sample; Biological: Low or upper respiratory tract sample; Other: phone call |
| Children group E2 | Experimental | Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized). Receives: Biological: Blood sample; Biological: Low or upper respiratory tract sample; Biological: Stool collection or fecal swab |
| Children group E3 | Experimental | Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14. Receives: Biological: Blood sample; Biological: Low or upper respiratory tract sample; Biological: Stool collection or fecal swab; Other: phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial biological profile of children with COVID-19 infection
Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation
measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Measured: Day 0
Initial immunological profile of children with COVID-19 infection
measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
Measured: Day 0
Secondary outcomes (8)
Clinical worsening
Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection
Measured: Within 21 days following inclusion
Evolution of the immunological profile of children with COVID-19
measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening
Measured: Within 21 days following inclusion
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
Measured: Day 0
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measured: Day 0
titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measured: Day 0
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
Measured: Within 21 days following inclusion
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measured: Within 21 days following inclusion
titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measured: Within 21 days following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start5 May 2020
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, CoronavirusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376476
- Sponsor's protocol ID
- 69HCL20_0342
- Other IDs
- 2020-A01102-37
- Acronym
- HPI-COVID-19
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2020
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT04376476
- Acronym / sponsor ID
- HPI-COVID-19 / 69HCL20_0342
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, immunology, interferon, coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 6 May 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 new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.
In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.
Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.
In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children group E1 | Experimental | Biological: Blood sample, Biological: Low or upper respiratory tract sample, Other: phone callChildren with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14. |
| Children group E2 | Experimental | Biological: Blood sample, Biological: Low or upper respiratory tract sample, Biological: Stool collection or fecal swabChildren with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized). |
| Children group E3 | Experimental | Biological: Blood sample, Biological: Low or upper respiratory tract sample, Biological: Stool collection or fecal swab, Other: phone callChildren with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Age from birth to <18 years old;
- Weight> 3 kilogram (kg);
- Infection with SARS-CoV-2 virus confirmed by RT-PCR on upper respiratory tract sample
- No fever or respiratory symptoms;
- Not requiring hospitalization (or hospitalization not related to a SARS-CoV-2 infection);
Key exclusion criteria (11 listed)
- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- Other Suspected or proved infection
- Pregnancy.
- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- Pregnancy.
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 |
|---|---|---|
| Blood sampleblood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0 | Biological | Children group E1, Children group E2, Children group E3 |
| Low or upper respiratory tract sampleLow or upper respiratory tract sample will be collected in order to take virology measurements: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0 | Biological | Children group E1, Children group E2, Children group E3 |
| Stool collection or fecal swabThe stool collection or fecal swab will be collected in order to take virology measurements: Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0 | Biological | Children group E2, Children group E3 |
| phone callphone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14 | Other | Children group E1, Children group E3 |
Primary outcome
Initial biological profile of children with COVID-19 infection
Time frame: Day 0
Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Initial immunological profile of children with COVID-19 infection
Time frame: Day 0
measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
8 secondary outcomes
Clinical worsening
Time frame: Within 21 days following inclusion
Evolution of the immunological profile of children with COVID-19
Time frame: Within 21 days following inclusion
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Time frame: Day 0
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Time frame: Day 0
titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19
Time frame: Day 0
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Time frame: Within 21 days following inclusion
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Time frame: Within 21 days following inclusion
titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19
Time frame: Within 21 days following inclusion
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 5 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Low or upper respiratory tract sample and Stool collection or fecal swab in people with Infection, Coronavirus and Severe Acute Respiratory Syndrome Coronavirus 2, run by Hospices Civils de Lyon at 12 sites 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 22 inclusion and 11 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Initial biological profile of children with COVID-19 infection (time frame: Day 0). The study lists 2 primary outcomes in all. 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 5 Apr 2023.