Host-pathogen Interactions During SARS-CoV-2 Infection (NCT04376476) | Clinical Trial Compass
CompletedNot Applicable
Host-pathogen Interactions During SARS-CoV-2 Infection
France140 participantsStarted 2020-05-05
Plain-language 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.
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.
Who can participate
Age range
1 Day – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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);
* 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
Exclusion Criteria:
Group E1:
* Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initial biological profile of children with COVID-19 infection
Timeframe: Day 0
2
Initial immunological profile of children with COVID-19 infection