NCT04376476: HPI-COVID-19

Host-pathogen Interactions During SARS-CoV-2 Infection

Completed NA Last updated 5 April 2023

What this trial tests

NA trial testing Blood sample in Infection, Coronavirus in 140 participants. Completed in 13 May 2022.

Timeline

5 May 2020

Primary endpoint
13 May 2022

13 May 2022

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	140
Start date	5 May 2020
Primary completion	13 May 2022
Estimated completion	13 May 2022
Sites	12 locations across France

Drugs / interventions tested

• Blood sample — full drug profile →
• Low or upper respiratory tract sample — full drug profile →
• Stool collection or fecal swab — full drug profile →
• phone call

Conditions studied

• Infection, Coronavirus — all drugs for Infection, Coronavirus →
• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 1 Day to 18, any sex, with Infection, Coronavirus or Severe Acute Respiratory Syndrome Coronavirus 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of COVID-19 studies registered in the clinical trial platforms: A research ethics analysis perspective.
   Buruk B, Guner MD, Ekmekci PE, Celebi AS. · · 2022 · cited 4× · PMID 34515393 · DOI 10.1111/dewb.12333