NCT05055466: INPOSIS

COVID-19: Infectious Potential of SARS-CoV-2 Intestinal Shedding in Pediatric Patients (INPOSIS)

Completed Last updated 9 December 2024

What this trial tests

trial in SARS-CoV-2 Infection in 283 participants. Completed in 30 September 2023.

Timeline

6 January 2021

Primary endpoint
31 March 2022

30 September 2023

Quick facts

Lead sponsor	St. Anna Kinderkrebsforschung
Status	Completed
Study type	OBSERVATIONAL
Enrollment	283
Start date	6 January 2021
Primary completion	31 March 2022
Estimated completion	30 September 2023
Sites	4 locations across Austria

Conditions studied

• SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →
• Covid19 — all drugs for Covid19 →
• Intestinal Infection — all drugs for Intestinal Infection →

Sponsor

St. Anna Kinderkrebsforschung — full company profile →

Who can join

Under 18, any sex, with SARS-CoV-2 Infection or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The clinical courses of COVID-19 in children are reportedly mild, and may therefore readily escape diagnosis. Prolonged intestinal virus shedding has been reported in children, thus rendering the pediatric population a potentially important source of virus transmission. However, the infectious potential of SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) excreted in the stool has remained enigmatic.

The investigators hypothesize that stools carrying the virus can represent a source of infection, at least in a proportion of instances, and therefore intend to screen stools of children admitted to the hospital regardless of the indication in order to assess the frequency of intestinal virus excretion. The screening will be performed by validated RTQ-PCR (reverse transcription quantitative polymerase chain reaction) assays. In positive cases, stool extracts will be used to inoculate permissive cells (e.g. VeroE6) under BSL3 (Biosafety Level 3) conditions, and the infectious potential of the viruses will be determined. The readout will be based on the assessment of cell cytopathic effects and on the expression of subgenomic mRNA. it is expected to recruit \~100 patients for the study.

Additionally, the investigators will specifically examine children admitted to the hospital because of COVID-19, and will determine the temporal correlation between viral loads in the upper respiratory tract (URT) and serial stool specimens as well as swabs from the palms and from the oral cavity using RTQ-PCR. Longitudinal studies on the infectious potential of viruses from the URT and stool will be performed using the experimental approach outlined above. For this part of the study, is is intended to recruit \~100 children.

Furthermore, samples derived from \>200 patients from our biorepository will be used.

The insights gained from the study will greatly expand the knowledge on the epidemiological and clinical significance of SARS-CoV-2 infections in children. If stools are identified as a potential source of infection, the data will have an important impact on safety measures in specific settings such as the kindergarten.

Publications & conference data

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

1. Intestinal Shedding of SARS-CoV-2 in Children: No Evidence for Infectious Potential.
   Nogueira F, Obrova K, Haas M, Tucek E, et al · · 2022 · cited 2× · PMID 36677323 · DOI 10.3390/microorganisms11010033