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

NCT05055466 | Completed

• 1 other identifier: INPOSIS
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

SARS-CoV-2 Infection; Covid19; Intestinal Infection

Outcome Measures

Primary Outcomes (1)

• Cytopathic effects and expression of subgenomic mRNA

  Testing for infectious properties of SARS-CoV-2 pathogens detected in clinical specimens including particularly stool (and potentially swabs from the palms, nasopharyngeal swabs including swabs from the oral cavity) will be carried out by using permissive cell lines (VeroE6, CaCo2, or HCT116) under appropriate culture conditions. The readout will be based on the documentation of cell cytopathic effects and expression of subgenomic mRNA using established RTQ-PCR tests.

  A single time point in each patient, upon admission to the hospital

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the hospital for reasons unrelated to COVID-19

You may qualify if:

• Hospitalized pediatric patients: 0-18 years of age
• Informed consent for collection and retention of biomaterial

You may not qualify if:

• Absence of informed consent

Sponsors & Collaborators

• St. Anna Kinderkrebsforschung: lead

Study Sites (4)

St.Anna Children´s Hospital

Vienna, Austria(AUT), 1090, Austria

Location

University Hospital Krems

Krems, Austria

Location

University Hospital Tulln

Tulln, Austria

Location

Klinik Ottakring

Vienna, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples, swabs from the palms, nasopharyngeal swabs including swabs from the oral cavity and biomaterial stored in a biorepository, including stool specimens from paediatric patients who were hospitalized for a variety of indications.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas Lion, Prof, MD, PhD, MSc

  St.Anna Kinderkrebsforschung (CCRI)

  STUDY CHAIR

• Meryl Haas, MSc

  St.Anna Kinderkrebsforschung (CCRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 24, 2021
• Study Start: January 6, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-04

Locations

AU (4)