Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection

NCT05195229 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-15

No results posted yet for this study

Summary

The study will be a prospective cohort design to determine if children generate aerosols that harbor a viral load similar to adults. Prior to beginning enrollment, researchers may recruit up to 10 participants (adults or children who meet inclusion criteria for the main study) to perform a small pilot to optimize our cold chain and laboratory procedures.

The study will include children and adults who are confirmed SARS-CoV-2 positive and aim for a total sample size of at least 10 children and 10 adults.

Hypothesis: As children have a high viral load in the nasopharynx, we hypothesize that children generate aerosols that contain SARS-CoV-2 virus.

Aim: To estimate the viral load in aerosols generated from children with COVID-19 infection, and to compare the viral load contained in aerosols from children with aerosols from adults

Conditions

Interventions

DEVICE

COVID-19 Aerosol Collection

Step 1: A nasal and oral swab will be obtained to establish the nasopharyngeal viral load. Step 2: Study staff will use the CCI and/or UPAS to collect aerosol samples for viral load. Staff will sample the room aerosol for 30 minutes while the participant does not wear a mask, and then if the participant is interested, staff will sample room aerosol while the participant wears different types of masks. If the participant does not tolerate wearing a surgical mask, or if the providers believe this is contraindicated, researchers will forego this portion of the study procedures. If an accompanying family member chooses to stay in the patient room during testing, they will be provided with an N95 respirator.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Thomas B Kinane, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2022-03-01
Completion
2022-05-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05195229 on ClinicalTrials.gov