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

The study will be a prospective cohort design to determine if children generate aerosolsthat harbor a viral load similar to adults. Prior to beginning enrollment, researchersmay recruit up to 10 participants (adults or children who meet inclusion criteria for themain study) to perform a small pilot to optimize our cold chain and laboratoryprocedures.The study will include children and adults who are confirmed SARS-CoV-2 positive and aimfor 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 thatchildren generate aerosols that contain SARS-CoV-2 virus.Aim: To estimate the viral load in aerosols generated from children with COVID-19infection, and to compare the viral load contained in aerosols from children withaerosols from adults

Detailed Description

For children and adults who are admitted to MGH, study staff will perform:

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.

Step 3: Staff will ask participants to repeat these steps and provide a sample each day
that they are having symptoms of COVID-19. The study may conduct serial sampling, where
participants could be asked to provide a sample each day that they are having symptoms of
COVID-19 up until discharge, or once symptoms resolve. Once symptoms resolve or the
patient is discharged, sampling will be complete.

Unknown status
COVID-19

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.

Eligibility Criteria

Inclusion criteria:

- SARS-CoV-2 PCR positive in the last fourteen days

- Symptomatic with typical symptoms of COVID-19, including fever, cough, nasal
congestion, rhinorrhea, anosmia, ageusia, shortness of breath, chest pain, fatigue,
myalgias, or other atypical symptoms with documentation of that symptom OR

- Asymptomatic with laboratory confirmation of cycle threshold value < 30.

Exclusion criteria:

- Chronic respiratory disease or neuromuscular condition associated with severely
reduced lung function defined as FEV1 or FVC <50% predicted, or requiring chronic
supplemental oxygen or respiratory support

- On current respiratory support via supplemental oxygen, non-invasive ventilation, or
invasive mechanical ventilation

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Massachusetts General Hospital
Boston, Massachusetts, United States

Investigator: Thomas Kinane, MD
Contact: 617-726-7613
kinane.bernard@mgh.harvard.edu

Contacts

Thomas B Kinane, MD
617-726-7613
kinane.bernard@mgh.harvard.edu

Peter P Moschovis, MD
617-643-9687
pmoschovis@mgh.harvard.edu

Thomas B Kinane, MD, Principal Investigator
Massachusetts General Hospital

Massachusetts General Hospital
NCT Number
Keywords
Covid-19
Viral load
MeSH Terms
COVID-19