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

Not Applicable

• Conditions: COVID-19
• Interventions: Device: COVID-19 Aerosol Collection

• Registration Number: NCT05195229
• Lead Sponsor: Massachusetts General Hospital

Brief 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

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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-13
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-18
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	COVID-19 Aerosol Collection	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

Primary Outcome Measures

Name	Time	Method
Viral Load in Aerosols generated from COVID-19	10 days	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. Measures will be extracted to assess if the cycle threshold value is high enough in aerosols for virus to be transmitted to others.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States