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

NCT05195229 | Unknown

• 1 other identifier: 2020P002886
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

COVID-19; Viral Load

Outcome Measures

Primary Outcomes (1)

• Viral Load in Aerosols generated from COVID-19

  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.

  10 days

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Device: COVID-19 Aerosol Collection

Interventions

COVID-19 Aerosol Collection DEVICE

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.

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

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 B Kinane, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas B Kinane, MD

CONTACT

617-726-7613; kinane.bernard@mgh.harvard.edu

Peter P Moschovis, MD

CONTACT

617-643-9687; pmoschovis@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Pediatric Medical Services (MGHfC)

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 18, 2022
• Study Start: January 13, 2022
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)