Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05195229

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

COVID-19 Aerosol Collection

Study Details

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

Study ID

NCT05195229

Start date

Jan 13, 2022

Status verified date

Jan, 2022

Completion date

May 1, 2022

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm 1

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

Interventions

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.

Primary outcome measure

  • Viral Load in Aerosols generated from COVID-19 [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Thomas B Kinane, MD

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

Peter P Moschovis, MD

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Thomas Kinane, MD

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 15, 2022

Last verified

Jan, 2022

Keywords

  • COVID-19
  • Viral Load

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-02-15.