search
Back to results

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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 Aerosol Collection
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring COVID-19, Viral Load

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
January 31, 2022
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05195229
Brief Title
Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection
Official Title
Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Viral Load

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
COVID-19 Aerosol Collection
Intervention Description
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 Information:
Title
Viral Load in Aerosols generated from COVID-19
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas B Kinane, MD
Phone
617-726-7613
Email
kinane.bernard@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Peter P Moschovis, MD
Phone
617-643-9687
Email
pmoschovis@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Kinane, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Kinane, MD
Phone
617-726-7613
Email
kinane.bernard@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs