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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195229
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas B. Kinane, M.D, 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


Condition or disease Intervention/treatment Phase
COVID-19 Device: COVID-19 Aerosol Collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.





Primary Outcome Measures :
  1. Viral Load in Aerosols generated from COVID-19 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195229


Contacts
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Contact: Thomas B Kinane, MD 617-726-7613 kinane.bernard@mgh.harvard.edu
Contact: Peter P Moschovis, MD 617-643-9687 pmoschovis@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Thomas Kinane, MD    617-726-7613    kinane.bernard@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Thomas B Kinane, MD Massachusetts General Hospital
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Responsible Party: Thomas B. Kinane, M.D, MD Pediatric Medical Services (MGHfC), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05195229    
Other Study ID Numbers: 2020P002886
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas B. Kinane, M.D, Massachusetts General Hospital:
COVID-19
Viral Load
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases