Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Viral Load in Aerosols generated from COVID-19
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: COVID-19 Aerosol Collection (Device)
结局指标
主要结局
Viral Load in Aerosols generated from COVID-19
时间窗: 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.
次要结局
未报告次要终点
研究者
Thomas B. Kinane, M.D
MD Pediatric Medical Services (MGHfC)
Massachusetts General Hospital