Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Change in symptom severity after COVID-19 infection over 12 months after infection
研究概览
简要总结
This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.
详细描述
This is a prospective observational study being conducted to learn about late (2+ weeks or more) effects of COVID-19 in people living with and without HIV. The investigators plan to do this by studying people who have COVID-19 and people who have not had COVID-19, and by studying people living with HIV and people who are HIV-negative. The investigators will investigate the average duration of symptoms after COVID-19, how these symptoms affect quality of life, and what medical complications are common after COVID-19 in people with and without HIV.
Participation involves:
- Participant completion of surveys about themselves, their health history, their quality of life and mood in the recent past, and about COVID-19 or HIV if the participant has a history of either infection. The investigators will ask participants to answer questions in up to 5 follow-up surveys over the course of a year about their symptoms, mood, quality of life, and changes in health. Participants will also complete a series of short tests of thinking, memory, and reaction speed at certain follow-up surveys.
- Up to two visits to the participant's home (or an acceptable location of their choosing) by a phlebotomist. The phlebotomist will collect about 3.5 tablespoons of blood, as well as measure height, weight, and vital signs when laying down and standing up.
This is a fully remote study and all study activities can be done from home or another location of the participant's choosing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age or older
- •Living within the contiguous 48 states
- •Groups 1 and 3: self-reported HIV infection
- •Groups 2 and 4: self-reported HIV negative
排除标准
- •Inability to communicate by telephone in English or Spanish
- •Inability to complete required study events
- •A first or only diagnosis of COVID-19 5 or more weeks prior to first contact with participant
- •Groups 3 and 4: diagnosis of cOVID-19 ever, or participant suspects they had COVID-19 at any time regardless of whether they were tested
结局指标
主要结局
Change in symptom severity after COVID-19 infection over 12 months after infection
时间窗: 1, 2, 4, 6 and 12 months
Time to return to usual health and activities, as measured using the Influenza Patient-reported Outcome (Flu-PRO) instrument. The overall score is calculated as the mean across 32 items, and ranges from 0 (symptom free) to 4 (very severe symptoms).
Change in fatigue severity
时间窗: 1 and 4 months
Presence/absence of fatigue post-symptom onset, severity of fatigue and its effect on activity level as measured using the Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item tool and each item is ranked from 1 (strongly disagree) to 7 (strongly agree). The item scores are added to generate the overall score, ranging from 9 (least severe) to 63 (most severe).
Change in number of COVID-19 symptoms experienced over 12 months after infection
时间窗: 1, 2, 4, 6 and 12 months
Number of symptoms experienced using Flu-PRO and additional COVID-19 specific symptoms in domains of neuropsychiatry, cardiovascular, and skin. Flu-PRO scores range from 0 (symptom free) to 4 (very severe symptoms).
次要结局
- Change in mMRC rates of dyspnea(1 and 4 months)
- Change in anxiety as assessed using the GAD-7 from month 1 to month 4(1 and 4 months)
- Change in cognitive function (attention and working memory) as assessed through digit span tests from month 1 to month 4(1 and 4 months)
- Change in cognitive function (phonemic and semantic fluency) as assessed through letter and category-guided fluency tests from month 1 to month 4(1 and 4 months)
- Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia(4 months)
- Change in quality of life as assessed using the Short Form-36(1 and 4 months)
- Change in overall mental health as assessed using the CAT-MH from month 1 to month 4(1 and 4 months)
- Change in cognitive function (learning and memory) as measured by the RAVLT from month 1 to month 4(1 and 4 months)
- Change in cognitive function (attention and executive function) as assessed through oral trail tests from month 1 to month 4(1 and 4 months)
- Change in PHQ-9 depression symptoms(1 and 4 months)
- Change in insomnia as assessed using the Insomnia Severity Index from month 1 to month 4(1 and 4 months)