Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,590
- 试验地点
- 1
- 主要终点
- Screening Phase
研究概览
简要总结
Background:
People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 in different ways. In this study, researchers will use survey data to describe the different ways people experience and recover from COVID-19. They will also use the data to help create future studies to understand why some people do not fully recover.
Objective:
To learn more about the range and timing of symptoms that people have before, during, and after COVID-19 infection.
Eligibility:
People ages 18 and older who can give documentation of a positive COVID-19 or antibody test.
Design:
Participants will be screened with a telephone interview. It will take 15 minutes. They will provide their COVID-19 test results and medical records.
Participants will complete a second telephone interview. It will take 30 60 minutes. They will also take online surveys every 3 months for 3 years.
The interview and surveys will ask participants about their health before they got COVID-19, what happened while they had COVID-19, and what their recovery has been like.
Participants will get log-in data to take the online surveys. Completing all of the surveys the first time may take up to 3 hours. Follow-up surveys will take up to 30 minutes. Participants do not have to complete the surveys in one sitting. They will be able to save their progress and finish the surveys later.
Participants may be contacted to take part in other research studies.
详细描述
Study Description:
In late 2019, the novel coronavirus SARS/CoV2 appeared in Wuhan, China. The various ways that humans will recover from COVID-19 is just starting to be observed and it is clear there will be a wide range of convalescent experiences. A year into the pandemic, the post-acute sequelae of SARS/CoV2 infection (PASC) is known to be common and includes a broad range of symptoms and potential pathologies. This phased protocol is designed to observe and study the convalescence and recoveries from acute SARS/CoV2 infections.
Phase A Phase A Surveying (Phase A) will enable people in the community that are convalescing from COVID-19 to be studied using telephone interviews and internet-based questionnaires. The objective of Phase A Surveying is to observe and describe the range of medical syndromes that occur in the wake of an acute SARS/CoV2 infection.
Participants are required to be within the first five years of their recovery and have documentation of a positive laboratory test for COVID-19. Additional cohorts of persons with neurological sequelae, persons with a clinical diagnosis of COVID-19 with negative testing, persons with adverse complications after COVID 19 vaccination and participants co-enrolled in other research studies within the Division of Intramural Research will also be studied. The data collected during Phase A will describe the range of symptoms and patterns of symptom clustering of PASC. This data will also characterize the patient populations which have been or will be evaluated at the NIH Clinical Center in more detail.
Phase B Evaluation (Phase B) will allow surveyed participants of research interest from Phase A to be invited to the NIH Clinical Center for a medical evaluation and to undergo a panel of standard research measurements. Each participant will be medically and psychologically characterized to best understand if their complaints can be attributed to known disorders. The observations made during Phase B will provide insights into the range, character, and subtypes of PASC. Individuals found to have disorders being studied within the Division of Intermural Research at NIH will be appropriately referred.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •For Phase A Surveying:
- •1590 persons who are recovering or have recovered from an acute SARS/CoV2 infection will participate.
- •Inclusion criteria for Phase A:
- •Post-COVID-19 Convalescence (n=890)
- •Participants 18 and older
- •Ability to provide informed consent
- •Stated willingness to complete telephone interviews
- •4 Reports having begun recovery from an acute SARS/CoV2 infection in the past 5 years
- •a.For participants who don t have a known recovery date, a date of 6 weeks from infection will be imposed
- •5 Provides documentation of a positive COVID-19 Test. Approved test can include the following:
- •PCR, NAA, or other EUA Approved test to confirm active COVID infection.
- •A positive home Antigen test is acceptable when documentation of a photograph of the test with a phone-based date and time stamp is provided.
- •A positive anti-Spike antibody test is accepted in unvaccinated individuals or those who had antibody testing prior to vaccination.
- •A positive anti-nucleocapsid antibody test
- •Test-Negative COVID-19 with Persistent Symptoms (n=50)
- •Participants 18 and older
- •Ability to provide informed consent
- •Stated willingness to complete telephone interviews
- •Reports having developed persistent symptoms as a consequence of an acute SARS/CoV2 infection
- •Provides documentation of a clinical diagnosis of an acute SARS/CoV2 infection from a medical practitioner OR meets the Clinical Criteria of the 2020 CDC Interim Case Definition for Probable SARS/CoV2 infection.
- •Has either negative or absent COVID-19 PCR, NAA, or other EUA Approved testing for the documented SARS/COV2 infection.
- •Provides documentation of a negative COVID-19 antibody test prior to vaccination.
- •COVID-19 vaccine related medical conditions (n=50)
- •Participants 18 and older
- •Ability to provide informed consent
- •Stated willingness to complete telephone interviews
- •Reports having developed persistent symptoms as a consequence of a COVID 19 vaccination
- •Provides documentation of COVID-19 vaccination
- •Provides documentation of a COVID-19 vaccine related medical condition from a medical practitioner
- •Participants with a history of multiple SARS-CoV-2 infections (N=600)
- •Participants 18 and older
- •Ability to provide informed consent
- •Stated willingness to complete telephone interviews
- •Reports having more than one SARS-CoV-2 infection
- •Provides documentation of at least one positive COVID-19 Test. Approved test can include the following:
- •PCR, NAA, or other EUA Approved test to confirm active COVID infection.
- •A positive home Antigen test is acceptable when documentation of a photograph of the test with a phone-based date and time stamp is provided.
- •A positive anti-Spike antibody test is accepted in unvaccinated individuals or those who had antibody testing prior to vaccination.
- •A positive anti-nucleocapsid antibody test
- •The elements of the 2020 CDC Interim Case Definition for Probable COVID-19 used for this protocol will be the Clinical Criteria:
- •Clinical Criteria:
- •At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s)
- •At least one of the following symptoms: cough, shortness of breath, or difficulty breathing
- •Severe respiratory illness with at least one of the following:
- •Clinical or radiographic evidence of pneumonia, OR
- •Acute respiratory distress syndrome (ARDS).
- •No alternative more likely diagnosis
- •For Phase B Evaluation:
- •240 persons who are recovering or have recovered from COVID-19 within the last five years will participate. The accrual ceiling is 120 PASC and 120 healthy volunteers, with a goal to identify 80 PASC participants and 80 post-COVID fully recovered healthy volunteers who may be eligible for Phase C. Time since infection (i.e. within first six months, six months to one year, one year to two years, and two years to five years) will also be considered, with a goal of recruiting at least 20 PASC participants and 20 post- COVID fully recovered participants within each of these four time frames.
- 另有 52 项未显示
排除标准
- •for Mild to Moderate Illness COVID-19 with severe post-acute COVID-19 symptoms after completing Phase B.
- •No alternative explanation for PASC symptoms identified by adjudication committee during Phase B.
- •Fluency in English
- •Inclusion Criteria for Mild or Moderate Illness COVID-19 without PASC symptoms:
- •Met inclusion and exclusion criteria for Mild to Moderate Illness COVID-19 without post-acute COVID-19 symptoms after completing Phase B.
- •Fluency in English
- •EXCLUSION CRITERIA:
- •Exclusion criteria for Phase A:
- •Not willing to provide personal identifying information to investigative team
- •Cognitive impairment that is severe enough to limit consent capacity
- •Exclusion criteria for Phase B Evaluation:
- •Information collected from Phase A interviews, review of medical records, and discussions with consented Phase A participants will be used to determine if a participant will be excluded from participation.
- •Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
- •Major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
- •Current or past substance use disorder within last five years. Marijuana use within the past five years will not be an exclusion.
- •Positive urine toxicology screening for anything other than marijuana. Positive result for corresponding medication prescribed for short-term medical issue may be allowed after investigator review. Examples include use of a benzodiazepine prior to air travel to NIH or narcotic medication related to a recent medical procedure or injury.
- •Current suicidal ideation
- •History of head injury leading to moderate or severe traumatic brain injury. Persons having a history of mild TBI (mTBI) will not be excluded.
- •Women who are pregnant, breastfeeding, or are within one-year post-partum.
- •Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
- •Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.
- •Current or previous long-term immune suppressive therapy. Recent or current steroid use for the treatment of COVID-19, PASC, recent allergic reactions, and topical steroid use is allowed.
- •Any premorbid medical condition that would potentially cause fatigue and exercise intolerance that would exclude from participation in Phase C. This includes many chronic medical diseases, such
- •as congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe arthritis, uncontrolled asthma, renal failure, fibromyalgia, and ME/CFS.
- •Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
- •Not willing to allow for research data and samples to be shared broadly with other researchers.
- •Employees at NIH that are under the direct supervision of the study investigators (family members of NIH employees are permitted to participate).
- •Symptom severity that makes it impossible for the volunteer to travel to NIH.
- •Exclusion criteria for Phase C Deep Phenotyping:
- •Exclusion criteria for all Phase C participants:
- •Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
- •Current DSM-5-defined major depression disorder, generalized anxiety disorder, post-traumatic stress disorder,...
研究组 & 干预措施
Post COVID patients
Individuals whom have previously had COVID -19 infection.
结局指标
主要结局
Screening Phase
时间窗: End of Study
The number and severity of persistent symptoms associated with COVID-19 convalescence. Collected data will be used to characterize different narratives of COVID-19 convalescence.
Phase C: Deep Phenotyping
时间窗: End of Study
Phase C: Immune system and inflammatory signaling characterization in at baseline and following maximal exercise exertion using flow cytometry, RNA sequencing, multiplex immunochemical analysis, NK cell functional analysis. Microbiome characterization at baseline and following maximal exercise exertion using shotgun metagenomics. Bioenergetics, autonomic, and metabolic characterization using mitochondrial plasmid genotyping, pulmonary spirometry, gas exchange measurements during exercise, metabolic chamber measurements of total body energy use, metabolomic analysis of stool, mitochondrion proteomics and metabolomics from muscle, and functional respiration of PBMCs using extracellular flux mito stress assay.
Phase B: Evaluation
时间窗: End of Study
Phase B: Standard clinical and research evaluations will be used to measure cardiopulmonary, neurological, and functional status and identify individuals with unknown PASC.
次要结局
未报告次要终点