Post copied from Attitudes of incoming US politicians to ME/CFS and post-Covid 19 illness Details below. Basically, they aim to recruit a lot of people with a positive diagnosis for SARS-COV2 and follow them for 18 months, with ME/CFS as the primary outcome. (I think that's quite a strong connection with ME/CFS.) Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) Sponsors Lead Sponsor: Rush University Medical Center Collaborator: Yale University University of Washington Thomas Jefferson University University of California, Los Angeles University of California, San Francisco University of Texas Southwestern Medical Center The University of Texas Health Science Center, Houston Source Rush University Medical Center Brief Summary This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protects individual privacy but promotes rapid dissemination and implementation of knowledge. Overall Status Not yet recruiting Start Date November 14, 2020 Completion Date November 14, 2022 Primary Completion Date November 14, 2022 Study Type Observational [Patient Registry] >> Primary Outcome Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) 18 months post enrollment<< Secondary Outcome Measure Time Frame Ambulatory care and/or ED visits post enrollment 18 months post enrollment Hospitalizations post enrollment 18 months post enrollment Death during hospital admission 18 months post enrollment Hospital-free survival 18 months post enrollment ICU-free survival 18 months post enrollment Enrollment 4800 Condition Covid19 ME/CFS SARS COV2 Novel Coronavirus Infection Neurocognitive Disorders Cardiovascular Diseases Eligibility Sampling Method: Non-Probability Sample Criteria: INCLUSION CRITERIA 1. Fluent in English or Spanish; 2. Age 18 and over; 3. Self-reported symptoms suggestive of acute SARSCOV2 infection; 4. Under investigation for SARSCOV2 (defined as a patient who has received any screening or diagnostic test used to detect the presence of COVID19 including any FDA approved or authorized molecular or antigen-based assay) within the last 28 days. EXCLUSION CRITERIA 1. Unable to provide informed consent; 2. Study team unable to confirm result of diagnostic test for SARSCOV2; 3. Does not have access to a hand-held device or computer that would allow for digital participation in the study; 4. Individuals who are prisoners while participating in the study.
I think studies like this could prove important in terms of looking at likelihoods of getting ME (or other complications) and then a good follow up. I assume they have a good random sample. Although a longer follow up than 18 months would be good. I wonder if different diseases have different potential trigger rates.
18 month follow will not be long enough having read many reports of people who feel they are back to normal only to have major relapses two or even five years later . human beings have a natural tendency to overlook their own health issues i successfully deluded my self for a decade regarding cognitive issues around memory and facial recognition . so from that point of view a minimum of five years follow up would be more likely to retrieve the right results .
I wonder what they will do after 18 months if their findings are interesting. Will it just go in the wastebasket with all the other interesting findings?
It looks like the incidence of ME/CFS is a secondary outcome now (instead of primary): https://ichgcp.net/clinical-trials-registry/NCT04610515 Primary Outcome Measure Time Frame Assess for medium and long-term sequalae of SARS-CoV-2 infection 18 months post enrollment Secondary Outcome Measure Time Frame Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) 18 months post enrollment Ambulatory care and/or ED visits post enrollment 18 months post enrollment Hospitalizations post enrollment 18 months post enrollment Death during hospital admission 18 months post enrollment Hospital-free survival 18 months post enrollment ICU-free survival 18 months post enrollment ---- Also: Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): a longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection ABSTRACT BACKGROUND Reports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection. METHODS INSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Included are adults fluent in English or Spanish, with self-reported symptoms suggestive of acute SARS-CoV-2 infection, enrolled within 42 days of having a US Food and Drug Administration approved SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test). Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants will be followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our maximum expected enrollment is 4,800 participants, including 3,600 SARS-CoV-2 positive and 1,200 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses. RESULTS Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing. CONCLUSIONS This study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection. Open access to the full version: https://www.medrxiv.org/content/10.1101/2021.08.01.21261397v1.full-text