Coronavirus Clinical Trial
— BEAT19Official title:
A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)
Verified date | July 2022 |
Source | xCures |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Background: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community. Objectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.
Status | Completed |
Enrollment | 5000 |
Est. completion date | March 20, 2021 |
Est. primary completion date | February 9, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People who are feeling sick and have tested positive for COVID-19 - People who are feeling sick but have not tested positive for COVID-19 - People who are not feeling sick but want to participate Exclusion Criteria: • People who are unwilling or unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | BEAT19.org | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
xCures | Cancer Commons, Genetic Alliance, LunaDNA, REDCap Cloud |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Define Natural Symptom Course | Daily survey of symptoms known or reported to be associated with COVID-19 infection based including:
Headache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe. |
Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days) | |
Secondary | Time to Hospitalization | Time (in days) from onset of symptoms to hospitalization | Realistic timeframe of 14 days | |
Secondary | Time to Symptomatic Recovery | Time (in days) from onset of symptoms to resolution of symptoms | Realistic timeframe of 14 days |
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