Behavior, Environment And Treatments for Covid-19
BEAT19
A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)
1 other identifier
observational
5,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2020
CompletedFirst Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2021
CompletedJuly 14, 2022
July 1, 2022
11 months
March 23, 2020
July 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Time to Hospitalization
Realistic timeframe of 14 days
Time to Symptomatic Recovery
Realistic timeframe of 14 days
Study Arms (1)
Participants
Adult men and women currently in the United States and willing to provide written informed consent and: * who are feeling sick but have not tested positive for COVID-19 * who are feeling sick and have tested positive for COVID-19 * People who are not feeling sick but want to participate
Interventions
Participants will receive daily diary surveys to track the symptomatic course of known or suspected COVID-19 patients as well as use of any interventions or treatments.
Eligibility Criteria
Adults currently in the United States who may be infected or are at risk of infection with novel cornoavirus SARS-CoV-2 during the current pandemic.
You may qualify if:
- 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
You may not qualify if:
- People who are unwilling or unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- xCureslead
- Genetic Alliancecollaborator
- LunaDNAcollaborator
- Cancer Commonscollaborator
- REDCap Cloudcollaborator
Study Sites (1)
BEAT19.org
San Francisco, California, 94022, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Shapiro
xCures
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
March 21, 2020
Primary Completion
February 9, 2021
Study Completion
March 20, 2021
Last Updated
July 14, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
De-identified datasets will be made available to qualified researchers in accordance with the study protocol.