Behavior, Environment And Treatments for Covid-19 (BEAT19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04321811|
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 2, 2020
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.
|Condition or disease||Intervention/treatment|
|Coronavirus||Other: Observation of patients with known, suspected, or at risk for COVID-19 infection|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)|
|Actual Study Start Date :||March 21, 2020|
|Estimated Primary Completion Date :||March 20, 2021|
|Estimated Study Completion Date :||March 20, 2022|
Adult men and women currently in the United States and willing to provide written informed consent and:
Other: Observation of patients with known, suspected, or at risk for COVID-19 infection
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.
- Define Natural Symptom Course [ Time Frame: Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days) ]
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.
- Time to Hospitalization [ Time Frame: Realistic timeframe of 14 days ]Time (in days) from onset of symptoms to hospitalization
- Time to Symptomatic Recovery [ Time Frame: Realistic timeframe of 14 days ]Time (in days) from onset of symptoms to resolution of symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321811
|Contact: BEAT19.org||(415) email@example.com|
|United States, California|
|San Francisco, California, United States, 94022|
|Contact: BEAT19.org firstname.lastname@example.org|
|Principal Investigator:||Mark Shapiro||xCures|