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Trial record 1 of 1 for:    beat19
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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
Sponsor:
Collaborators:
Genetic Alliance
LunaDNA
Cancer Commons
REDCap Cloud
Information provided by (Responsible Party):
xCures

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.


Condition or disease Intervention/treatment
Coronavirus Other: Observation of patients with known, suspected, or at risk for COVID-19 infection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Time to Hospitalization [ Time Frame: Realistic timeframe of 14 days ]
    Time (in days) from onset of symptoms to hospitalization

  2. Time to Symptomatic Recovery [ Time Frame: Realistic timeframe of 14 days ]
    Time (in days) from onset of symptoms to resolution of symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: BEAT19.org (415) 754-9290 info@beat19.org

Locations
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United States, California
BEAT19.org Recruiting
San Francisco, California, United States, 94022
Contact: BEAT19.org       info@beat19.org   
Sponsors and Collaborators
xCures
Genetic Alliance
LunaDNA
Cancer Commons
REDCap Cloud
Investigators
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Principal Investigator: Mark Shapiro xCures
  Study Documents (Full-Text)

Documents provided by xCures:
Additional Information:
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Responsible Party: xCures
ClinicalTrials.gov Identifier: NCT04321811    
Other Study ID Numbers: XC-PCOR-COVID19
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified datasets will be made available to qualified researchers in accordance with the study protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by xCures:
Coronavirus
COVID19
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases