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Behavior, Environment And Treatments for Covid-19

NCT04321811 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2022-07-14

No results posted yet for this study

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.

Conditions

  • Coronavirus

Interventions

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.

Sponsors & Collaborators

  • Genetic Alliance

    collaborator OTHER

  • LunaDNA

    collaborator UNKNOWN

  • Cancer Commons

    collaborator OTHER

  • REDCap Cloud

    collaborator UNKNOWN

  • xCures

    lead INDUSTRY

Principal Investigators

  • Mark Shapiro · xCures

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-21
Primary Completion
2021-02-09
Completion
2021-03-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321811 on ClinicalTrials.gov