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NCT04321811 · ClinicalTrials.gov registry record
Behavior, Environment And Treatments for Covid-19
A clinical trial, sponsored by xCures.
- Completed
- Registry status
- 5,000
- Enrollment target
NCT04321811: Completed study, sponsored by xCures.
NCT04321811 is a clinical trial that has completed, run by xCures. The registered enrollment target is 5,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04321811 has completed, sponsored by xCures.
- COMPLETED
- Registry status
- 5,000 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Observation of patients with known, suspected, or at risk for COVID-19 infection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2020-03-21 |
| Est. Completion | 2021-03-20 |
What the finished NCT04321811 record still lists
NCT04321811 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Observation of patients with known, suspected, or at risk for COVID-19 infection is the first listed.
NCT04321811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04321811 about?
NCT04321811 is a clinical study titled "Behavior, Environment And Treatments for Covid-19". 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,...
What is the current status of trial NCT04321811?
This trial is currently completed. The enrollment target is 5,000 participants. The study started on 2020-03-21. Estimated completion is 2021-03-20.
What interventions are being tested in trial NCT04321811?
The interventions under investigation include: Observation of patients with known, suspected, or at risk for COVID-19 infection (OTHER).
Who is sponsoring clinical trial NCT04321811?
This trial is sponsored by xCures, which has 4 total clinical trials registered on ClinicalTrials.gov.
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