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COVID-19 Active Research Experience (CARE)

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ClinicalTrials.gov Identifier: NCT04368065
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Iqvia Pty Ltd

Study Description
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Brief Summary:
COVID-19 Active Research Experience (CARE) is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness or who were vaccinated against COVID-19 to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness.

Condition or disease
COVID-19

Detailed Description:
This is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness. Upon consent and enrollment, participants will complete an initial baseline survey reporting their demographics, relevant medical history, testing, vaccination, symptoms, use of prescription medications as well as use of supplements and other factors. The study follow-up period is 12 months. During the first month of follow-up participants will be invited to complete a symptom diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-pharmaceutical interventions as well as healthcare encounters. Reporting will then reduce to monthly for Month 2 through 12.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Registry to Study Factors That May Impact COVID-19 Occurrence and Severity
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 symptom occurrence and severity [ Time Frame: 12 months ]
    Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey

  2. COVID-19 treatments [ Time Frame: 12 months ]
    Prescription treatments for COVID-19 as reported by participants in the survey

  3. COVID-19 risk factors [ Time Frame: 12 months ]
    Assess potential role of comorbidities and concomitant medications on COVID-19 occurrence and severity

  4. Occurrence and severity of COVID-19 infection after vaccination [ Time Frame: 12 months ]
    Occurrence and severity of COVID-19 infection as reported by participants after SARS-CoV-2 vaccine

  5. Occurrence of medically attended events after vaccination [ Time Frame: 1 month ]
    Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine


Eligibility Criteria
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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 living in the US or UK who have COVID-19 or COVID-19 like symptoms, were vaccinated against COVID-19, or were exposed to COVID-19.
Criteria

Inclusion Criteria:

  • Adult (18 years or older)
  • Currently living in the US or UK
  • Have regular access to a computer, smartphone or tablet and sufficient internet to support registry demands (note: this registry is designed to operate well even in regions with low bandwidth)
  • Willing and able to provide informed consent
  • Willing and able to follow the procedures of the study

Participants must also meet at least one of the following conditions:

  • Have COVID-19 or COVID-19 like symptoms
  • Received a COVID-19 vaccine
  • Potential exposure to COVID-19

Exclusion Criteria:

  • Unable to provide informed consent
  • Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks
Contacts and Locations
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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): NCT04368065


Contacts
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Contact: Tom Kwon +1 917 328 4635 tkwon@us.imshealth.com

Locations
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United States, Massachusetts
IQVIA Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Nancy Dreyer       CAREproject@iqvia.com   
Principal Investigator: Nancy Dreyer, PhD, MPH         
United Kingdom
IQVIA Recruiting
London, United Kingdom
Contact: Nancy Dreyer       CAREproject@iqvia.com   
Sponsors and Collaborators
Iqvia Pty Ltd
Investigators
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Principal Investigator: Nancy Dreyer, PhD, MPH Iqvia Pty Ltd
  Study Documents (Full-Text)

Documents provided by Iqvia Pty Ltd:
Study Protocol  [PDF] March 9, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Iqvia Pty Ltd
ClinicalTrials.gov Identifier: NCT04368065    
Other Study ID Numbers: IQVIA_COVIDREGISTRY_2020
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is anticipated that external researchers may want to leverage these data for public health and life sciences research. The intent is to provide limited data access to qualified researchers for research that has gone through a review process.
Supporting Materials: Study Protocol
Time Frame: Data will be available during conduct of the study and two years following study completion.
Access Criteria: Qualified researchers that have undergone a review process may submit requests to the IQVIA Registry Data Governance Committee (DGC) requesting approval and access for specific research purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases