NCT04427358

Brief Summary

Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people. It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease. They investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

November 25, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 10, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

RT-PCR SARS-CoV-2Covid-19CarriageViral shreddingElderlyElderly peopleGeriatric

Outcome Measures

Primary Outcomes (2)

  • 1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection

    at 1 month of COVID infection]

  • 2. Assess quantitative evaluation of a nasopharyngeal swab SARS-CoV-2 RT-PCR test

    The objective of this study is to quantitatively assess viral shedding in COVID-19 infected elderly patients who survived infection in order to provide an overview of the evolution of nasopharyngeal swab SARS-CoV-2 real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test results with the Cycle threshold value of the RT-PCR test.. The investigatrors analyze nasopharyngeal RT-PCR at diagnosis. After one month since the date of onset symptoms they reassessed survival patients with nasopharyngeal RT-PCR and repeat the RT-PCR at least every week until final negative conversion occurs.

    at 1 month after COVID infection

Secondary Outcomes (1)

  • Assessment of late stool SARS-CoV-2 RT-PCR, serological status and associated factors with death and RT-PCR results 1 month after the date of first symptom onset

    1 month after the date of first symptom onset

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient over 70 years age having COVID-19

You may qualify if:

  • Age\> 70years
  • Patient hospitalized on the geriatric center from March 1, 2020 to August 1, 2020 with a diagnosis of COVID-19 still alive at 1 month.
  • Patient having agreed to the re-use of their data for the purposes of this research

You may not qualify if:

  • Subject who expressed his opposition to participate in the study
  • Subject under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service SSR Gériatrique

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 11, 2020

Study Start

May 7, 2020

Primary Completion

August 7, 2020

Study Completion

September 7, 2020

Last Updated

November 25, 2020

Record last verified: 2020-06

Locations