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Completed

NCT Number: NCT04427358

RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population

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

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service SSR Gériatrique

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: at 1 month of COVID infection]

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

    Time frame: at 1 month after COVID infection

    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.

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

    Time frame: 1 month after the date of first symptom onset

    • Assessment of late stool SARS-CoV-2 RT-PCR results one month after the date of onset symptom(dso) (% of patients with a positive fecal RT-PCR test after 1 month)
    • COVID-19 serological status; associated factors with death and RT-PCR results 1 month after the dso: Age (year), gender, Medical history prior to hospilization : Hypertension, diabetes, coronary artery disease, heart failure, atrial fibrillation, chronic respiratory disease, History of medication: ACEI, ARBs Antiplatetet drug, doses of anticoagulant therapy, antibiotic, corticotherapy, statin, Proton pump inhibitor, T°C>37.8 7 days after the onset of symptoms, weight in kg, height in meter combined to report BMI in kg/m^2, Charlson score, Use of adjuvant oxygen, Lung CT-Scan results : extent of lesion <25%/25-50%/50-75%/>75%, Lymphocytes, platelet, CRP count at the time of diagnosis and 7 days after, GFR at diagnosis ml/min /1.73m2, ABO group, Rhesus antibody, Nasopharyngeal RT PCR initial Cycle Threshold

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: COVID-19GAOM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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