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

Covid-19 Clinical Trial

— COVID-19GAOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427358
• Other study ID #: 7838
• Status: Completed
• Start date: May 7, 2020
• Est. completion date: September 7, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 7, 2020
• Est. primary completion date: August 7, 2020
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Infection

Locations

Country	Name	City	State
France	Service SSR Gériatrique	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection		at 1 month of COVID infection]
Primary	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	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	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	1 month after the date of first symptom onset