Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff

NCT04408001 | Completed

• 2 other identifiers: 2020-COVID19-042020-A01019-30
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff. A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic. Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool. Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding. The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (6)

• Induced SARS-CoV2 immunity

  The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.

  At day 21 (compared to enrollment [Day 0])

• Long-term protection of induced SARS-CoV2 immunity at 6 months

  The presence of induced immunity will be identified on serology analysis at 6 months.

  6 months following enrollment

• Long-term protection of induced SARS-CoV2 immunity at 1 year

  The presence of induced immunity will be identified on serology analysis at 1 year.

  1 year following enrollment

• Anti-SARS-CoV2 antibodies kinetics in blood throughout the study

  Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement

  From enrollment (Day 0) to 1 year after enrollement

• Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study

  Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement

  From enrollment (Day 0) to 1 year after enrollement

• Kinetics of serum neutralization in blood throughout the study

  Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.

  From enrollment (Day 0) to 1 year after enrollement

Secondary Outcomes (2)

• Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0

  At enrollment (Day 0)

• Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21

  At Day 21

Study Arms (2)

Symptomatic individuals

Hospital staff identified by the COVID-19 case census cell : * who have been infected (confirmed by a positive RT-PCR result on a nasopharyngeal swab) * OR who have displayed clinical signs compatible with COVID-19 despite a negative RT-PCR result.

Other: Clinical interview; Biological: Blood collection; Biological: Saliva collection

Asymptomatic individuals

Hospital staff who have not been identified by the COVID-19 case census cell.

Other: Clinical interview; Biological: Blood collection; Biological: Saliva collection

Interventions

Clinical interview OTHER

At each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19.

Asymptomatic individuals; Symptomatic individuals

Blood collection BIOLOGICAL

At each study visit, * 1 EDTA tube for complete blood count * 3 dry tubes with gel for serology, serum neutralisation test and serum library * 1 cell preparation tube for the separation of immune cells within the circulating blood will be collected.

Asymptomatic individuals; Symptomatic individuals

Saliva collection BIOLOGICAL

At each study visit, a saliva sample will be collected for the determination of IgA antibodies.

Asymptomatic individuals; Symptomatic individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Percy hospital staff having (symptomatic individuals group) or not (asymptomatic individuals group) presented COVID-19 infection symptoms.

You may qualify if:

• years of age or older;
• Military or civilian or contactual volunteer on duty at Percy hospital during the COVID-19 pandemic.

You may not qualify if:

• Individuals who have displayed a severe form of early-onset COVID-19 who required intensive care management or hospitalization;
• Presence of factors modulating immunity with congenital or acquired immunosuppression:
• Medication: cancer chemotherapy, immunosuppressive drugs, biotherapy, corticosteroids
• Uncontrolled HIV infection or CD4 \<200/mm3 infection
• History of solid organ or hematopoietic stem cell transplants

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instuction des Armées Percy

Clamart, 92140, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples ans saliva samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: May 29, 2020
• Study Start: June 4, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (1)