Immune Responses to COVID-19; Isolation of Neutralizing Antibodies for Therapeutics and Vaccine.

NCT04596098 | Completed DMC

• 2 other identifiers: 38RC20.1322020-A00904-35
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

According to different projections, the COVID-19 outbreak currently happening in France and worldwide could result in millions of deaths in the absence of efficient therapies. The COVID-19 causative agent, the SARS-CoV-2, is a virus leading to respiratory system infections in human and for which there is currently no vaccine or treatment scientifically validated in clinical studies. In that context, therapeutic human neutralizing antibodies targeting the SARS-CoV-2 envelop glycoproteins and which enable inhibition of the viral replication represent an innovative therapeutic alternative with great potential. These antibodies are also critical tools for vaccine development. Simultaneously, CHUGA researchers coordinate with each other to set up a collective biological collection to achieve others objectives such as biomarkers identifications.

Conditions

SARS-CoV 2

Keywords

Coronavirus Infection; Neutralizing monoclonal antibodies; antibodies/development; biomarkers/blood; biomarkers/immunology; SARS-CoV 2

Outcome Measures

Primary Outcomes (2)

• Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes.

  Step 1 : Measurement of the monoclonal antibody concentration inhibiting 50% of the target cells infection (IC 50%) via a VSV virus pseudotyped with SARS-CoV-2 envelope glycoproteins. Neutralizing activity is defined with an IC 50 below 50 ug/ml.

  From all blood sampling with serum (visit 1 at Day1, visit 6 at Day13 or, in b-group, visit 9 occuring between month 2 and month 6).

• Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes.

  STEP 2 : Ability to produce monoclonal recombinant antibodies anti-SARS-CoV-2 from memory B cell (fundamental outcome : yes/no)

  From patient and time frame identified in step 1 described above.

Secondary Outcomes (8)

• Description of biological biomarkers (cytokine, IL6) predictive of worsening

  day 1

• Description of biological biomarkers (cytokine, IL10) predictive of worsening

  day 1

• Description of biological biomarkers (Cellular immune responses, lymphocytes) predictive of worsening

  day 1

• Description of biological biomarkers (Cellular immune responses, monocytes) predictive of worsening

  day 1

• Description of biological biomarkers (complement system, CH50) predictive of worsening

  day 1

Study Arms (2)

Group A

Patient hospitalized in Grenoble University Hospital for CoViD19. Patient not previously followed in Grenoble University Hospital for a chronic disease.

Other: Blood sampling

Group B

Patient hospitalized in Grenoble University Hospital for CoViD19. Patient followed in Grenoble University Hospital for a chronic disease.

Other: Blood sampling

Interventions

Blood sampling OTHER

During a care-related blood sampling, patient will provide additional blood sample for research purpuse.

Also known as: Biological collection

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Grenoble University hospital for a COVID-19 infection for less than 48 hours (who is not already included in a study and consent to AcNT study).

You may qualify if:

• Man or woman over 18 years old hospitalized in Grenoble University hospital for a COVID-19 infection for less than 48 hours,
• Symptomatic patient with an estimated hospitalization period over 7 days and requiring regular blood sampling,
• Patient weighing more than 60 kg.
• Patient who has given his non-opposition/consent for AcNT study.
• Patient affiliated toFrench Social Security System.

You may not qualify if:

• Patient non able to consent (such as intubated patient in ICU)
• Patient protected by the French law (defined as: minor, pregnant or breastfeeding woman, patient under curatorship, patient deprived of liberty or hospitalized against his/her will)
• Patient already included in a clinical trial involving substantial blood sampling (over 20mL a day or over 150mL a month).
• Patient whose medical condition is not compatible with the trial (impossibility to consent, intensive case unit, anaemia with haemoglobin under 10g/dl… )

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator

Study Sites (1)

UniversityGrenobleHospital

Grenoble, 38043, France

Location

Related Publications (17)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood : serum, plasma, PBMC (Peripheral blood mononuclear cell )

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pascal POIGNARD, PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: October 22, 2020
• Study Start: April 30, 2020
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

FR (1)