COVIDANTI-COV-2NCT04354766
COVID-19 : Neutralizing Human Monoclonal Antibodies Against SARS-Cov-2
An observational study of COVID, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Blood sample
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2020to 18 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study relates to 10 adult subjects who were infected with SARS-Cov-2 (positivity confirmed by PCR test), who were symptomatic, and who were in the recovery phase when the blood sample was collected. Among the 10 convalescent subjects who will be sampled, we will select two distinct populations: (i) five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform which was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization was not required; (ii) five convalescent patients (minimum 12 days after the onset of symptoms), hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxemic pneumonia requiring hospitalization.
Who may be able to join
- Patient over 18 years old
- Patient who signed the study consent form
- Convalescent patient (at least 12 days after the onset of symptoms), having been sampled at Hospices Civils de Lyon for a suspected infection with SARS-Cov-2, confirmed by PCR.
Who cannot join
- Patient treated with rituximab
- Patient treated with immunoglobulins
- Patient over 18 years old, subject to a legal protection measure (guardianship or trusteeship)
- Patient deprived of liberty
- Pregnant or lactating woman
- Patient not affiliated to a social security scheme or beneficiary of a similar scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.
The objectives of this study are :
- To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
- To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
- To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.
- Conditions
- COVID
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
This study will require a blood sample (4 ACD tubes, 20 ml) at one time.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent patients diagnosed with COVID + | Five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform that was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization does not was not necessary. Receives: Other: Blood sample | |
| Hospitalized convalescent patients diagnosed with COVID + | Five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID +, hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxaemic pneumonia requiring hospitalization. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start29 Apr 2020
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Eurobio Scientific
- Responsible party
- Sponsor
- Investigators
- Frédéric COUTANT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354766
- Sponsor's protocol ID
- 69HCL20_0340
- Other IDs
- 2020-A01038-31
- Acronym
- ANTI-COV-2
- Status last verified
- Jun 2021
- First submitted
- 17 Apr 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients
- ClinicalTrials.gov ID
- NCT04354766
- Acronym / sponsor ID
- ANTI-COV-2 / 69HCL20_0340
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Eurobio Scientific
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.
The objectives of this study are :
- To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
- To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
- To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent patients diagnosed with COVID + | – | Other: Blood sampleFive convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform that was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization does not was not necessary. |
| Hospitalized convalescent patients diagnosed with COVID + | – | Other: Blood sampleFive convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID +, hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxaemic pneumonia requiring hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study relates to 10 adult subjects who were infected with SARS-Cov-2 (positivity confirmed by PCR test), who were symptomatic, and who were in the recovery phase when the blood sample was collected. Among the 10 convalescent subjects who will be sampled, we will select two distinct populations: (i) five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform which was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization was not required; (ii) five convalescent patients (minimum 12 days after the onset of symptoms), hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxemic pneumonia requiring hospitalization.
Key inclusion criteria (3 listed)
- Patient over 18 years old
- Patient who signed the study consent form
- Convalescent patient (at least 12 days after the onset of symptoms), having been sampled at Hospices Civils de Lyon for a suspected infection with SARS-Cov-2, confirmed by PCR.
Key exclusion criteria (6 listed)
- Patient treated with rituximab
- Patient treated with immunoglobulins
- Patient over 18 years old, subject to a legal protection measure (guardianship or trusteeship)
- Patient deprived of liberty
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleThis study will require a blood sample (4 ACD tubes, 20 ml) at one time. | Other | Convalescent patients diagnosed with COVID +, Hospitalized convalescent patients diagnosed with COVID + |
Primary outcome
Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
Time frame: 3 weeks
Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric COUTANT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.