Immune Responses to COVID-19; Isolation of Neutralizing Antibodies for Therapeutics and Vaccine.
NCT ID: NCT04596098
Last Updated: 2023-08-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
55 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-04-30
Study Completion Date
2022-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
NCT05315583
COVID-19
SARS CoV 2 Infection
TERMINATED
NA
Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients
NCT05905380
COVID-19 Convalescent Plasma Treatment
UNKNOWN
Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection
NCT04750720
Covid19
SARS-CoV-2
COMPLETED
NA
Study of Immune Response During SARS-CoV-2 Infection - (COVID-19)
NCT04355351
New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2
COMPLETED
NA
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
NCT04637867
Infection Viral
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A RELIRE PAR PASCAL POIGNARD
1. CURRENT KNOWLEDGE ABOUT THE PATHOLOGY
Coronaviruses are a large family whose members share a tropism for epitheliums. They are usually responsible of ordinary and frequent infections in humans, with acute and limited inflammation of the respiratory tract. The fact that they are RNA viruses (which confers them an important plasticity), and that some types infect animals and others infect human, explain that they may be a source of new human diseases arising from animal strains. This is how two Coronavirus outbreaks spreading in several countries emerged in the past years: The Severe Acute Respiratory Syndrome (SARS), in 2003; and the Middle East Respiratory Syndrome (MERS) in 2012. In January 2020, another coronavirus outbreak has been described: the COVID-19 outbreak, related to the SARS-CoV-2.
The disease mentioned as coronavirus disease 2019 (COVID-19) has been detected for the first time in China in December 2019; a first case cluster was strongly related to a live-animal market, suggesting an animal origin; the following descriptions did clearly established a human-to-human transmission, with a reproduction number (R0) between 2.5 and 3.5. Some scientific publications described potential contaminations by asymptomatic subjects. While China finally managed to record a great decrease in the number of daily cases (82,241 total cases with 3,309 deaths on the 31st March 2020), the epidemic rapidly reached many other countries. In France, several sites of active virus circulation (l'Oise, Mulhouse, la Haute-Savoie) finally led to an important development of the epidemic in France (44,450 cases with 3,024 deaths on March 31st 2020).
The disease consists in a pneumonia reminding of the Acute Respiratory Distress Syndrome (ARDS) in several aspects; after a 5 days median incubation time, symptoms develops with cough which can be febrile/feverish, and which can evolve/develop towards dyspnea, and in some instance towards ARDS after 7 to 10 days of evolution. If the first epidemiological descriptions stated a high proportion of severe cases (more than 33%), a study including more than 70,000 cases then suggested that 15% cases were severe/marked, and 5% critical; however, it is likely that asymptomatic or little symptomatic cases can be numerous, according to new studies. To date, no curative antiviral treatment demonstrated clinical efficacy but many clinical trials are ongoing. This disease is a problem for the healthcare system for two reasons: its contagiousness (which require major social distancing measures) and its morbidity (which paralyze the healthcare system by requiring too much ICU hospitalization).
2. IMMUNE RESPONSES IN COVID-19 STATE OF ART:
The main aim of this study is therefore to explore the antibody responses in SARS-CoV-2 infection and in fine identify and then produce neutralizing monoclonal antibodies for therapeutic and vaccine use.
In SARS infected patients, antibody responses appears usually early, in the two weeks following the first symptoms and last for at least 16 months after the disease beginning. Neutralizing responses appear early too, but tend to wane quickly after 16 months. Interestingly, it has been shown that antibodies targeting SARS-CoV are able to neutralize SARS-CoV-2, suggesting the existence of neutralizing antibodies (3). This could be explained by the relatively high conservation between the two viruses envelop glycoproteins (about 77% of sequence homology, a very similar structure and the use of the same cellular receptor ACE2), which are the targets of neutralizing antibodies. During MERS-CoV infection, it has also been showed that antibody responses appear in the second week of infection and last during at least 18 months. A neutralizing response anti-MERS-CoV has been described: the viral load of patients being inversely proportional to the neutralizing Ab levels. Those neutralizing antibodies alone are not sufficient for infection clearance (4). Interestingly, the protective antibody response against other coronaviruses as OC43 and 229E seems much more of limited in time (5).
A characterization of the antibody response during COVID-19, especially the neutralizing activity, is important for the progress it will allow:
* To understand the nature and duration of the potentially protective humoral response during and following the infection by SARS-CoV-2
* To study the evolution of IgM and IgG antibody responses against SARS-CoV-2 surface glycoproteins, especially the spike protein (SARS2-S)
* To study neutralizing antibody responses evolution. Indeed, it is essential to better understand in what extend a strong humoral immunity is generated in all infected patients, if this response varies accordingly to the infection severity and duration.
* To screen patients' sera looking for individuals showing high neutralization titers and perhaps for neutralizing antibodies against different coronaviruses. It is essential to understand if some patients can produce neutralizing antibodies, able to neutralize different coronaviruses.
* To study the existence of a potential viral infection facilitation by antibodies. Indeed, the increase of infectivity mediated by antibodies has been described for other coronaviruses and could the vaccine development more challenging (6).
Following this characterization, the investigators will be able to isolate human monoclonal antibodies from selected patients. Antibody isolation could notably enable therapeutic and vaccine approaches in the future, to treat and prevent not only the COVID-19, but also other already existing coronavirus infections or in case of a new coronavirus outbreak.
Thus, the most promising monoclonal antibodies (high affinity, high neutralizing capacity) will be selected and optimized for a future development as therapeutic agent (lead compounds).
In fine, the investigators will be able to use isolated monoclonal antibodies as tools in structural approaches for the neutralization epitopes determination and the development of vaccine approaches (reverse vaccinology).
In order to isolate human monoclonal antibodies in individuals selected for their humoral response of interest, the specific IgG positive memory B cells bearing antibodies against the selected targets at their surface, are sorted by flow cytometry. As part of this project, B cells producing antibodies recognizing SARS-2-S biotinylated recombinant proteins conjugated to fluorochrome-labelled streptavidin will be sorted. These proteins are produced by transfection of 293F cells and are then purified. An alternative strategy consists in activating B cells and screening supernatants for the presence of specific neutralizing antibodies in micro-neutralization assays involving for example the use of viruses pseudotyped with SARS-2-S. After identifying the specific B cells, the immunoglobulin genes of interest will be amplified by PCR from clonal cell in order to identify the heavy and light (lambda or kappa) chains, accordingly to methods previously used for the isolation of antibodies against HIV (7-10).
Amplified heavy and light chains are subsequently cloned in expression vector by homologous recombination. The corresponding antibodies are produced by 293F cell transfection with the appropriate combination of heavy and light chains. After purification and reactivity testing against SARS-2-S protein, we'll evaluate neutralizing function to identify and prioritize the candidates for a deeper characterization in order to identify lead compounds.
3. BIOMARKERS:
In addition, the investigators aim to explore the other immunity players, immune cells, complement and cytokines, with the aim of identifying predictive biomarkers of a poor prognosis. These lab analyses could be able to predict poor prognosis ad could contribute to adapt medical care.
The investigations will include:
* T, B and NK lymphocytes subpopulation and monocyte HLA-DR subpopulation studied by flow cytometry.
* the study of complement system (C3, C4, CH50 \& CH50a).
* the study of cytokines ant notably the measurement of IL-6 and IL-10 at Days 1, 3 and 7 of patient hospitalization.
4. RESEARCH HYPOTHESIS AND EXPECTED RESULTS The investigators will be able to monitor antibody responses targeting the envelop glycoproteins of SARS-CoV-2 and identify subjects showing an immune response with high titers of neutralizing antibodies targeting SARS-CoV-2. This will allow the isolation of monoclonal antibodies from patients' memory B lymphocytes for therapeutic and vaccine purposes.
Moreover, the immunity investigation in COVID-19 patients will enable the identification of severity and worsening biomarkers.
5. RESEARCH CONDUCT
The selection is achieved based on the medical record for every patient:
* who had a positive diagnostic result of COVID-19 RT-PCR
* hospitalized for less than 48h at the CHUGA and who have symptoms resulting from the infection.
It is followed by an inclusion visit during which an investigating doctor clinically examines the patient.
This doctor checks the inclusion and non-inclusion criteria, exposes the trial to the patient and collects the patient non-opposition and sampling consent (Appendix 2). It is followed by the biological tests related to care, to research and to data collection (see §7.3)
The follow-up visits (visits 2 to 8 from day 3 to day 30) happen as established in the study calendar over the month following inclusion. An investigating doctor clinically examines the patient, a nurse then does blood sampling related to care and research (biomarkers at day 1, 3 and 7 and biological collection on day 1, 3, 7, 13, last hospitalization day) and a clinical research assistant does data collection. The blood sample (serum and peripheral mononuclear blood cells from day 1, 13, last hospitalization day) are the samples necessary for the primary criteria of this study.
The visits subsequent to day 7 (visits 5 to 8) only occur if the patient is still hospitalized. In other words, the end of the hospitalization stay establishes the end of the study for group A.
An optional visit can take place for group b patients. It happens 2 to 6 months after inclusion when the patient is regularly followed up at the CHUGA and when a visit with blood sampling is scheduled which would enable the collection of useful samples for the research.
1. CURRENT KNOWLEDGE ABOUT THE PATHOLOGY
Coronaviruses are a large family whose members share a tropism for epitheliums. They are usually responsible of ordinary and frequent infections in humans, with acute and limited inflammation of the respiratory tract. The fact that they are RNA viruses (which confers them an important plasticity), and that some types infect animals and others infect human, explain that they may be a source of new human diseases arising from animal strains. This is how two Coronavirus outbreaks spreading in several countries emerged in the past years: The Severe Acute Respiratory Syndrome (SARS), in 2003; and the Middle East Respiratory Syndrome (MERS) in 2012. In January 2020, another coronavirus outbreak has been described: the COVID-19 outbreak, related to the SARS-CoV-2.
The disease mentioned as coronavirus disease 2019 (COVID-19) has been detected for the first time in China in December 2019; a first case cluster was strongly related to a live-animal market, suggesting an animal origin; the following descriptions did clearly established a human-to-human transmission, with a reproduction number (R0) between 2.5 and 3.5. Some scientific publications described potential contaminations by asymptomatic subjects. While China finally managed to record a great decrease in the number of daily cases (82,241 total cases with 3,309 deaths on the 31st March 2020), the epidemic rapidly reached many other countries. In France, several sites of active virus circulation (l'Oise, Mulhouse, la Haute-Savoie) finally led to an important development of the epidemic in France (44,450 cases with 3,024 deaths on March 31st 2020).
The disease consists in a pneumonia reminding of the Acute Respiratory Distress Syndrome (ARDS) in several aspects; after a 5 days median incubation time, symptoms develops with cough which can be febrile/feverish, and which can evolve/develop towards dyspnea, and in some instance towards ARDS after 7 to 10 days of evolution. If the first epidemiological descriptions stated a high proportion of severe cases (more than 33%), a study including more than 70,000 cases then suggested that 15% cases were severe/marked, and 5% critical; however, it is likely that asymptomatic or little symptomatic cases can be numerous, according to new studies. To date, no curative antiviral treatment demonstrated clinical efficacy but many clinical trials are ongoing. This disease is a problem for the healthcare system for two reasons: its contagiousness (which require major social distancing measures) and its morbidity (which paralyze the healthcare system by requiring too much ICU hospitalization).
2. IMMUNE RESPONSES IN COVID-19 STATE OF ART:
The main aim of this study is therefore to explore the antibody responses in SARS-CoV-2 infection and in fine identify and then produce neutralizing monoclonal antibodies for therapeutic and vaccine use.
In SARS infected patients, antibody responses appears usually early, in the two weeks following the first symptoms and last for at least 16 months after the disease beginning. Neutralizing responses appear early too, but tend to wane quickly after 16 months. Interestingly, it has been shown that antibodies targeting SARS-CoV are able to neutralize SARS-CoV-2, suggesting the existence of neutralizing antibodies (3). This could be explained by the relatively high conservation between the two viruses envelop glycoproteins (about 77% of sequence homology, a very similar structure and the use of the same cellular receptor ACE2), which are the targets of neutralizing antibodies. During MERS-CoV infection, it has also been showed that antibody responses appear in the second week of infection and last during at least 18 months. A neutralizing response anti-MERS-CoV has been described: the viral load of patients being inversely proportional to the neutralizing Ab levels. Those neutralizing antibodies alone are not sufficient for infection clearance (4). Interestingly, the protective antibody response against other coronaviruses as OC43 and 229E seems much more of limited in time (5).
A characterization of the antibody response during COVID-19, especially the neutralizing activity, is important for the progress it will allow:
* To understand the nature and duration of the potentially protective humoral response during and following the infection by SARS-CoV-2
* To study the evolution of IgM and IgG antibody responses against SARS-CoV-2 surface glycoproteins, especially the spike protein (SARS2-S)
* To study neutralizing antibody responses evolution. Indeed, it is essential to better understand in what extend a strong humoral immunity is generated in all infected patients, if this response varies accordingly to the infection severity and duration.
* To screen patients' sera looking for individuals showing high neutralization titers and perhaps for neutralizing antibodies against different coronaviruses. It is essential to understand if some patients can produce neutralizing antibodies, able to neutralize different coronaviruses.
* To study the existence of a potential viral infection facilitation by antibodies. Indeed, the increase of infectivity mediated by antibodies has been described for other coronaviruses and could the vaccine development more challenging (6).
Following this characterization, the investigators will be able to isolate human monoclonal antibodies from selected patients. Antibody isolation could notably enable therapeutic and vaccine approaches in the future, to treat and prevent not only the COVID-19, but also other already existing coronavirus infections or in case of a new coronavirus outbreak.
Thus, the most promising monoclonal antibodies (high affinity, high neutralizing capacity) will be selected and optimized for a future development as therapeutic agent (lead compounds).
In fine, the investigators will be able to use isolated monoclonal antibodies as tools in structural approaches for the neutralization epitopes determination and the development of vaccine approaches (reverse vaccinology).
In order to isolate human monoclonal antibodies in individuals selected for their humoral response of interest, the specific IgG positive memory B cells bearing antibodies against the selected targets at their surface, are sorted by flow cytometry. As part of this project, B cells producing antibodies recognizing SARS-2-S biotinylated recombinant proteins conjugated to fluorochrome-labelled streptavidin will be sorted. These proteins are produced by transfection of 293F cells and are then purified. An alternative strategy consists in activating B cells and screening supernatants for the presence of specific neutralizing antibodies in micro-neutralization assays involving for example the use of viruses pseudotyped with SARS-2-S. After identifying the specific B cells, the immunoglobulin genes of interest will be amplified by PCR from clonal cell in order to identify the heavy and light (lambda or kappa) chains, accordingly to methods previously used for the isolation of antibodies against HIV (7-10).
Amplified heavy and light chains are subsequently cloned in expression vector by homologous recombination. The corresponding antibodies are produced by 293F cell transfection with the appropriate combination of heavy and light chains. After purification and reactivity testing against SARS-2-S protein, we'll evaluate neutralizing function to identify and prioritize the candidates for a deeper characterization in order to identify lead compounds.
3. BIOMARKERS:
In addition, the investigators aim to explore the other immunity players, immune cells, complement and cytokines, with the aim of identifying predictive biomarkers of a poor prognosis. These lab analyses could be able to predict poor prognosis ad could contribute to adapt medical care.
The investigations will include:
* T, B and NK lymphocytes subpopulation and monocyte HLA-DR subpopulation studied by flow cytometry.
* the study of complement system (C3, C4, CH50 \& CH50a).
* the study of cytokines ant notably the measurement of IL-6 and IL-10 at Days 1, 3 and 7 of patient hospitalization.
4. RESEARCH HYPOTHESIS AND EXPECTED RESULTS The investigators will be able to monitor antibody responses targeting the envelop glycoproteins of SARS-CoV-2 and identify subjects showing an immune response with high titers of neutralizing antibodies targeting SARS-CoV-2. This will allow the isolation of monoclonal antibodies from patients' memory B lymphocytes for therapeutic and vaccine purposes.
Moreover, the immunity investigation in COVID-19 patients will enable the identification of severity and worsening biomarkers.
5. RESEARCH CONDUCT
The selection is achieved based on the medical record for every patient:
* who had a positive diagnostic result of COVID-19 RT-PCR
* hospitalized for less than 48h at the CHUGA and who have symptoms resulting from the infection.
It is followed by an inclusion visit during which an investigating doctor clinically examines the patient.
This doctor checks the inclusion and non-inclusion criteria, exposes the trial to the patient and collects the patient non-opposition and sampling consent (Appendix 2). It is followed by the biological tests related to care, to research and to data collection (see §7.3)
The follow-up visits (visits 2 to 8 from day 3 to day 30) happen as established in the study calendar over the month following inclusion. An investigating doctor clinically examines the patient, a nurse then does blood sampling related to care and research (biomarkers at day 1, 3 and 7 and biological collection on day 1, 3, 7, 13, last hospitalization day) and a clinical research assistant does data collection. The blood sample (serum and peripheral mononuclear blood cells from day 1, 13, last hospitalization day) are the samples necessary for the primary criteria of this study.
The visits subsequent to day 7 (visits 5 to 8) only occur if the patient is still hospitalized. In other words, the end of the hospitalization stay establishes the end of the study for group A.
An optional visit can take place for group b patients. It happens 2 to 6 months after inclusion when the patient is regularly followed up at the CHUGA and when a visit with blood sampling is scheduled which would enable the collection of useful samples for the research.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
SARS-CoV 2
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Patient hospitalized in Grenoble University Hospital for CoViD19. Patient not previously followed in Grenoble University Hospital for a chronic disease.
Blood sampling
Intervention Type
OTHER
During a care-related blood sampling, patient will provide additional blood sample for research purpuse.
Group B
Patient hospitalized in Grenoble University Hospital for CoViD19. Patient followed in Grenoble University Hospital for a chronic disease.
Blood sampling
Intervention Type
OTHER
During a care-related blood sampling, patient will provide additional blood sample for research purpuse.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sampling
During a care-related blood sampling, patient will provide additional blood sample for research purpuse.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Biological collection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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… )
* 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… )
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Commissariat A L'energie Atomique
OTHER_GOV
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pascal POIGNARD, PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UniversityGrenobleHospital
Grenoble, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
References
Explore related publications, articles, or registry entries linked to this study.
Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
Reference Type
BACKGROUND
Haveri A, Smura T, Kuivanen S, Osterlund P, Hepojoki J, Ikonen N, Pitkapaasi M, Blomqvist S, Ronkko E, Kantele A, Strandin T, Kallio-Kokko H, Mannonen L, Lappalainen M, Broas M, Jiang M, Siira L, Salminen M, Puumalainen T, Sane J, Melin M, Vapalahti O, Savolainen-Kopra C. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020. Euro Surveill. 2020 Mar;25(11):2000266. doi: 10.2807/1560-7917.ES.2020.25.11.2000266.
Reference Type
BACKGROUND
Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19.
Reference Type
BACKGROUND
Alshukairi AN, Khalid I, Ahmed WA, Dada AM, Bayumi DT, Malic LS, Althawadi S, Ignacio K, Alsalmi HS, Al-Abdely HM, Wali GY, Qushmaq IA, Alraddadi BM, Perlman S. Antibody Response and Disease Severity in Healthcare Worker MERS Survivors. Emerg Infect Dis. 2016 Jun;22(6):1113-5. doi: 10.3201/eid2206.160010.
Reference Type
BACKGROUND
Liu W, Fontanet A, Zhang PH, Zhan L, Xin ZT, Baril L, Tang F, Lv H, Cao WC. Two-year prospective study of the humoral immune response of patients with severe acute respiratory syndrome. J Infect Dis. 2006 Mar 15;193(6):792-5. doi: 10.1086/500469. Epub 2006 Feb 9.
Reference Type
BACKGROUND
Tetro JA. Is COVID-19 receiving ADE from other coronaviruses? Microbes Infect. 2020 Mar;22(2):72-73. doi: 10.1016/j.micinf.2020.02.006. Epub 2020 Feb 22.
Reference Type
BACKGROUND
Walker LM, Phogat SK, Chan-Hui PY, Wagner D, Phung P, Goss JL, Wrin T, Simek MD, Fling S, Mitcham JL, Lehrman JK, Priddy FH, Olsen OA, Frey SM, Hammond PW; Protocol G Principal Investigators; Kaminsky S, Zamb T, Moyle M, Koff WC, Poignard P, Burton DR. Broad and potent neutralizing antibodies from an African donor reveal a new HIV-1 vaccine target. Science. 2009 Oct 9;326(5950):285-9. doi: 10.1126/science.1178746. Epub 2009 Sep 3.
Reference Type
BACKGROUND
Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators; Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373.
Reference Type
BACKGROUND
MacLeod DT, Choi NM, Briney B, Garces F, Ver LS, Landais E, Murrell B, Wrin T, Kilembe W, Liang CH, Ramos A, Bian CB, Wickramasinghe L, Kong L, Eren K, Wu CY, Wong CH; IAVI Protocol C Investigators & The IAVI African HIV Research Network; Kosakovsky Pond SL, Wilson IA, Burton DR, Poignard P. Early Antibody Lineage Diversification and Independent Limb Maturation Lead to Broad HIV-1 Neutralization Targeting the Env High-Mannose Patch. Immunity. 2016 May 17;44(5):1215-26. doi: 10.1016/j.immuni.2016.04.016.
Reference Type
BACKGROUND
Landais E, Murrell B, Briney B, Murrell S, Rantalainen K, Berndsen ZT, Ramos A, Wickramasinghe L, Smith ML, Eren K, de Val N, Wu M, Cappelletti A, Umotoy J, Lie Y, Wrin T, Algate P, Chan-Hui PY, Karita E; IAVI Protocol C Investigators; IAVI African HIV Research Network; Ward AB, Wilson IA, Burton DR, Smith D, Pond SLK, Poignard P. HIV Envelope Glycoform Heterogeneity and Localized Diversity Govern the Initiation and Maturation of a V2 Apex Broadly Neutralizing Antibody Lineage. Immunity. 2017 Nov 21;47(5):990-1003.e9. doi: 10.1016/j.immuni.2017.11.002.
Reference Type
BACKGROUND
Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19. No abstract available.
Reference Type
BACKGROUND
Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
Reference Type
BACKGROUND
Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.
Reference Type
BACKGROUND
Lin L, Lu L, Cao W, Li T. Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia. Emerg Microbes Infect. 2020 Dec;9(1):727-732. doi: 10.1080/22221751.2020.1746199.
Reference Type
BACKGROUND
Saylor C, Dadachova E, Casadevall A. Monoclonal antibody-based therapies for microbial diseases. Vaccine. 2009 Dec 30;27 Suppl 6:G38-46. doi: 10.1016/j.vaccine.2009.09.105.
Reference Type
BACKGROUND
Casadevall A. Antibody-based vaccine strategies against intracellular pathogens. Curr Opin Immunol. 2018 Aug;53:74-80. doi: 10.1016/j.coi.2018.04.011. Epub 2018 Apr 25.
Reference Type
BACKGROUND
Stadlbauer D, Amanat F, Chromikova V, Jiang K, Strohmeier S, Arunkumar GA, Tan J, Bhavsar D, Capuano C, Kirkpatrick E, Meade P, Brito RN, Teo C, McMahon M, Simon V, Krammer F. SARS-CoV-2 Seroconversion in Humans: A Detailed Protocol for a Serological Assay, Antigen Production, and Test Setup. Curr Protoc Microbiol. 2020 Jun;57(1):e100. doi: 10.1002/cpmc.100.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A00904-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
38RC20.132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection
NCT04707820
COMPLETED
NA
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)
NCT04429594
RECRUITING
NA
Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff
NCT04896788
UNKNOWN
NA
Effect of a Vaccination Against COVID-19 on Monocyte Production of Oxygenated Derivatives.
NCT05655351
COMPLETED
EARLY_PHASE1
COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
NCT04369066
COMPLETED
NA
Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen
NCT04707833
UNKNOWN
NA
Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra
NCT05172167
UNKNOWN
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
NCT04888793
COMPLETED
Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19
NCT05092607
UNKNOWN
NA
Determination of the Hemoadsorption Impact as Adjunctive Treatment Upon the Support Therapy of COVID-19
NCT04518969
COMPLETED
NA
COVID-19 in PID Survey
NCT04459689
RECRUITING
Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers
NCT04525417
COMPLETED
NA
Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19
NCT04550390
COMPLETED
TREM-1 Pathway Activation in COVID-19
NCT04544891
COMPLETED
Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.
NCT04322279
TERMINATED
Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution
NCT04664023
COMPLETED
Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
NCT04355533
COMPLETED
NA
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
NCT04418206
COMPLETED
NA
TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2
NCT05195060
COMPLETED
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
NCT05000307
COMPLETED
NA
Evaluation of Humoral Immunity Following COVID-19 in Pregnancy
NCT04568044
ACTIVE_NOT_RECRUITING
Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024
NCT06683937
NOT_YET_RECRUITING
Immunology of the Infection Perinatal
NCT01055873
COMPLETED
SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19
NCT04979871
COMPLETED
Investigating Immune Escape by SARS-CoV-2 Variants
NCT05171803
COMPLETED