COVID-19SAMONCT06968442
The Role of Obesity in Severe COVID-19 Pathophysiology
A study testing Venipuncture in people with COVID-19 and Antibody COVID-19, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in millions of deaths worldwide. As of 2024, the SARS-CoV-2 Omicron variant is the predominant strain circulating within the population, generally causing mild upper respiratory… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Antibody COVID-19
- What is being tested?
- Venipuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2025to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort 1 (obesity cohort)
- ≥18 and ≤65 years of age
- BMI ≥30 kg/m²
- Patient of Franciscus Hospital
- Cohort 2 (control cohort)
- ≥18 and ≤65 years of age
- BMI <25 kg/m²
- Healthcare workers of Franciscus Hospital
Who cannot join
- Acute infection or current systemic immunological disorders
- Use of immune-modulatory medication (i.e., corticosteroids and biologicals)
- Hormonal therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Franciscus
Rotterdam, South Holland, 3045PM
David S.Y. Ong, M.D., Ph.D., Pharm.D., M.Sc.
About this study
Official title: SARS-CoV-2 Antibody-mediated Inflammatory Responses by Macrophages in Individuals With and Without Obesity
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in millions of deaths worldwide. As of 2024, the SARS-CoV-2 Omicron variant is the predominant strain circulating within the population, generally causing mild upper respiratory tract infections. However, hospitalizations and case fatalities due to COVID-19 continue, and there is a high probability that a new human coronavirus will emerge in the future. Understanding the pathophysiology of severe COVID-19 remains highly relevant, as its mechanisms may be comparable to those of other respiratory viral infections.
SARS-CoV-2 infects human cells primarily by binding to angiotensin-converting enzyme 2 (ACE2) and type 2 transmembrane serine protease (TMPRSS2) receptors, which are both expressed in alveolar epithelial type II cells, through the virus' spike protein. In a later stage, the replication of SARS-CoV-2 and activation of resident immune cells lead to the infiltration and activation of large numbers of innate immune cells. Consequently, this results in an excessive pro-inflammatory immune response, including increased production of IL-6, a hallmark cytokine of severe COVID-19. Eventually, the excessive inflammation results in microthrombus formation and pulmonary edema.
Read more
Further studies have indicated that SARS-CoV-2 spike-specific antibodies, along with alveolar macrophages, play a pivotal role in the pathophysiology of severe COVID-19. Alveolar macrophages, which reside in the lung alveoli, are typically the first immune cells to sense pulmonary pathogens. However, these cells can also bind IgG antibodies through their Fc-receptor, leading to cellular activation. When stimulated with both a viral stimulus and anti-SARS-CoV-2 IgG antibodies from severe COVID-19 patients (a situation similar to that in the lungs of these patients) alveolar macrophages elicit a significant proinflammatory response. This response aligns with the observed post-seral conversion deterioration in COVID-19 patients.
Obesity is a significant risk factor for developing severe COVID-19, but the underlying mechanism is not well understood. Previous studies report that macrophages in obese patients are skewed towards a pro-inflammatory phenotype due to altered fatty acid contents, particularly increased saturated fatty acids. Using our in vitro obesity model, which incorporates higher saturated fatty acid contents, the investigators already demonstrated that SARS-CoV-2 antibody-mediated inflammation of alveolar macrophages is increased (unpublished data). Thus, this may explain why obese patients are more likely to develop severe COVID-19.
To validate these in vitro findings, the investigators aim to confirm these results in monocyte-derived macrophages isolated from individuals with and without obesity. Additionally, the investigators will investigate the underlying mechanisms involved in detail. This study will provide valuable insights into the role of obesity in severe COVID-19 and potentially inform therapeutic strategies for at-risk populations.
Read the detailed description
This is a mono-center, prospective cohort study involving both a test group and a control group. The test group comprises patients with obesity eligible for bariatric surgery at Franciscus Hospital, while the control group consists of age- (maximum 5-year difference) and sex-matched non-obese healthcare workers at Franciscus Hospital. Blood samples will be collected from all participants at a single time point.
Obese patients will be approached for informed consent during their intake appointments, typically weeks to months before their bariatric surgery. Blood samples will be collected before surgery or during surgery to minimize any potential adverse effects. Collaborating researchers from the surgery department will manage the inclusion of obese patients and coordinate their blood collection.
For the non-obese control group, investigators from MMI will manage participant inclusion and blood sample collection.
Participants from Franciscus Hospital with obesity (Cohort 1) and healthcare workers without obesity (Cohort 2) will undergo a single venipuncture after an 8-hour fasting period. A total of 40 mL of blood will be collected in four 10 mL EDTA tubes.
At the Medical Microbiology and Infection Control (MMI) laboratory of Franciscus, blood samples will be collected after which these are sent to the Center for Infection and Molecular Medicine (CIMM) laboratory in Amsterdam UMC. Here, blood will be processed (i.e., isolation of plasma, monocytes, and remaining peripheral blood mononuclear cells (PBMCs)), where after monocytes will be put into culture to become monocyte-derived macrophages. Macrophage stimulations and additional macrophage analyses will be performed at Amsterdam UMC. Data obtained from analyses in Amsterdam UMC will be further analyzed in Amsterdam UMC by coordinating investigator Ashwin Mak (who is also affiliated at CIMM in Amsterdam UMC) and co-investigator Dr. Jeroen den Dunnen. Monocytes and plasma will be stored in Amsterdam UMC until the end of this study, where after the remaining materials will be transported to Franciscus.
Isolated PBMCs and plasma will be transported in the following days after isolation to Franciscus MMI for T cell stimulations and antibody analyses. In the analyses overview below, the location where each analysis will be performed is noted (i.e., MMI and CIMM). Coded samples and data will be stored at Amsterdam UMC until the end of this study, where after these samples are destroyed and data are deleted. MTA and DTA documents will be prepared for the transfer of blood and data to Amsterdam UMC.
- Conditions
- COVID-19, Antibody COVID-19
- Being tested
- Venipuncture
- Keywords
- COVID-19, Obesity, Antibodies, Macrophages, Immunity, Fc receptors
- Medical subject headings
- COVID-19, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureProcedure or surgery
Also called Venapuncture, Blood collection
Simple blood collection
| Study group | Role | What they receive |
|---|---|---|
| General | Other | The intervention is a blood collection, whereafter blood will be analyzed for immunological parameters. Receives: Procedure: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of pro-inflammatory cytokines (IL-6, IL-1β, and TNF) produced by macrophages upon both SARS-CoV-2 viral and antibody costimulation.
Monocytes will be isolated from blood of participants of both groups, whereafter these are differentiated into macrophages. These macrophages will be stimulated with a virus and SARS-CoV-2 IgG combined stimulation. After the stimulation, the concentration of pro-inflammatory cytokines is measured in the supernatant of the macrophages.
Measured: Baseline
Secondary outcomes (10)
The concentration of pro-inflammatory cytokines (IL-6, IL-1β, and TNF) produced by macrophages upon separate viral stimulation or SARS-CoV-2 antibody stimulation
Monocytes will be isolated from blood of participants of both groups, whereafter these are differentiated into macrophages. These macrophages will be stimulated separately with a virus and SARS-CoV-2 IgG stimulation. After the stimulation, the concentration of pro-inflammatory cytokines is measured in the supernatant of the macrophages.
Measured: Baseline
The plasma concentration of pro-inflammatory cytokines
Pro-inflammatory cytokines will be directly measured in plasma.
Measured: Baseline
Measurement of other cytokines that are produced by macrophages upon viral stimulation, antibody stimulation, or both
Monocytes will be isolated from blood of participants of both groups, whereafter these are differentiated into macrophages. These macrophages will be stimulated with a viral stimulation, SARS-CoV-2 IgG stimulation or both combined. After the stimulations, the concentration of additional cytokines (IL-10, IFNg, IFNa, IFNb) will be measured in the supernatant of the macrophages.
Measured: Baseline
Expression levels of Fc receptors on the surface of macrophages
Macrophages will be analyzed by flow cytometry to determine the expression levels of Fc receptors (including CD16, CD32a, CD32b, CD64).
Measured: Baseline
The level of intracellular lipids in monocytes
Monocytes isolated from blood will be analyzed by flow cytometry to assess the intracellular lipid content
Measured: Baseline
Gene expression levels of proteins related to immune signalling or metabolic pathways
Molecular techniques will be applied to assess the gene expression levels of interesting proteins involved in immune signalling or metabolic pathways.
Measured: Baseline
Chromatin accessibility, measured as the number of 'reads per genomic region' of genes related to Fc-receptor activation in macrophages
ATAC-seq will be applied to determine the chromatine accessibility of genes related to Fc-receptor (i.e., receptors binding the Fc-part of antibodies) activation in macrophages. These include genes encoding for the receptors itself, as well as genes encoding for proteins related with the related intracellular signalling pathways upon Fc-receptor activation. The measured unit will be the number of reads per genomc region.
Measured: Baseline
The level of lactate production by macrophages upon stimulation with anti-SARS-CoV-2 IgG.
Lactate is the final product of the glycolysis metabolic pathway. The level of lactate produced by macrophages, thus resembling glycolysis activity, will be assessed after stimulaten with anti-SARS-CoV-2 IgG. The concentration will be measured in mM.
Measured: Baseline
The concentration of proteins in plasma
Using a proteomics approach, the concentration of over 1000 proteins will be assessed in plasma.
Measured: Baseline
The level of SARS-CoV-2 specific T cell responses and plasma antibodies
To determine the adaptive immunity against SARS-CoV-2, T cell responses and antibodies specific to SARS-CoV-2 proteins Spike, Spike S2, Spike S2, and Nucleocapsid will be assessed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start22 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion22 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators include a cohort of obesity patients (all BMI \>35) who are eligible for bariatric surgery and a control cohort of age and sex matched lean (all BMI \<25) healthcare workers. From all individuals, blood is collected and immunological analyses are performed.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S.Y. Ong, M.D., Ph.D., Pharm.D., M.Sc., Principal investigator, Franciscus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968442
- Sponsor's protocol ID
- NL88800.100.25
- Acronym
- SAMO
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested we will make the IPD available
Publications
Hoepel W, Chen HJ, Geyer CE, Allahverdiyeva S, Manz XD, de Taeye SW, Aman J, Mes L, Steenhuis M, Griffith GR, Bonta PI, Brouwer PJM, Caniels TG, van der Straten K, Golebski K, Jonkers RE, Larsen MD, Linty F, Nouta J, van Roomen CPAA, van Baarle FEHP, van Drunen CM, Wolbink G, Vlaar APJ, de Bree GJ, Sanders RW, Willemsen L, Neele AE, van de Beek D, Rispens T, Wuhrer M, Bogaard HJ, van Gils MJ, Vidarsson G, de Winther M, den Dunnen J. High titers and low fucosylation of early human anti-SARS-CoV-2 IgG promote inflammation by alveolar macrophages. Sci Transl Med. 2021 Jun 2;13(596):eabf8654. doi: 10.1126/scitranslmed.abf8654. Epub 2021 May 11.
PubMed 33979301
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Antibody-mediated Inflammatory Responses by Macrophages in Individuals With and Without Obesity
- ClinicalTrials.gov ID
- NCT06968442
- Acronym / sponsor ID
- SAMO / NL88800.100.25
- Conditions
- COVID-19, Antibody COVID-19
- Keywords
- COVID-19, Obesity, Antibodies, Macrophages, Immunity, Fc receptors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 13 May 2025 (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.
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in millions of deaths worldwide. As of 2024, the SARS-CoV-2 Omicron variant is the predominant strain circulating within the population, generally causing mild upper respiratory tract infections. However, hospitalizations and case fatalities due to COVID-19 continue, and there is a high probability that a new human coronavirus will emerge in the future. Understanding the pathophysiology of severe COVID-19 remains highly relevant, as its mechanisms may be comparable to those of other respiratory viral infections.
SARS-CoV-2 infects human cells primarily by binding to angiotensin-converting enzyme 2 (ACE2) and type 2 transmembrane serine protease (TMPRSS2) receptors, which are both expressed in alveolar epithelial type II cells, through the virus' spike protein. In a later stage, the replication of SARS-CoV-2 and activation of resident immune cells lead to the infiltration and activation of large numbers of innate immune cells. Consequently, this results in an excessive pro-inflammatory immune response, including increased production of IL-6, a hallmark cytokine of severe COVID-19. Eventually, the excessive inflammation results in microthrombus formation and pulmonary edema.
Further studies have indicated that SARS-CoV-2 spike-specific antibodies, along with alveolar macrophages, play a pivotal role in the pathophysiology of severe COVID-19. Alveolar macrophages, which reside in the lung alveoli, are typically the first immune cells to sense pulmonary pathogens. However, these cells can also bind IgG antibodies through their Fc-receptor, leading to cellular activation. When stimulated with both a viral stimulus and anti-SARS-CoV-2 IgG antibodies from severe COVID-19 patients (a situation similar to that in the lungs of these patients) alveolar macrophages elicit a significant proinflammatory response. This response aligns with the observed post-seral conversion deterioration in COVID-19 patients.
Obesity is a significant risk factor for developing severe COVID-19, but the underlying mechanism is not well understood. Previous studies report that macrophages in obese patients are skewed towards a pro-inflammatory phenotype due to altered fatty acid contents, particularly increased saturated fatty acids. Using our in vitro obesity model, which incorporates higher saturated fatty acid contents, the investigators already demonstrated that SARS-CoV-2 antibody-mediated inflammation of alveolar macrophages is increased (unpublished data). Thus, this may explain why obese patients are more likely to develop severe COVID-19.
To validate these in vitro findings, the investigators aim to confirm these results in monocyte-derived macrophages isolated from individuals with and without obesity. Additionally, the investigators will investigate the underlying mechanisms involved in detail. This study will provide valuable insights into the role of obesity in severe COVID-19 and potentially inform therapeutic strategies for at-risk populations.
Detailed description
This is a mono-center, prospective cohort study involving both a test group and a control group. The test group comprises patients with obesity eligible for bariatric surgery at Franciscus Hospital, while the control group consists of age- (maximum 5-year difference) and sex-matched non-obese healthcare workers at Franciscus Hospital. Blood samples will be collected from all participants at a single time point.
Obese patients will be approached for informed consent during their intake appointments, typically weeks to months before their bariatric surgery. Blood samples will be collected before surgery or during surgery to minimize any potential adverse effects. Collaborating researchers from the surgery department will manage the inclusion of obese patients and coordinate their blood collection.
For the non-obese control group, investigators from MMI will manage participant inclusion and blood sample collection.
Participants from Franciscus Hospital with obesity (Cohort 1) and healthcare workers without obesity (Cohort 2) will undergo a single venipuncture after an 8-hour fasting period. A total of 40 mL of blood will be collected in four 10 mL EDTA tubes.
At the Medical Microbiology and Infection Control (MMI) laboratory of Franciscus, blood samples will be collected after which these are sent to the Center for Infection and Molecular Medicine (CIMM) laboratory in Amsterdam UMC. Here, blood will be processed (i.e., isolation of plasma, monocytes, and remaining peripheral blood mononuclear cells (PBMCs)), where after monocytes will be put into culture to become monocyte-derived macrophages. Macrophage stimulations and additional macrophage analyses will be performed at Amsterdam UMC. Data obtained from analyses in Amsterdam UMC will be further analyzed in Amsterdam UMC by coordinating investigator Ashwin Mak (who is also affiliated at CIMM in Amsterdam UMC) and co-investigator Dr. Jeroen den Dunnen. Monocytes and plasma will be stored in Amsterdam UMC until the end of this study, where after the remaining materials will be transported to Franciscus.
Isolated PBMCs and plasma will be transported in the following days after isolation to Franciscus MMI for T cell stimulations and antibody analyses. In the analyses overview below, the location where each analysis will be performed is noted (i.e., MMI and CIMM). Coded samples and data will be stored at Amsterdam UMC until the end of this study, where after these samples are destroyed and data are deleted. MTA and DTA documents will be prepared for the transfer of blood and data to Amsterdam UMC.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators include a cohort of obesity patients (all BMI >35) who are eligible for bariatric surgery and a control cohort of age and sex matched lean (all BMI <25) healthcare workers. From all individuals, blood is collected and immunological analyses are performed.
| Arm | Type | Receives |
|---|---|---|
| General | Other | Procedure: VenipunctureThe intervention is a blood collection, whereafter blood will be analyzed for immunological parameters. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cohort 1 (obesity cohort)
- ≥18 and ≤65 years of age
- BMI ≥30 kg/m²
- Patient of Franciscus Hospital
- Cohort 2 (control cohort)
Key exclusion criteria (3 listed)
- Acute infection or current systemic immunological disorders
- Use of immune-modulatory medication (i.e., corticosteroids and biologicals)
- Hormonal therapy
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 |
|---|---|---|
| VenipunctureAlso: Venapuncture, Blood collectionSimple blood collection | Procedure or surgery | General |
Primary outcome
The concentration of pro-inflammatory cytokines (IL-6, IL-1β, and TNF) produced by macrophages upon both SARS-CoV-2 viral and antibody costimulation.
Time frame: Baseline
Monocytes will be isolated from blood of participants of both groups, whereafter these are differentiated into macrophages. These macrophages will be stimulated with a virus and SARS-CoV-2 IgG combined stimulation. After the stimulation, the concentration of pro-inflammatory cytokines is measured in the supernatant of the macrophages.
10 secondary outcomes
The concentration of pro-inflammatory cytokines (IL-6, IL-1β, and TNF) produced by macrophages upon separate viral stimulation or SARS-CoV-2 antibody stimulation
Time frame: Baseline
The plasma concentration of pro-inflammatory cytokines
Time frame: Baseline
Measurement of other cytokines that are produced by macrophages upon viral stimulation, antibody stimulation, or both
Time frame: Baseline
Expression levels of Fc receptors on the surface of macrophages
Time frame: Baseline
The level of intracellular lipids in monocytes
Time frame: Baseline
Gene expression levels of proteins related to immune signalling or metabolic pathways
Time frame: Baseline
Chromatin accessibility, measured as the number of 'reads per genomic region' of genes related to Fc-receptor activation in macrophages
Time frame: Baseline
The level of lactate production by macrophages upon stimulation with anti-SARS-CoV-2 IgG.
Time frame: Baseline
The concentration of proteins in plasma
Time frame: Baseline
The level of SARS-CoV-2 specific T cell responses and plasma antibodies
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 33979301Hoepel W, Chen HJ, Geyer CE, Allahverdiyeva S, Manz XD, de Taeye SW, Aman J, Mes L, Steenhuis M, Griffith GR, Bonta PI, Brouwer PJM, Caniels TG, van der Straten K, Golebski K, Jonkers RE, Larsen MD, Linty F, Nouta J, van Roomen CPAA, van Baarle FEHP, van Drunen CM, Wolbink G, Vlaar APJ, de Bree GJ, Sanders RW, Willemsen L, Neele AE, van de Beek D, Rispens T, Wuhrer M, Bogaard HJ, van Gils MJ, Vidarsson G, de Winther M, den Dunnen J. High titers and low fucosylation of early human anti-SARS-CoV-2 IgG promote inflammation by alveolar macrophages. Sci Transl Med. 2021 Jun 2;13(596):eabf8654. doi: 10.1126/scitranslmed.abf8654. Epub 2021 May 11.
- Individual participant dataSharing planned: Undecided. If requested we will make the IPD available
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
David S.Y. Ong, M.D., Ph.D., Pharm.D., M.Sc. principal investigator
Franciscus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture in people with COVID-19 and Antibody COVID-19, run by Franciscus Gasthuis at 1 site in Netherlands.
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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Willem A Mak, M.Sc. (+316 40897778, ashwinmak98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of pro-inflammatory cytokines (IL-6, IL-1β, and TNF) produced by macrophages upon both SARS-CoV-2 viral and antibody costimulation. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968442, which also lists 1 linked publication.
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 16 May 2025.