Obesity, COVID-19 InfectionPhase 2NIVISCONCT04413838
Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection
A Phase 2 study testing NIVOLUMAB in people with Obesity, COVID-19 Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, COVID-19 Infection
- What is being tested?
- NIVOLUMAB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 15 Sep 2021
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 70 years old
- COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2)
- Hospitalized patients
- Obese individuals (BMI≥30kg/m²)
- Lymphocyte counts between 500 and 1500/mm3.
- Patients upon oxygen (either using mask or nasal cannula).
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- Patients within their first 7 days after the beginning of symptoms.
- Women of childbearing potential: effective contraception for the duration of the study and 5 months after the administration of treatment.
- Patient who understands and accepts the need for a long term follow-up,
- Patients who agrees to be included in the study and who signs the informed consent form,
- Patients affiliated to a healthcare insurance plan.
Who cannot join
- CRITERIA LINKED TO THE DISEASE SEVERITY :
- Patients hospitalized in ICU or constant care unit.
- Patients with clinical symptoms requiring ICU admission (respiratory rate>30/min, oxygen requirement> 4Liters/min (using high concentration mask) to reach and maintain O2saturation>90%, qSOFA≥ 2(quick score of Sepsis-related Organ Failure Assessment), or associated multi-visceral failure.
- Patients with high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND AST > 30 U/l AND ferritin > 600 mg/l).
- CRITERIA LINKED TO THE TREATMENT TOXICITY :
- Patients currently treated for cancer or with personal history of cancer within the last 3 years.
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- Patients with Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 and 4 stages).
- Chronic respiratory insufficiency treated with oxygen.
- Patients aged above 70 years old.
- Active smoking.
- Personal history of thoracic radiotherapy.
- Patients with known sensibility to NIVOLUMAB or one of its component.
- Patients upon immunosuppressive dosage of corticoids.
- Patients upon immunosuppressive therapy or immunosuppressed patients.
- Patients already presenting severe autoimmune disease, for whom additional immunologic activation response would potentially precipitate lethal prognosis
- GENERAL CRITERIA:
- Minor Patients
- Mentally unbalanced patients, under supervision or guardianship,
- Patient deprived of liberty,
- Patient who does not understand French/ is unable to give consent,
- Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
- Pregnant (controlled by a pregnancy test) or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lyon Sud Service Endocrinologie, Diabète et Nutrition
Pierre-Bénite, 69495
Pr
Emmanuel DISSE
About this study
Official title: Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus).
Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19.
Read more
In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production.
This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15
- Conditions
- Obesity, COVID-19 Infection
- Being tested
- NIVOLUMAB, Routine standard of care
- Keywords
- COVID-19, Obesity, Nivolumab, Immunotherapy, Anti-PD1
- Medical subject headings
- Obesity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVOLUMABDrug
IV injection within 30 minutes of 24ml file (=240 mg) containing NIVOLUMAB BMS(Bristol-Myers Squibb) 10mg/ml (immune check point inhibitor targeting PD-1) on top of routine standard of care for COVID-19 infection
Routine standard of careOther
No intervention is planned in this arm. Patients will follow routine standard of care for the COVID-19 treatment
| Study group | Role | What they receive |
|---|---|---|
| NIVOLUMAB on top of routine standard of care | Experimental | This correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND aspartate aminotransferase (AST) > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a NIVOLUMAB treatment and routine standard of care for COVID-19 infection at the time of study inclusion Receives: Drug: NIVOLUMAB |
| Standard of care for COVID-19 infection | Other | This correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND AST > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a routine standard of care for COVID-19 infection at the time of study inclusion Receives: Other: Routine standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's clinical state
Patient's clinical state will be evaluated by the proportion of patients able to be weaned of oxygen at D15 after randomization (randomization date is the day where the experimental treatment (i.e. NIVOLUMAB) is administered).
Measured: 15 days after randomization
Secondary outcomes (28)
Readmission
Proportion of in-coming patients in ICU at D7 and D15 post-randomization
Measured: 7 days and 15 days after randomization
Mortality
Proportion of death at D7 and D15 post-randomization
Measured: 7 days and 15 days after randomization
Oxygen flow needs
Proportion of patients weaned out of oxygen at D7 post-randomization
Measured: 7 days after randomization
Requirement of oxygen
Mean oxygen flow needed
Measured: 7 days and 15 days after randomization
Discharge from hospital
Proportion of out-coming patients from hospitalization at D7 and D15 post-randomization
Measured: 7 days and 15 days after randomization
Adverse events
Report of all adverse events linked or not to experimental treatment during the study
Measured: Within 15 days post-randomization and 90 days and 6 months after randomization
Presence of nasopharyngeal SARS-CoV-2
Presence or not of nasopharyngeal SARS-CoV-2 determined by PCR response
Measured: On day 0 before randomization and 15 days after randomization
nasopharyngeal SARS-CoV-2 viral charge
Presence or not of nasopharyngeal SARS-CoV-2 Quantified by PCR
Measured: On day 0 before randomization and 15 days after randomization
Number of total Lymphocytes T
Number of total LT (using immuno-phenotyping) will explore the immune response
Measured: On day 0 before randomization and 15 days after randomization
Number of CD3+ Lymphocytes T(lymphocyte subpopulation of CD3+ T cells)
Number of CD3+ LT (using immuno-phenotyping) will explore the immune response
Measured: On day 0 before randomization and 15 days after randomization
Number of CD4+ Lymphocytes T(lymphocyte subpopulation of CD4+ T cells)
Number of total CD4+ LT (using immuno-phenotyping) will explore the immune response
Measured: On day 0 before randomization and 15 days after randomization
Number of CD8+ Lymphocytes T(lymphocyte subpopulation of CD8+ T cells)
Evaluation of number of CD8+ LT (using immuno-phenotyping) will explore the immune response
Measured: On day 0 before randomization and 15 days after randomization
Interleukin 6 (IL-6)
Systemic concentration measurement of IL-6 will explore the inflammatory response
Measured: On day 0 before randomization and 15 days after randomization
Interleukin 10 (IL-10)
Systemic concentration measurement of IL-10 will explore the inflammatory response
Measured: On day 0 before randomization and 15 days after randomization
Tumor Necrosis Factor alpha (TNFα )
Systemic concentration measurement of TNFα will explore the inflammatory response
Measured: On day 0 before randomization and 15 days after randomization
Interferon gamma (IFNγ)
Systemic concentration measurement of IFNγ will explore the inflammatory response
Measured: On day 0 before randomization and 15 days after randomization
Type I Interferon (type I IFN)
Systemic concentration measurement of type I IFN will explore the inflammatory response
Measured: On day 0 before randomization and 15 days after randomization
Tim3 expression
Evaluation of Tim3 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
PD1 expression
Evaluation of PD1 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
PD-L1 expression
Measurement of PD-L1 expression on monocytes will explore explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Human Leukocyte Antigen - DR isotype gene expression (HLA-DR expression)
Measurement of HLA-DR expression on monocytes will explore explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Production of IFNγ by lymphocytes T
The cytotoxic LT production of IFNγ will explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Production of granzyme B by lymphocytesT
The cytotoxic LT production of granzyme B will explore the fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Lipopolysaccharides (LPS)
Measurement of LPS will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
LBP(LPS-Binding Protein)
Measurement of LBP (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
sCD14
Measurement of sCD14 (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
High Density Lipoproteins
Measurement of High Density Lipoproteins proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Apolipoprotein
Measurement of apolipoprotein proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19
Measured: On day 0 before randomization and 15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, COVID-19 InfectionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413838
- Sponsor's protocol ID
- 69HCL20_0478
- Acronym
- NIVISCO
- Status last verified
- May 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04413838
- Acronym / sponsor ID
- NIVISCO / 69HCL20_0478
- Conditions
- Obesity, COVID-19 Infection
- Keywords
- COVID-19, Obesity, Nivolumab, Immunotherapy, Anti-PD1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 4 Jun 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.
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus).
Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19.
In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production.
This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIVOLUMAB on top of routine standard of care | Experimental | Drug: NIVOLUMABThis correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND aspartate aminotransferase (AST) > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a NIVOLUMAB treatment and routine standard of care for COVID-19 infection at the time of study inclusion |
| Standard of care for COVID-19 infection | Other | Other: Routine standard of careThis correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND AST > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a routine standard of care for COVID-19 infection at the time of study inclusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients between 18 and 70 years old
- COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2)
- Hospitalized patients
- Obese individuals (BMI≥30kg/m²)
- Lymphocyte counts between 500 and 1500/mm3.
Key exclusion criteria (22 listed)
- CRITERIA LINKED TO THE DISEASE SEVERITY :
- Patients currently treated for cancer or with personal history of cancer within the last 3 years.
- Patients with Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 and 4 stages).
- Chronic respiratory insufficiency treated with oxygen.
- Patients aged above 70 years old.
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 |
|---|---|---|
| NIVOLUMABIV injection within 30 minutes of 24ml file (=240 mg) containing NIVOLUMAB BMS(Bristol-Myers Squibb) 10mg/ml (immune check point inhibitor targeting PD-1) on top of routine standard of care for COVID-19 infection | Drug | NIVOLUMAB on top of routine standard of care |
| Routine standard of careNo intervention is planned in this arm. Patients will follow routine standard of care for the COVID-19 treatment | Other | Standard of care for COVID-19 infection |
Primary outcome
Patient's clinical state
Time frame: 15 days after randomization
Patient's clinical state will be evaluated by the proportion of patients able to be weaned of oxygen at D15 after randomization (randomization date is the day where the experimental treatment (i.e. NIVOLUMAB) is administered).
28 secondary outcomes
Readmission
Time frame: 7 days and 15 days after randomization
Mortality
Time frame: 7 days and 15 days after randomization
Oxygen flow needs
Time frame: 7 days after randomization
Requirement of oxygen
Time frame: 7 days and 15 days after randomization
Discharge from hospital
Time frame: 7 days and 15 days after randomization
Adverse events
Time frame: Within 15 days post-randomization and 90 days and 6 months after randomization
Presence of nasopharyngeal SARS-CoV-2
Time frame: On day 0 before randomization and 15 days after randomization
nasopharyngeal SARS-CoV-2 viral charge
Time frame: On day 0 before randomization and 15 days after randomization
Number of total Lymphocytes T
Time frame: On day 0 before randomization and 15 days after randomization
Number of CD3+ Lymphocytes T(lymphocyte subpopulation of CD3+ T cells)
Time frame: On day 0 before randomization and 15 days after randomization
Number of CD4+ Lymphocytes T(lymphocyte subpopulation of CD4+ T cells)
Time frame: On day 0 before randomization and 15 days after randomization
Number of CD8+ Lymphocytes T(lymphocyte subpopulation of CD8+ T cells)
Time frame: On day 0 before randomization and 15 days after randomization
Interleukin 6 (IL-6)
Time frame: On day 0 before randomization and 15 days after randomization
Interleukin 10 (IL-10)
Time frame: On day 0 before randomization and 15 days after randomization
Tumor Necrosis Factor alpha (TNFα )
Time frame: On day 0 before randomization and 15 days after randomization
Interferon gamma (IFNγ)
Time frame: On day 0 before randomization and 15 days after randomization
Type I Interferon (type I IFN)
Time frame: On day 0 before randomization and 15 days after randomization
Tim3 expression
Time frame: On day 0 before randomization and 15 days after randomization
PD1 expression
Time frame: On day 0 before randomization and 15 days after randomization
PD-L1 expression
Time frame: On day 0 before randomization and 15 days after randomization
Human Leukocyte Antigen - DR isotype gene expression (HLA-DR expression)
Time frame: On day 0 before randomization and 15 days after randomization
Production of IFNγ by lymphocytes T
Time frame: On day 0 before randomization and 15 days after randomization
Production of granzyme B by lymphocytesT
Time frame: On day 0 before randomization and 15 days after randomization
Lipopolysaccharides (LPS)
Time frame: On day 0 before randomization and 15 days after randomization
LBP(LPS-Binding Protein)
Time frame: On day 0 before randomization and 15 days after randomization
sCD14
Time frame: On day 0 before randomization and 15 days after randomization
High Density Lipoproteins
Time frame: On day 0 before randomization and 15 days after randomization
Apolipoprotein
Time frame: On day 0 before randomization and 15 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NIVOLUMAB in people with Obesity, COVID-19 Infection, 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 11 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel DISSE, Pr (+33 4 78 86 14 84, emmanuel.disse@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's clinical state (time frame: 15 days after randomization). 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 4 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.