Multiple SclerosisNCT04796584
Efficacy of COVID-19 Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication
An observational study of Multiple Sclerosis, run by Providence Health & Services at 1 site in United States.
Trial summary
The primary objective is to determine whether the use of immunomodulating medications have an impact on the ability to mount and sustain an immune response to SARS-CoV-2 spike protein following mRNA vaccination in patients with MS when compared to healthy controls not receiving immunomodulating medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 25 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There is no available information on whether patients being treated with immunomodulating agents will mount a response to SARS-CoV-2 vaccination comparable to that observed in the general population. Volunteers will be recruited from the MS patient population cared for at the Providence MS Center. Patients will be identified by review of electronic medical records. Patients who appear to meet the eligibility criteria will be contacted by an investigator and/or a delegated research staff member.
Who may be able to join
- Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able to provide informed consent in English
- Male or female, between the ages of 18 and 65 years inclusive at time of consent
- Meet one of the following:
- Plan to receive one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations within 30 days of the screening visit
- Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations, their first vaccine injection having occurred 45±7 days prior to the screening visit
- Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations, their first vaccine injection having occurred 90±7 days prior to the screening visit
- Meet the criteria of one of the four groups at the time of consent:
- Group 1: Diagnosed with multiple sclerosis and currently being treated with a stable dose of ocrelizumab, for 6 months or longer Group 2: Diagnosed with multiple sclerosis and currently being treated with a stable dose of fingolimod, for 6 months or longer Group 3: Diagnosed with multiple sclerosis and currently being treated with a stable dose of natalizumab, for 6 months or longer Group 4: Diagnosed with multiple sclerosis and currently being treated with a stable dose of dimethyl fumarate or diroximel fumarate, for 6 months or longer
Who cannot join
- 1. Subjects who have a BMI of >35.0 will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Neurological Specialties West
Portland, Oregon, 97225
About this study
Official title: Efficacy of COVID 19 SARS-CoV-2 mRNA Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication (SARSmRNA_MS)
The primary objective is to determine whether the use of immunomodulating medications have an impact on the ability to mount and sustain an immune response to SARS-CoV-2 spike protein following mRNA vaccination in patients with MS when compared to healthy controls not receiving immunomodulating medications.
We hypothesize that the use of immunomodulators in MS patients may eliminate or reduce the level of protective immune response, and/or shorten the duration of the protective response.
Read the detailed description
Analysis of cell-mediated and antibody-mediated immunity to the COVID-19, SARS-CoV-2 virus following treatment with mRNA vaccine, in patients with multiple sclerosis (MS) who are treated with immune modulating medication. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before their first vaccine injection (those who meet inclusion 3a only), 45 (those who meet inclusion 3a or 3b), 90 and 180 days after the first vaccine injection (those who meet inclusion 3a, 3b, or 3c). If they receive a booster vaccine injection, they will also be asked to provide 30 mL of whole blood 28-42 days after the booster injection date. These samples, obtained at Providence St. Vincent Medical Center, will be transferred to the Laboratory of Molecular and Tumor Immunology at the Earle A. Chiles Cancer Research Institute, where the blood will be processed and cryopreserved. Serum samples will be analyzed for the presence and titer of neutralizing antibodies to the SARS-CoV-2 virus. Isolated peripheral blood lymphocytes will be used for analyses of T cell responses to SARS-CoV-2 spike peptides. Responses will be compared to the immune responses of 10 subjects who have been enrolled in the CORVax spike plasmid DNA vaccine study and are subsequently referred to in this protocol as "healthy controls." The unused portion of the samples will be stored for future deep cytokine and genomic analyses if funding becomes available to perform these latter studies.
This study will include 4 cohorts, each will enroll 10 subjects who are being treated with an immunomodulating therapy for MS. The 4 immunomodulating medications selected, because each differs in their mechanisms of action, include ocrelizumab (B-cell lytic), fingolimod (prevents mobilization of B and T cells from peripheral lymphoid organs), natalizumab (blocks transmigration of monocytes, and lymphocytes into the central nervous system), and dimethyl fumarate/diroximel fumarate (reduces inflammation-induce oxidative stress).
- Conditions
- Multiple Sclerosis
- Being tested
- Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus
- Keywords
- mRNA-based SARS-CoV-2 vaccination
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusOther
mRNA vaccination for SARS-CoV-2 is not provided by the study
| Study group | Role | What they receive |
|---|---|---|
| MS subjects who are being treated with ocrelizumab | Ocrelizumab's immunomodulating mechanisms of action is B-cell lytic. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). Receives: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus | |
| MS subjects who are being treated with fingolimod | Fingolimod's immunomodulating mechanisms of action is to prevent mobilization of B and T cells from peripheral lymphoid organs. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). Receives: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus | |
| MS subjects who are being treated with natalizumab | Natalizumab's immunomodulating mechanisms of action is to block transmigration of monocytes, and lymphocytes into the central nervous system. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). Receives: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus | |
| MS subjects who are being treated with dimethyl fumarate/diroximel fumarate | Dimethyl Fumarate's immunomodulating mechanisms of action is to reduce inflammation-induced oxidative stress. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). Receives: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer of antibody against SARS-CoV-2 spike protein
Serum Sample
Measured: Day 45 following initial vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: Day 45 following initial vaccination
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: Day 45 following initial vaccination
Secondary outcomes (8)
Titer of antibody against SARS-CoV-2 spike protein
Serum Sample
Measured: Day 90 following initial vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: Day 90 following initial vaccination
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: Day 90 following initial vaccination
Titer of antibody against SARS-CoV-2 spike protein
Serum Sample
Measured: Day 180 following initial vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: Day 180 following initial vaccination
Titer of antibody against SARS-CoV-2 spike protein
Serum Sample
Measured: 28-42 days following booster vaccination
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: 28-42 days following booster vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Serum Sample
Measured: 28-42 days following booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start11 Jul 2022
- Primary completion4 Oct 2022
- Study completion25 Oct 2022
Why it stopped: Enrollment paused for greater than 6 months, data would not be relevant as enrollment took longer than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Cohan, MD PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796584
- Sponsor's protocol ID
- SARSmRNA_MS
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be kept in secure computer files, in locked research offices that are both only accessible to research personnel, and in a secure password protected Clinical Trial Management System (CTMS). Publications or presentations will report aggregate data and will not contain any subject identification.
Publications
Kataria S, Tandon M, Melnic V, Sriwastava S. A case series and literature review of multiple sclerosis and COVID-19: Clinical characteristics, outcomes and a brief review of immunotherapies. eNeurologicalSci. 2020 Dec;21:100287. doi: 10.1016/j.ensci.2020.100287. Epub 2020 Nov 2.
PubMed 33163634Mohn N, Konen FF, Pul R, Kleinschnitz C, Pruss H, Witte T, Stangel M, Skripuletz T. Experience in Multiple Sclerosis Patients with COVID-19 and Disease-Modifying Therapies: A Review of 873 Published Cases. J Clin Med. 2020 Dec 16;9(12):4067. doi: 10.3390/jcm9124067.
PubMed 33339436Sormani MP; Italian Study Group on COVID-19 infection in multiple sclerosis. An Italian programme for COVID-19 infection in multiple sclerosis. Lancet Neurol. 2020 Jun;19(6):481-482. doi: 10.1016/S1474-4422(20)30147-2. Epub 2020 Apr 30. No abstract available.
PubMed 32359409Louapre C, Collongues N, Stankoff B, Giannesini C, Papeix C, Bensa C, Deschamps R, Creange A, Wahab A, Pelletier J, Heinzlef O, Labauge P, Guilloton L, Ahle G, Goudot M, Bigaut K, Laplaud DA, Vukusic S, Lubetzki C, De Seze J; Covisep investigators; Derouiche F, Tourbah A, Mathey G, Theaudin M, Sellal F, Dugay MH, Zephir H, Vermersch P, Durand-Dubief F, Francoise R, Androdias-Condemine G, Pique J, Codjia P, Tilikete C, Marcaud V, Lebrun-Frenay C, Cohen M, Ungureanu A, Maillart E, Beigneux Y, Roux T, Corvol JC, Bordet A, Mathieu Y, Le Breton F, Boulos DD, Gout O, Gueguen A, Moulignier A, Boudot M, Chardain A, Coulette S, Manchon E, Ayache SS, Moreau T, Garcia PY, Kumaran D, Castelnovo G, Thouvenot E, Taithe F, Poupart J, Kwiatkowski A, Defer G, Derache N, Branger P, Biotti D, Ciron J, Clerc C, Vaillant M, Magy L, Montcuquet A, Kerschen P, Coustans M, Guennoc AM, Brochet B, Ouallet JC, Ruet A, Dulau C, Wiertlewski S, Berger E, Buch D, Bourre B, Pallix-Guiot M, Maurousset A, Audoin B, Rico A, Maarouf A, Edan G, Papassin J, Videt D. Clinical Characteristics and Outcomes in Patients With Coronavirus Disease 2019 and Multiple Sclerosis. JAMA Neurol. 2020 Sep 1;77(9):1079-1088. doi: 10.1001/jamaneurol.2020.2581.
PubMed 32589189
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of COVID 19 SARS-CoV-2 mRNA Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication (SARSmRNA_MS)
- ClinicalTrials.gov ID
- NCT04796584
- Acronym / sponsor ID
- SARSmRNA_MS
- Conditions
- Multiple Sclerosis
- Keywords
- mRNA-based SARS-CoV-2 vaccination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment paused for greater than 6 months, data would not be relevant as enrollment took longer than expected.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 15 Mar 2021 (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 primary objective is to determine whether the use of immunomodulating medications have an impact on the ability to mount and sustain an immune response to SARS-CoV-2 spike protein following mRNA vaccination in patients with MS when compared to healthy controls not receiving immunomodulating medications.
We hypothesize that the use of immunomodulators in MS patients may eliminate or reduce the level of protective immune response, and/or shorten the duration of the protective response.
Detailed description
Analysis of cell-mediated and antibody-mediated immunity to the COVID-19, SARS-CoV-2 virus following treatment with mRNA vaccine, in patients with multiple sclerosis (MS) who are treated with immune modulating medication. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before their first vaccine injection (those who meet inclusion 3a only), 45 (those who meet inclusion 3a or 3b), 90 and 180 days after the first vaccine injection (those who meet inclusion 3a, 3b, or 3c). If they receive a booster vaccine injection, they will also be asked to provide 30 mL of whole blood 28-42 days after the booster injection date. These samples, obtained at Providence St. Vincent Medical Center, will be transferred to the Laboratory of Molecular and Tumor Immunology at the Earle A. Chiles Cancer Research Institute, where the blood will be processed and cryopreserved. Serum samples will be analyzed for the presence and titer of neutralizing antibodies to the SARS-CoV-2 virus. Isolated peripheral blood lymphocytes will be used for analyses of T cell responses to SARS-CoV-2 spike peptides. Responses will be compared to the immune responses of 10 subjects who have been enrolled in the CORVax spike plasmid DNA vaccine study and are subsequently referred to in this protocol as "healthy controls." The unused portion of the samples will be stored for future deep cytokine and genomic analyses if funding becomes available to perform these latter studies.
This study will include 4 cohorts, each will enroll 10 subjects who are being treated with an immunomodulating therapy for MS. The 4 immunomodulating medications selected, because each differs in their mechanisms of action, include ocrelizumab (B-cell lytic), fingolimod (prevents mobilization of B and T cells from peripheral lymphoid organs), natalizumab (blocks transmigration of monocytes, and lymphocytes into the central nervous system), and dimethyl fumarate/diroximel fumarate (reduces inflammation-induce oxidative stress).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS subjects who are being treated with ocrelizumab | – | Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusOcrelizumab's immunomodulating mechanisms of action is B-cell lytic. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). |
| MS subjects who are being treated with fingolimod | – | Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusFingolimod's immunomodulating mechanisms of action is to prevent mobilization of B and T cells from peripheral lymphoid organs. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). |
| MS subjects who are being treated with natalizumab | – | Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusNatalizumab's immunomodulating mechanisms of action is to block transmigration of monocytes, and lymphocytes into the central nervous system. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). |
| MS subjects who are being treated with dimethyl fumarate/diroximel fumarate | – | Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusDimethyl Fumarate's immunomodulating mechanisms of action is to reduce inflammation-induced oxidative stress. Each consenting subject will provide approximately 30 mL of whole blood via venipuncture before and 45, 90 and 180 days after the first vaccine injection and 28-42 days after the booster vaccination (if applicable). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There is no available information on whether patients being treated with immunomodulating agents will mount a response to SARS-CoV-2 vaccination comparable to that observed in the general population. Volunteers will be recruited from the MS patient population cared for at the Providence MS Center. Patients will be identified by review of electronic medical records. Patients who appear to meet the eligibility criteria will be contacted by an investigator and/or a delegated research staff member.
Key inclusion criteria (8 listed)
- Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able to provide informed consent in English
- Male or female, between the ages of 18 and 65 years inclusive at time of consent
- Meet one of the following:
- Meet the criteria of one of the four groups at the time of consent:
- Group 1: Diagnosed with multiple sclerosis and currently being treated with a stable dose of ocrelizumab, for 6 months or longer Group 2: Diagnosed with multiple sclerosis and currently being treated with a stable dose of fingolimod, for 6 months or longer Group 3: Diagnosed with multiple sclerosis and currently being treated with a stable dose of natalizumab, for 6 months or longer Group 4: Diagnosed with multiple sclerosis and currently being treated with a stable dose of dimethyl fumarate or diroximel fumarate, for 6 months or longer
Key exclusion criteria (1 listed)
- 1. Subjects who have a BMI of >35.0 will be excluded
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 |
|---|---|---|
| Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusmRNA vaccination for SARS-CoV-2 is not provided by the study | Other | MS subjects who are being treated with dimethyl fumarate/diroximel fumarate, MS subjects who are being treated with fingolimod, MS subjects who are being treated with natalizumab, MS subjects who are being treated with ocrelizumab |
Primary outcome
Titer of antibody against SARS-CoV-2 spike protein
Time frame: Day 45 following initial vaccination
Serum Sample
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: Day 45 following initial vaccination
Serum Sample
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: Day 45 following initial vaccination
Serum Sample
8 secondary outcomes
Titer of antibody against SARS-CoV-2 spike protein
Time frame: Day 90 following initial vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: Day 90 following initial vaccination
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: Day 90 following initial vaccination
Titer of antibody against SARS-CoV-2 spike protein
Time frame: Day 180 following initial vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: Day 180 following initial vaccination
Titer of antibody against SARS-CoV-2 spike protein
Time frame: 28-42 days following booster vaccination
Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: 28-42 days following booster vaccination
Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein
Time frame: 28-42 days following booster vaccination
Results and safety
The study was stopped early (reason given: Enrollment paused for greater than 6 months, data would not be relevant as enrollment took longer than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 33163634Kataria S, Tandon M, Melnic V, Sriwastava S. A case series and literature review of multiple sclerosis and COVID-19: Clinical characteristics, outcomes and a brief review of immunotherapies. eNeurologicalSci. 2020 Dec;21:100287. doi: 10.1016/j.ensci.2020.100287. Epub 2020 Nov 2.
- Background: PubMed 33339436Mohn N, Konen FF, Pul R, Kleinschnitz C, Pruss H, Witte T, Stangel M, Skripuletz T. Experience in Multiple Sclerosis Patients with COVID-19 and Disease-Modifying Therapies: A Review of 873 Published Cases. J Clin Med. 2020 Dec 16;9(12):4067. doi: 10.3390/jcm9124067.
- Background: PubMed 32359409Sormani MP; Italian Study Group on COVID-19 infection in multiple sclerosis. An Italian programme for COVID-19 infection in multiple sclerosis. Lancet Neurol. 2020 Jun;19(6):481-482. doi: 10.1016/S1474-4422(20)30147-2. Epub 2020 Apr 30. No abstract available.
- Background: PubMed 32589189Louapre C, Collongues N, Stankoff B, Giannesini C, Papeix C, Bensa C, Deschamps R, Creange A, Wahab A, Pelletier J, Heinzlef O, Labauge P, Guilloton L, Ahle G, Goudot M, Bigaut K, Laplaud DA, Vukusic S, Lubetzki C, De Seze J; Covisep investigators; Derouiche F, Tourbah A, Mathey G, Theaudin M, Sellal F, Dugay MH, Zephir H, Vermersch P, Durand-Dubief F, Francoise R, Androdias-Condemine G, Pique J, Codjia P, Tilikete C, Marcaud V, Lebrun-Frenay C, Cohen M, Ungureanu A, Maillart E, Beigneux Y, Roux T, Corvol JC, Bordet A, Mathieu Y, Le Breton F, Boulos DD, Gout O, Gueguen A, Moulignier A, Boudot M, Chardain A, Coulette S, Manchon E, Ayache SS, Moreau T, Garcia PY, Kumaran D, Castelnovo G, Thouvenot E, Taithe F, Poupart J, Kwiatkowski A, Defer G, Derache N, Branger P, Biotti D, Ciron J, Clerc C, Vaillant M, Magy L, Montcuquet A, Kerschen P, Coustans M, Guennoc AM, Brochet B, Ouallet JC, Ruet A, Dulau C, Wiertlewski S, Berger E, Buch D, Bourre B, Pallix-Guiot M, Maurousset A, Audoin B, Rico A, Maarouf A, Edan G, Papassin J, Videt D. Clinical Characteristics and Outcomes in Patients With Coronavirus Disease 2019 and Multiple Sclerosis. JAMA Neurol. 2020 Sep 1;77(9):1079-1088. doi: 10.1001/jamaneurol.2020.2581.
- Individual participant dataSharing planned: No. Study data will be kept in secure computer files, in locked research offices that are both only accessible to research personnel, and in a secure password protected Clinical Trial Management System (CTMS). Publications or presentations will report aggregate data and will not contain any subject identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Cohan, MD PhD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Providence Health & Services at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 3 Apr 2023. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment paused for greater than 6 months, data would not be relevant as enrollment took longer than expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titer of antibody against SARS-CoV-2 spike protein (time frame: Day 45 following initial vaccination). The study lists 3 primary outcomes in all. 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 NCT04796584, which also lists 4 linked publications.
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 3 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.