Multiple SclerosisNCT06460324
A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- Type of treatment
- Vaccines
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 3 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
- Fully vaccinated with any FDA-authorized COVID-19 vaccination.
- Diagnosed with MS.
- Receiving ofatumumab at the time of either (or both) of the following:
- Initial COVID-19 vaccination.
- Booster vaccination.
Show all 9Show fewer
- Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:
- Full COVID-19 vaccination course.
- Booster vaccine (among patients receiving ofatumumab at the time of the booster).
Who cannot join
- Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study
This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Vaccination Cohort | Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Measured: From 2 weeks up to 6 months post-vaccine
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.
Measured: From 2 weeks up to 6 months post-vaccine
Secondary outcomes (22)
Mean Age at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Gender at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Gender at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Race at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Race at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients per United States Region at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients per United States Region at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Time since MS Diagnosis at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Time since MS Diagnosis at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Secondary Progressive MS at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Primary Progressive MS at Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Number of Patients with Primary Progressive MS at Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Index date
Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Within 12 months preceding index date
Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Within 12 months preceding index date
Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Within 12 months preceding index date
Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.
Measured: Within 12 months preceding index date
Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:
- full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
- booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
- full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.
Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Measured: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.
Measured: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 May 2022
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460324
- Sponsor's protocol ID
- COMB157GUS27
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study
- ClinicalTrials.gov ID
- NCT06460324
- Acronym / sponsor ID
- COMB157GUS27
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 14 Jun 2024 (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.
This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccination Cohort | – | –Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (9 listed)
- Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
- Fully vaccinated with any FDA-authorized COVID-19 vaccination.
- Diagnosed with MS.
- Receiving ofatumumab at the time of either (or both) of the following:
- Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:
Key exclusion criteria (1 listed)
- Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status
Time frame: From 2 weeks up to 6 months post-vaccine
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)
Time frame: From 2 weeks up to 6 months post-vaccine
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.
22 secondary outcomes
Mean Age at Index Date by Vaccination Status
Time frame: Index date
Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)
Time frame: Index date
Gender at Index Date by Vaccination Status
Time frame: Index date
Gender at Index Date by Prior DMT
Time frame: Index date
Race at Index Date by Vaccination Status
Time frame: Index date
Race at Index Date by Prior DMT
Time frame: Index date
Number of Patients per United States Region at Index Date by Vaccination Status
Time frame: Index date
Number of Patients per United States Region at Index Date by Prior DMT
Time frame: Index date
Time since MS Diagnosis at Index Date by Vaccination Status
Time frame: Index date
Time since MS Diagnosis at Index Date by Prior DMT
Time frame: Index date
Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status
Time frame: Index date
Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT
Time frame: Index date
Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status
Time frame: Index date
Number of Patients with Secondary Progressive MS at Index Date by Prior DMT
Time frame: Index date
Number of Patients with Primary Progressive MS at Index Date by Vaccination Status
Time frame: Index date
Number of Patients with Primary Progressive MS at Index Date by Prior DMT
Time frame: Index date
Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status
Time frame: Within 12 months preceding index date
Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT
Time frame: Within 12 months preceding index date
Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status
Time frame: Within 12 months preceding index date
Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT
Time frame: Within 12 months preceding index date
Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status
Time frame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT
Time frame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Novartis Pharmaceuticals 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 9 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: finished, as of the sponsor's last update on 14 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status (time frame: From 2 weeks up to 6 months post-vaccine). The study lists 2 primary outcomes in all. 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 14 Jun 2024.