COVID-19PRECOVIMNCT05216588
Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies With Early Access Authorization in Immunocompromised Patients. A Prospective Cohort.
An observational study of COVID-19 and Immunocompromised Host, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Immunocompromised Host
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 31 Oct 2024
- 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: Patients who may be included in the cohort are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) or full market approval. In case of ATUc, patient are treated and monitored according to the Therapeutic Use Protocols specific for each ATU treatment defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.
Who may be able to join
- Adults (18 years-old or more)
- Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations
- qPCR negative at baseline
- SARS-CoV-2 RT-qPCR Negative at inclusion
- Patients who remain seronegative after a complete COVID-19 vaccination schedule
- Immunocompromised patients :
Show all 11Show fewer
- Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
- Life expectancy > 3 months
- Social security affiliation
- Lack of a legal protection measure
- Signed informed consent
Who cannot join
- Participation to another clinical study
- State medical aid
- Ongoing or scheduled plasmapheresis or immunoadsorption
- Pregnant / lactating woman
- Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection
- Hypersensitivity to one of the active substances or to one of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns
- Conditions
- COVID-19, Immunocompromised Host
- Keywords
- Post-Exposure Prophylaxis, Antibodies Monoclonal, Neutralizing Antibodies
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| EVUSHELD (tixagévimab/cilgavimab) 300 mg | Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 300mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. | |
| EVUSHELD (tixagévimab/cilgavimab) 600 mg | Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 600mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody activity
Measured: Month 1
Neutralizing antibody activity
Measured: Month 2
Neutralizing antibody activity
Measured: Month 3
Neutralizing antibody activity
Measured: Month 4
Neutralizing antibody activity
Measured: Month 5
Neutralizing antibody activity
Measured: Month 6
Neutralizing antibody activity
Measured: Month 9
Neutralizing antibody activity
Measured: Month 12
Secondary outcomes (55)
Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection
Measured: Month 12
Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period
Measured: Month 12
Proportion of patients infected with a resistant variant
Measured: Month 12
Proportion of patients with treatment AE
Measured: Month 12
Severity of treatment AE
Measured: Month 12
Proportion of patients with SAE
Measured: Month 12
Proportion of patients with suspended prophylaxis due to adverse event
Measured: Month 12
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 1
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 2
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 3
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 4
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 5
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 6
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 9
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Measured: Month 12
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 1
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 2
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 3
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 4
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 5
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 6
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 9
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Measured: Month 12
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 1
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 2
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 3
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 4
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 5
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 6
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 9
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Measured: Month 12
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 1
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 2
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 3
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 4
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 5
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 6
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 9
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Measured: Month 12
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 1
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 2
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 3
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 4
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 5
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 6
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 9
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Measured: Month 12
Anti-S et Anti- N antibodies levels
Measured: Month 1
Anti-S et Anti- N antibodies levels
Measured: Month 2
Anti-S et Anti- N antibodies levels
Measured: Month 3
Anti-S et Anti- N antibodies levels
Measured: Month 4
Anti-S et Anti- N antibodies levels
Measured: Month 5
Anti-S et Anti- N antibodies levels
Measured: Month 6
Anti-S et Anti- N antibodies levels
Measured: Month 9
Anti-S et Anti- N antibodies levels
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start26 Jan 2022
- Primary completion3 Nov 2023
- Study completion31 Oct 2024
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vincent LEVY, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216588
- Sponsor's protocol ID
- ANRS0166s PRECOVIM
- Other IDs
- 2021-006961-39
- Acronym
- PRECOVIM
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Lamballerie X, Martin-Blondel G, Dupont A, Izopet J, Mentre F, Kamar N, Autran B, Paintaud G, Caillard S, le Bourgeois A, Richez C, Couzi L, Xhaard A, Marjanovic Z, Avouac J, Jacquet C, Anglicheau D, Cheminant M, Yazdanpanah Y, Guyen SN, Terrier B, Gottenberg JE, Besson C, Letrou S, Kali S, Angoulvant D, Sanchez VP, Tardivon C, Blancho G, Levy V. Low serum neutralization of Omicron variants a month after AZD7442 prophylaxis initiation. J Infect. 2023 Jan;86(1):66-117. doi: 10.1016/j.jinf.2022.10.006. Epub 2022 Oct 8. No abstract available.
PubMed 36216187
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies With Early Access Authorization in Immunocompromised Patients. A Prospective Cohort.
- ClinicalTrials.gov ID
- NCT05216588
- Acronym / sponsor ID
- PRECOVIM / ANRS0166s PRECOVIM
- Conditions
- COVID-19, Immunocompromised Host
- Keywords
- Post-Exposure Prophylaxis, Antibodies Monoclonal, Neutralizing Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 31 Jan 2022 (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 prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVUSHELD (tixagévimab/cilgavimab) 300 mg | – | –Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 300mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. |
| EVUSHELD (tixagévimab/cilgavimab) 600 mg | – | –Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 600mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who may be included in the cohort are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) or full market approval. In case of ATUc, patient are treated and monitored according to the Therapeutic Use Protocols specific for each ATU treatment defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.
Key inclusion criteria (11 listed)
- Adults (18 years-old or more)
- Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations
- qPCR negative at baseline
- SARS-CoV-2 RT-qPCR Negative at inclusion
- Patients who remain seronegative after a complete COVID-19 vaccination schedule
Key exclusion criteria (6 listed)
- Participation to another clinical study
- State medical aid
- Ongoing or scheduled plasmapheresis or immunoadsorption
- Pregnant / lactating woman
- Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection
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
Neutralizing antibody activity
Time frame: Month 1
Neutralizing antibody activity
Time frame: Month 2
Neutralizing antibody activity
Time frame: Month 3
Neutralizing antibody activity
Time frame: Month 4
Neutralizing antibody activity
Time frame: Month 5
Neutralizing antibody activity
Time frame: Month 6
Neutralizing antibody activity
Time frame: Month 9
Neutralizing antibody activity
Time frame: Month 12
55 secondary outcomes
Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection
Time frame: Month 12
Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period
Time frame: Month 12
Proportion of patients infected with a resistant variant
Time frame: Month 12
Proportion of patients with treatment AE
Time frame: Month 12
Severity of treatment AE
Time frame: Month 12
Proportion of patients with SAE
Time frame: Month 12
Proportion of patients with suspended prophylaxis due to adverse event
Time frame: Month 12
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 1
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 2
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 3
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 4
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 5
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 6
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 9
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
Time frame: Month 12
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 1
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 2
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 3
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 4
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 5
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 6
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 9
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
Time frame: Month 12
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 1
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 2
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 3
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 4
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 5
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 6
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 9
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
Time frame: Month 12
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 1
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 2
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 3
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 4
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 5
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 6
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 9
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
Time frame: Month 12
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
Time frame: Month 1
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 29 Jan 2025.
- Results publication: PubMed 36216187de Lamballerie X, Martin-Blondel G, Dupont A, Izopet J, Mentre F, Kamar N, Autran B, Paintaud G, Caillard S, le Bourgeois A, Richez C, Couzi L, Xhaard A, Marjanovic Z, Avouac J, Jacquet C, Anglicheau D, Cheminant M, Yazdanpanah Y, Guyen SN, Terrier B, Gottenberg JE, Besson C, Letrou S, Kali S, Angoulvant D, Sanchez VP, Tardivon C, Blancho G, Levy V. Low serum neutralization of Omicron variants a month after AZD7442 prophylaxis initiation. J Infect. 2023 Jan;86(1):66-117. doi: 10.1016/j.jinf.2022.10.006. Epub 2022 Oct 8. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Vincent LEVY, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 COVID-19 and Immunocompromised Host, run by ANRS, Emerging Infectious Diseases 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 6 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 29 Jan 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 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.
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?
Neutralizing antibody activity (time frame: Month 1). The study lists 8 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 NCT05216588, 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 29 Jan 2025.