SARS-CoV-2 InfectionCo-StarsNCT04380896
COVID-19 Staff Testing of Antibody Responses Study (Co-Stars)
An observational study of SARS-CoV-2 Infection, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will perform prospective repeated serological antibody testing on a cohort of at least 1000 healthcare workers at Great Ormond Street Hospital. Within this cohort, a subset of 150-250 staff members with confirmed (PCR positive) SARS-CoV-2 disease will be followed with intensive monthly testing for 6 months… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Blood test and Standardised questionnaires
- How many people
- 3,502 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2020to 30 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will comprise frontline healthcare workers selected to be representative of all departments at Great Ormond Street Hospital. The researcher will ensure that equal numbers of men and women are recruited from each department and that age ranges are representative of the trust population age distribution.We will also check the age distribution of the participants on a weekly basis during recruitment against the known age distribution of the hospital to ensure that our sample is representative. If significant differences among ages between the study population and the hospital population age range emerge then we will actively recruit from those age ranges that we have inadequately sampled.
Inclusion Criteria for ARM 1: SARS-CoV-2 Seropositive Cases:
- Healthcare worker at GOSH
- >18 years of age
- ALL have confirmed detectable antibodies to SARS-CoV-2 infection on baseline screen
Then can be recruited into either of the following sub-groups
- Core Group of PCR Confirmed Cases : Must have symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive
- Other SARS-CoV-2 Sero-positives: May have Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases OR May have no symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases
Inclusion Criteria for ARM 2: SARS-CoV-2 Seronegative Comparison Group :
- Healthcare worker at GOSH
- >18 years of age
- ALL have confirmed negative antibodies to SARS-CoV-2 infection on baseline screen
Then can be recruited into either of the following Sub-groups:
- Core Comparison Group: Have not had clinical symptoms consistent with SARS-CoV-2 infection*
- Other Seronegatives: Have had symptoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days
- Clinical Symptoms for SARS-CoV-2 infection are defined as one of:
- New and persistent cough 2) Confirmed temperatures of 37.8 and above 3) Anosmia
General Exclusion Criteria :
- <18 years of age
- On immunosuppressive or immunomodulatory medication that may impact test reliability
- Received any blood product including immunoglobulins after October 2019
- Has received convalescent sera as treatment
- Current diagnosis of a malignancy that may impact test reliability
- Those lacking capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Staff Testing of Antibody Responses Study (CO-STARS)
This study will perform prospective repeated serological antibody testing on a cohort of at least 1000 healthcare workers at Great Ormond Street Hospital. Within this cohort, a subset of 150-250 staff members with confirmed (PCR positive) SARS-CoV-2 disease will be followed with intensive monthly testing for 6 months to determine whether antibody levels in the blood are maintained or decrease during this time. All 1000 recruited healthcare workers will be followed 6-monthly
Read the detailed description
A total of 250 healthcare workers are currently off sick with symptoms of SARS-CoV-2 infection (COVID-19) while 99 additional members of staff have been diagnosed with confirmed SARS-CoV-2 at Great Ormond Street Hospital. As a consequence, all routine surgery, out-patient activity and day cases have been postponed or cancelled altogether. It is therefore critical for us to understand whether or not this disease will continue to threaten staff health or whether natural infection will give rise to long lasting immunity.
This is a 2-arm prospective cohort study recruiting at least 1000 healthcare workers at GOSH over 6 years.Staff will be recruited and coordinated from each department to be representative of the full diversity of healthcare workers at the Trust. The age distribution of the participants will be monitored on a weekly, basis against the known age distribution of the hospital to ensure that the sample is representative.
Trust communications team will send an all staff email to inform them about this research project asking them to get in touch with the study team if they wish to participate and they meet the basic eligibility criteria. Potential participants will be asked voluntarily to attend a face to face appointment in person (or if preferred by telephone or 1:1 video teleconference meeting) to enable trained study staff to seek informed consent before they enter the study. Informed consent will be undertaken by study staff who are Good Clinical Practice trained, Human Tissue Act trained, study trained, GOSH consent trained and registered in the study log.
The consent process will specifically cover the reason for the study, the storage of samples and agreement for future samples to be tested once improved testing is made available. Once the member of staff has provided informed consent, they will be asked to undertake an online questionnaire in which they will record demographic details including age, sex, email address and telephone contact for results and coordinating follow up. The questionnaire will also record details of SARS-CoV-2 like symptoms, contact with SARS-CoV-2, pre-existing co-morbidities and medication or treatments that may interfere with serological testing.
After providing informed consent, the staff members then be asked attend the study phlebotomy testing clinic. Appointments will be 20 minutes in length but actual blood sampling for serological testing will be 5-10 minutes to allow plenty of time and space for staff members to be tested to maintain social distancing. A total of 8ml of blood will be stored for testing.
Follow up sampling and questionnaires of approximately 200 staff members with PCR confirmed SARS-CoV-2 infected staff will take place monthly. While follow up of all ~800 asymptomatic staff members will take place 6 monthly. All staff will continue to have access to the GOSH PCR COVID19 testing program (as they do at present). This will enable us to confirm with PCR testing any new (or reinfected) positive staff member with COVID-19 over the duration of the study.
When initially asymptomatic seronegative staff become serologically positive during the course of the study, they will remain under active surveillance but they will switch arms of the study and they will contribute to the active follow up of serologically positive patients.
If staff leave the GOSH NHS trust during the study they will still be eligible to remain in the study and be followed up and we will update their contact details on the follow-up questionnaire.
After the initial intensive phase, all approximately 1000 recruits will be followed 6 monthly for the 6 year duration of the study. Follow-up visits will be arranged following the baseline assessment. The same blood tests 4ml EDTA and 4ml serum will be taken at each follow up appointment as well as the same symptom questionnaire.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Blood test, Standardised questionnaires
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Blood tests (8ml in total) 4ml blood for serological testing (measure the antibody titres to the SARS-CoV-2 nucleo-capsid protein (4ml) and 4ml EDTA to be stored for future research will be taken for each group.
Standardised questionnairesOther
It will be an online questionnaire about staff members health, symptoms of SARS-CoV-2 and contact with SARS-CoV-2. All participants will also be asked to complete a detailed symptom and electronic questionnaire prior to each appointment.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Seropositive Cases | It will be formed of approximately N= 200 to 350 staff members
Core Group of PCR Confirmed Cases N ~ 150 to 250:
A) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive N ~ 150 to 250 OR
Other SARS-CoV-2 Sero-positives N ~ 50 to 100:
B) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases. OR C) No symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases Receives: Other: Blood test; Other: Standardised questionnaires | |
| SARS-CoV-2 Seronegative Comparison Group | It will be formed of approximately N= 800 to 900 staff members
Core Comparison Group N ~ 800 A) Have not had clinical symptoms consistent with SARS-CoV-2 infection OR
Other Seronegatives N ~ 100 B) Have had sympoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days Receives: Other: Blood test; Other: Standardised questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serial monthly log-transformed antibody titre levels as measured
To determine the kinetics (rate of change) of SARS-CoV-2 nucleo-capsid protein antibody titres in proven cases of SARS-CoV-2 over the 6 month period following infection
Measured: 6 months period post infection
Secondary outcomes (3)
Proportion of completely asymptomatic healthcare workers with evidence of SARS-CoV-2 antibodies
To determine the proportion of completely asymptomatic healthcare workers who have evidence of SARS-CoV-2 antibodies in their serum indicative of past infection
Measured: 12 months
The attack rate of SARS-CoV-2 in healthcare workers who have antibodies compared to those who do not
To determine the attack rate of SARS-CoV-2 in healthcare workers who have antibodies versus those who do not have antibodies
Measured: Betwen 3 to 6 years
The immune correlates of protection against future exposure to SARS-CoV-2
To determine the immune correlates of protection (Antibody Titres sufficient for protection) against future exposure to SARS-CoV-2
Measured: Between 3 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start27 Apr 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
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 SARS-CoV-2 InfectionStudies 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
- 3,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Grandjean, Dr, Principal investigator, Great Ormond Street Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380896
- Sponsor's protocol ID
- 20CB17
- Acronym
- Co-Stars
- Status last verified
- Sep 2022
- First submitted
- 4 May 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lam T, Saso A, Torres Ortiz A, Hatcher J, Woodman M, Chandran S, Thistlethwayte R, Best T, Johnson M, Wagstaffe H, Mai A, Buckland M, Gilmour K, Goldblatt D, Grandjean L; COVID-19 Staff Testing of Antibody Responses (Co-STARs) Study Team. Socioeconomic and Demographic Risk Factors for SARS-CoV-2 Seropositivity Among Healthcare Workers in a UK Hospital: A Prospective Cohort Study. Clin Infect Dis. 2024 Mar 20;78(3):594-602. doi: 10.1093/cid/ciad522.
PubMed 37647517Torres Ortiz A, Fenn Torrente F, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The influence of time on the sensitivity of SARS-CoV-2 serological testing. Sci Rep. 2022 Jun 22;12(1):10517. doi: 10.1038/s41598-022-14351-2.
PubMed 35732870Ortiz AT, Torrente FF, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The Influence of Time on the Sensitivity of SARS-CoV-2 Serological Testing. Res Sq [Preprint]. 2022 Feb 17:rs.3.rs-1286644. doi: 10.21203/rs.3.rs-1286644/v1.
PubMed 35194596Grandjean L, Saso A, Torres Ortiz A, Lam T, Hatcher J, Thistlethwayte R, Harris M, Best T, Johnson M, Wagstaffe H, Ralph E, Mai A, Colijn C, Breuer J, Buckland M, Gilmour K, Goldblatt D; COVID-19 Staff Testing of Antibody Responses Study (Co-Stars) team. Long-Term Persistence of Spike Protein Antibody and Predictive Modeling of Antibody Dynamics After Infection With Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2022 Apr 9;74(7):1220-1229. doi: 10.1093/cid/ciab607.
PubMed 34218284
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Staff Testing of Antibody Responses Study (CO-STARS)
- ClinicalTrials.gov ID
- NCT04380896
- Acronym / sponsor ID
- Co-Stars / 20CB17
- Conditions
- SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,502 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 8 May 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.
This study will perform prospective repeated serological antibody testing on a cohort of at least 1000 healthcare workers at Great Ormond Street Hospital. Within this cohort, a subset of 150-250 staff members with confirmed (PCR positive) SARS-CoV-2 disease will be followed with intensive monthly testing for 6 months to determine whether antibody levels in the blood are maintained or decrease during this time. All 1000 recruited healthcare workers will be followed 6-monthly
Detailed description
A total of 250 healthcare workers are currently off sick with symptoms of SARS-CoV-2 infection (COVID-19) while 99 additional members of staff have been diagnosed with confirmed SARS-CoV-2 at Great Ormond Street Hospital. As a consequence, all routine surgery, out-patient activity and day cases have been postponed or cancelled altogether. It is therefore critical for us to understand whether or not this disease will continue to threaten staff health or whether natural infection will give rise to long lasting immunity.
This is a 2-arm prospective cohort study recruiting at least 1000 healthcare workers at GOSH over 6 years.Staff will be recruited and coordinated from each department to be representative of the full diversity of healthcare workers at the Trust. The age distribution of the participants will be monitored on a weekly, basis against the known age distribution of the hospital to ensure that the sample is representative.
Trust communications team will send an all staff email to inform them about this research project asking them to get in touch with the study team if they wish to participate and they meet the basic eligibility criteria. Potential participants will be asked voluntarily to attend a face to face appointment in person (or if preferred by telephone or 1:1 video teleconference meeting) to enable trained study staff to seek informed consent before they enter the study. Informed consent will be undertaken by study staff who are Good Clinical Practice trained, Human Tissue Act trained, study trained, GOSH consent trained and registered in the study log.
The consent process will specifically cover the reason for the study, the storage of samples and agreement for future samples to be tested once improved testing is made available. Once the member of staff has provided informed consent, they will be asked to undertake an online questionnaire in which they will record demographic details including age, sex, email address and telephone contact for results and coordinating follow up. The questionnaire will also record details of SARS-CoV-2 like symptoms, contact with SARS-CoV-2, pre-existing co-morbidities and medication or treatments that may interfere with serological testing.
After providing informed consent, the staff members then be asked attend the study phlebotomy testing clinic. Appointments will be 20 minutes in length but actual blood sampling for serological testing will be 5-10 minutes to allow plenty of time and space for staff members to be tested to maintain social distancing. A total of 8ml of blood will be stored for testing.
Follow up sampling and questionnaires of approximately 200 staff members with PCR confirmed SARS-CoV-2 infected staff will take place monthly. While follow up of all ~800 asymptomatic staff members will take place 6 monthly. All staff will continue to have access to the GOSH PCR COVID19 testing program (as they do at present). This will enable us to confirm with PCR testing any new (or reinfected) positive staff member with COVID-19 over the duration of the study.
When initially asymptomatic seronegative staff become serologically positive during the course of the study, they will remain under active surveillance but they will switch arms of the study and they will contribute to the active follow up of serologically positive patients.
If staff leave the GOSH NHS trust during the study they will still be eligible to remain in the study and be followed up and we will update their contact details on the follow-up questionnaire.
After the initial intensive phase, all approximately 1000 recruits will be followed 6 monthly for the 6 year duration of the study. Follow-up visits will be arranged following the baseline assessment. The same blood tests 4ml EDTA and 4ml serum will be taken at each follow up appointment as well as the same symptom questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Seropositive Cases | – | Other: Blood test, Other: Standardised questionnairesIt will be formed of approximately N= 200 to 350 staff members Core Group of PCR Confirmed Cases N ~ 150 to 250: A) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive N ~ 150 to 250 OR Other SARS-CoV-2 Sero-positives N ~ 50 to 100: B) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases. OR C) No symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases |
| SARS-CoV-2 Seronegative Comparison Group | – | Other: Blood test, Other: Standardised questionnairesIt will be formed of approximately N= 800 to 900 staff members Core Comparison Group N ~ 800 A) Have not had clinical symptoms consistent with SARS-CoV-2 infection OR Other Seronegatives N ~ 100 B) Have had sympoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will comprise frontline healthcare workers selected to be representative of all departments at Great Ormond Street Hospital. The researcher will ensure that equal numbers of men and women are recruited from each department and that age ranges are representative of the trust population age distribution.We will also check the age distribution of the participants on a weekly basis during recruitment against the known age distribution of the hospital to ensure that our sample is representative. If significant differences among ages between the study population and the hospital population age range emerge then we will actively recruit from those age ranges that we have inadequately sampled.
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 |
|---|---|---|
| Blood testBlood tests (8ml in total) 4ml blood for serological testing (measure the antibody titres to the SARS-CoV-2 nucleo-capsid protein (4ml) and 4ml EDTA to be stored for future research will be taken for each group. | Other | SARS-CoV-2 Seronegative Comparison Group, SARS-CoV-2 Seropositive Cases |
| Standardised questionnairesIt will be an online questionnaire about staff members health, symptoms of SARS-CoV-2 and contact with SARS-CoV-2. All participants will also be asked to complete a detailed symptom and electronic questionnaire prior to each appointment. | Other | SARS-CoV-2 Seronegative Comparison Group, SARS-CoV-2 Seropositive Cases |
Primary outcome
Change in serial monthly log-transformed antibody titre levels as measured
Time frame: 6 months period post infection
To determine the kinetics (rate of change) of SARS-CoV-2 nucleo-capsid protein antibody titres in proven cases of SARS-CoV-2 over the 6 month period following infection
3 secondary outcomes
Proportion of completely asymptomatic healthcare workers with evidence of SARS-CoV-2 antibodies
Time frame: 12 months
The attack rate of SARS-CoV-2 in healthcare workers who have antibodies compared to those who do not
Time frame: Betwen 3 to 6 years
The immune correlates of protection against future exposure to SARS-CoV-2
Time frame: Between 3 to 6 years
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 27 Sep 2022.
- Derived from this study: PubMed 37647517Lam T, Saso A, Torres Ortiz A, Hatcher J, Woodman M, Chandran S, Thistlethwayte R, Best T, Johnson M, Wagstaffe H, Mai A, Buckland M, Gilmour K, Goldblatt D, Grandjean L; COVID-19 Staff Testing of Antibody Responses (Co-STARs) Study Team. Socioeconomic and Demographic Risk Factors for SARS-CoV-2 Seropositivity Among Healthcare Workers in a UK Hospital: A Prospective Cohort Study. Clin Infect Dis. 2024 Mar 20;78(3):594-602. doi: 10.1093/cid/ciad522.
- Derived from this study: PubMed 35732870Torres Ortiz A, Fenn Torrente F, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The influence of time on the sensitivity of SARS-CoV-2 serological testing. Sci Rep. 2022 Jun 22;12(1):10517. doi: 10.1038/s41598-022-14351-2.
- Derived from this study: PubMed 35194596Ortiz AT, Torrente FF, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The Influence of Time on the Sensitivity of SARS-CoV-2 Serological Testing. Res Sq [Preprint]. 2022 Feb 17:rs.3.rs-1286644. doi: 10.21203/rs.3.rs-1286644/v1.
- Derived from this study: PubMed 34218284Grandjean L, Saso A, Torres Ortiz A, Lam T, Hatcher J, Thistlethwayte R, Harris M, Best T, Johnson M, Wagstaffe H, Ralph E, Mai A, Colijn C, Breuer J, Buckland M, Gilmour K, Goldblatt D; COVID-19 Staff Testing of Antibody Responses Study (Co-Stars) team. Long-Term Persistence of Spike Protein Antibody and Predictive Modeling of Antibody Dynamics After Infection With Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2022 Apr 9;74(7):1220-1229. doi: 10.1093/cid/ciab607.
Related trials for SARS-CoV-2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Grandjean, Dr principal investigator
Great Ormond Street Hospital NHS Foundation Trust
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 SARS-CoV-2 Infection, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Sep 2022. 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 Kingdom. 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?
Change in serial monthly log-transformed antibody titre levels as measured (time frame: 6 months period post infection). 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 NCT04380896, 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 27 Sep 2022.