COVID-19CLEARNCT05917951
Study on Determine the Utilisation and Clinical Outcomes of Evusheld in COVID-19 PrEP in China
An observational study of COVID-19, run by AstraZeneca at 1 site in China.
Trial summary
Evusheld(AZD7442) is a combination of 2 human long-acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2022to 20 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants included in this this study are all individuals who have received AZD7442 since AZD7442 will be on market in China.
Who may be able to join
- Subjects who fulfil all the following inclusion criteria will be eligible to participate in the study:
- Individuals receiving AZD7442 before enrolment date or have been prescribed or have planned to administrate at enrolment date.
- Individuals willing and able to sign informed consent signed.
Who cannot join
- Subjects who fulfil any of the following exclusion criteria will not be eligible to participate in the study:
- Individuals currently participating in interventional clinical trials of SARS-CoV-2 prophylactic or treatments.
Trial locations and contacts
1 site in 1 country.
China1 site
(2) Ruijin-Hainan Hospital Shanghai Jiaotong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan
About this study
Official title: Study on Clinical Use of Evusheld (AZD7442) in the Real-world Setting - A Multi-Centre, Single-arm, Observational Study to Determine the Utilisation and Clinical Outcomes of Evusheld in China
Evusheld(AZD7442) is a combination of 2 human long-acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure to SARS-CoV-2 or both. The study met the primary endpoint of reduction in the incidence of symptomatic Coronavirus disease 2019 (COVID-19) with tixagevimab/cilgavimab (TIXA/CILGA) compared with placebo, risk reduction 76.7% (95% CI, 46.0-90.0), in 5172 patients who did not have a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 infection at baseline. Although the PROVENT trial was invaluable in demonstrating AZD7442's ability to prevent symptomatic infection, it was conducted in highly controlled environments using a rigorous protocol, which does not accurately reflect the patient experience in clinical practice. Furthermore, the sample size of Asian population in phase 3 clinical trials is small (110 subjects in AZD7442 group and 60 subjects in placebo group), and there is very limited clinical trial/real-world data in Chinese population is reported. Therefore, this current study aims to describe the utilisation and clinical outcomes of AZD7442 in Chinese population for pre-exposure prophylaxis.
Read the detailed description
COVID-19 has a spectrum of clinical manifestations and multisystem organ involvement due to SARS-CoV-2, viral dynamics may correlate to the severity of illness and disease outcomes. Despite the increase in COVID-19 vaccine roll-out, many individuals still remain at high risk of breakthrough infection and many of these individuals are also at higher risk of poor COVID-19 outcomes. In the US about 3% of the adult population is moderately to severely immunocompromised, leading to increased vulnerability to COVID-19.
AZD7442 is a combination of 2 human long acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. AZD7442 are 2 monoclonal antibodies that independently neutralize SARS-CoV-2 with high potency in vitro. AZD7442 targets SARS-CoV-2 spike protein to prevent virus entry into host cells.
PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure to SARS-CoV-2 or both. The study met the primary endpoint of reduction in the incidence of symptomatic COVID-19 with TIXA/CILGA compared with placebo, risk reduction 76.7% (95% CI, 46.0-90.0), and longer (median 6-month) follow-up showed a risk reduction of 82.8%, in 5172 patients who did not have a SARS-CoV-2 RT-PCR-positive COVID-19 infection at baseline. Most adverse events were mild or moderate in intensity, with the overall adverse event profile over a median follow-up of 6 months remaining similar to the primary safety analysis. At either the primary or 6-month analyses, there were no cases of severe/critical COVID-19 in those treated with AZD7442. In the placebo arm, there were 5 cases of severe/critical COVID-19 in total.
Although the PROVENT trial was invaluable in demonstrating AZD7442's ability to prevent symptomatic infection, it was conducted in highly controlled environments using a rigorous protocol, which does not accurately reflect the patient experience in clinical practice. Furthermore, the sample size of Asian population in phase 3 clinical trials is small (110 subjects in AZD7442 group and 60 subjects in placebo group), and there is very limited clinical trial/real-world data in Chinese population is reported.
Studies are therefore needed to understand who is being administered AZD7442 in the real world, the frequency of COVID-19 related events, and healthcare resource utilisation (HCRU). Also, important to understand is the potential impact that AZD7442 administration may have on COVID-19 risk behaviours (particularly shielding and other preventive measures), which may in turn influence interpretation of AZD7442 effectiveness results. Such information is imperative to inform clinical decision-making for the care of this relatively vulnerable population.
Therefore, this current study aims to describe the utilisation and clinical outcomes of AZD7442 in Chinese population for pre-exposure prophylaxis. Although this study will not evaluate the effectiveness of AZD7442, the descriptive results may guide further development of studies to assess real world effectiveness of AZD7442. The study is planned to be conducted in approximately 100 sites in China.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
- Proportion of individuals by demographic variables of interest (e.g. age, gender, race/ethnicity, smoking status, weight(kg) and height(cm) will be combined to reported body mass index(BMI) in kg/m^2, cities of frequency travel and residence, long-term care or assisted living, household composition, high risk contacts)
- Proportion of individuals by clinical characteristics of interest (e.g. comorbidities, prior and concurrent medications, including immunosuppressors by type/class)
- Proportion of individuals by baseline COVID-19 vaccination status or any history of exposure to other prophylactic interventions for prevention of SARS-CoV-2 exposure.
- Proportion of individuals by baseline history of SARS-CoV-2 infection/COVID-19 diagnosis and disease severity.
- Proportion of individuals by priority AZD7442 subpopulations of interest
Measured: up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis
Secondary outcomes (6)
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis by population subgroup of key basic disease.
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis by population subgroup of immune compromised disease, including haematological malignancies, solid organ transplant, autoimmune disease, solid tumour, chronic kidney disease (CKD; including dialysis) and others
Measured: up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis
To describe the incidence of SARS-CoV-2 infection (asymptomatic or symptomatic), medically-attended COVID-19, and COVID-19 related hospitalization and death up to 6 months after first administrationxposure prophylaxis of AZD7442 for pre-e
- Medically attended COVID-19 rate
- SARS-CoV-2 infection rates (asymptomatic or symptomatic)
- Proportion of SARS-CoV-2 infection (asymptomatic or symptomatic) in close contacts
- Proportion of SARS-CoV-2 infection from different cities
- Type of COVID-19 Variant
- COVID-19 mortality rates
- COVID-19 hospitalisation rates
- COVID-19 intensive care unit (ICU) admission rates
Measured: 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe the incidence of all-cause hospitalization and mortality during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
- All cause hospitalisation rate
- All-cause mortality rate
Measured: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe COVID-19 risk behaviours at the time of AZD7442 injection and during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
- AstraZeneca-developed Risk Behaviour Questionnaire (Appendix A)
Measured: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe COVID-19-related healthcare resource utilisation (HCRU) during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
- Hospitalization, and days hospitalised
- Supplemental oxygen, and days under supplemental oxygen
- Re-admission, days in hospital
- ICU admissions and days in ICU
- Emergency department (ED) visits
- Outpatient visits/calls (specialist)
- COVID-19 related medications or treatment
- Others
Measured: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe the safety of AZD7442 during the 6 months after first administration of AZD7442
- Serious adverse events (SAEs)
- Adverse events of special interest (AESIs)
- Adverse drug reaction (ADR)
Measured: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start24 Dec 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
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 AstraZenecaThe 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
- Other
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieming Qu, Doctor, Principal investigator, 18917762988
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917951
- Sponsor's protocol ID
- D8850R00019
- Acronym
- CLEAR
- Status last verified
- May 2024
- First submitted
- 2 Dec 2022
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for Individual participant data(IPD), but this does not mean all requests will be shared.
Publications
You J, Wu H, Tian J, Wen J, Shi W, Wang Z, Du Y, Xu H, Wei H, Li X, Kang W, Zhou M, Gu Z, Qu J. Real-world clinical outcomes of tixagevimab/cilgavimab in the Omicron outbreak in China: baseline characteristics and interim analysis of the CLEAR study. Virol J. 2024 Oct 24;21(1):262. doi: 10.1186/s12985-024-02509-5.
PubMed 39448986
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Clinical Use of Evusheld (AZD7442) in the Real-world Setting - A Multi-Centre, Single-arm, Observational Study to Determine the Utilisation and Clinical Outcomes of Evusheld in China
- ClinicalTrials.gov ID
- NCT05917951
- Acronym / sponsor ID
- CLEAR / D8850R00019
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 26 Jun 2023 (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.
Evusheld(AZD7442) is a combination of 2 human long-acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure to SARS-CoV-2 or both. The study met the primary endpoint of reduction in the incidence of symptomatic Coronavirus disease 2019 (COVID-19) with tixagevimab/cilgavimab (TIXA/CILGA) compared with placebo, risk reduction 76.7% (95% CI, 46.0-90.0), in 5172 patients who did not have a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 infection at baseline. Although the PROVENT trial was invaluable in demonstrating AZD7442's ability to prevent symptomatic infection, it was conducted in highly controlled environments using a rigorous protocol, which does not accurately reflect the patient experience in clinical practice. Furthermore, the sample size of Asian population in phase 3 clinical trials is small (110 subjects in AZD7442 group and 60 subjects in placebo group), and there is very limited clinical trial/real-world data in Chinese population is reported. Therefore, this current study aims to describe the utilisation and clinical outcomes of AZD7442 in Chinese population for pre-exposure prophylaxis.
Detailed description
COVID-19 has a spectrum of clinical manifestations and multisystem organ involvement due to SARS-CoV-2, viral dynamics may correlate to the severity of illness and disease outcomes. Despite the increase in COVID-19 vaccine roll-out, many individuals still remain at high risk of breakthrough infection and many of these individuals are also at higher risk of poor COVID-19 outcomes. In the US about 3% of the adult population is moderately to severely immunocompromised, leading to increased vulnerability to COVID-19.
AZD7442 is a combination of 2 human long acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. AZD7442 are 2 monoclonal antibodies that independently neutralize SARS-CoV-2 with high potency in vitro. AZD7442 targets SARS-CoV-2 spike protein to prevent virus entry into host cells.
PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure to SARS-CoV-2 or both. The study met the primary endpoint of reduction in the incidence of symptomatic COVID-19 with TIXA/CILGA compared with placebo, risk reduction 76.7% (95% CI, 46.0-90.0), and longer (median 6-month) follow-up showed a risk reduction of 82.8%, in 5172 patients who did not have a SARS-CoV-2 RT-PCR-positive COVID-19 infection at baseline. Most adverse events were mild or moderate in intensity, with the overall adverse event profile over a median follow-up of 6 months remaining similar to the primary safety analysis. At either the primary or 6-month analyses, there were no cases of severe/critical COVID-19 in those treated with AZD7442. In the placebo arm, there were 5 cases of severe/critical COVID-19 in total.
Although the PROVENT trial was invaluable in demonstrating AZD7442's ability to prevent symptomatic infection, it was conducted in highly controlled environments using a rigorous protocol, which does not accurately reflect the patient experience in clinical practice. Furthermore, the sample size of Asian population in phase 3 clinical trials is small (110 subjects in AZD7442 group and 60 subjects in placebo group), and there is very limited clinical trial/real-world data in Chinese population is reported.
Studies are therefore needed to understand who is being administered AZD7442 in the real world, the frequency of COVID-19 related events, and healthcare resource utilisation (HCRU). Also, important to understand is the potential impact that AZD7442 administration may have on COVID-19 risk behaviours (particularly shielding and other preventive measures), which may in turn influence interpretation of AZD7442 effectiveness results. Such information is imperative to inform clinical decision-making for the care of this relatively vulnerable population.
Therefore, this current study aims to describe the utilisation and clinical outcomes of AZD7442 in Chinese population for pre-exposure prophylaxis. Although this study will not evaluate the effectiveness of AZD7442, the descriptive results may guide further development of studies to assess real world effectiveness of AZD7442. The study is planned to be conducted in approximately 100 sites in China.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants included in this this study are all individuals who have received AZD7442 since AZD7442 will be on market in China.
Key inclusion criteria (3 listed)
- Subjects who fulfil all the following inclusion criteria will be eligible to participate in the study:
- Individuals receiving AZD7442 before enrolment date or have been prescribed or have planned to administrate at enrolment date.
- Individuals willing and able to sign informed consent signed.
Key exclusion criteria (2 listed)
- Subjects who fulfil any of the following exclusion criteria will not be eligible to participate in the study:
- Individuals currently participating in interventional clinical trials of SARS-CoV-2 prophylactic or treatments.
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
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
Time frame: up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis
* Proportion of individuals by demographic variables of interest (e.g. age, gender, race/ethnicity, smoking status, weight(kg) and height(cm) will be combined to reported body mass index(BMI) in kg/m^2, cities of frequency travel and residence, long-term care or assisted living, household composition, high risk contacts) * Proportion of individuals by clinical characteristics of interest (e.g. comorbidities, prior and concurrent medications, including immunosuppressors by type/class) * Proportion of individuals by baseline COVID-19 vaccination status or any history of exposure to other prophylactic interventions for prevention of SARS-CoV-2 exposure. * Proportion of individuals by baseline history of SARS-CoV-2 infection/COVID-19 diagnosis and disease severity. * Proportion of individuals by priority AZD7442 subpopulations of interest
6 secondary outcomes
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis by population subgroup of key basic disease.
Time frame: up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis
To describe the incidence of SARS-CoV-2 infection (asymptomatic or symptomatic), medically-attended COVID-19, and COVID-19 related hospitalization and death up to 6 months after first administrationxposure prophylaxis of AZD7442 for pre-e
Time frame: 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe the incidence of all-cause hospitalization and mortality during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
Time frame: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe COVID-19 risk behaviours at the time of AZD7442 injection and during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
Time frame: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe COVID-19-related healthcare resource utilisation (HCRU) during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
Time frame: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
To describe the safety of AZD7442 during the 6 months after first administration of AZD7442
Time frame: during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis
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 May 2024.
- Derived from this study: PubMed 39448986You J, Wu H, Tian J, Wen J, Shi W, Wang Z, Du Y, Xu H, Wei H, Li X, Kang W, Zhou M, Gu Z, Qu J. Real-world clinical outcomes of tixagevimab/cilgavimab in the Omicron outbreak in China: baseline characteristics and interim analysis of the CLEAR study. Virol J. 2024 Oct 24;21(1):262. doi: 10.1186/s12985-024-02509-5.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for Individual participant data(IPD), but this does not mean all requests will be shared.
Related trials for COVID-19
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.
Jieming Qu, Doctor principal investigator
18917762988
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, run by AstraZeneca at 1 site in China.
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 3 inclusion and 2 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 May 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 China. 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?
To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis (time frame: up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis). 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 NCT05917951, 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 May 2024.