SARS-CoV-2 InfectionPhase 3NCT05438498
Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2
A Phase 3 study testing Evusheld (tixagevimab+cilgavimab) IM or IV in people with SARS-CoV-2 Infection, run by MediMergent, LLC at 40 sites in United States.
Trial summary
If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk for infection and its sequelae are significantly increased. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Evusheld (tixagevimab+cilgavimab) IM or IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 40 sitesUnited States
- Study dates
- 3 Jun 2022to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female gender at birth
- Age at least 18 years
- Women who are not pregnant, not breast feeding and of child bearing potential using contraception prior to enrollment in the study. Women of child bearing potential must agree to continued use of contraception throughout the 12 months of study participation.
- It is preferable that a patient has access to a "smartphone" or tablet or laptop or desktop computer and/or an email address
- In the event that a patient does not have access to any of the above, the patient may complete all follow-up surveys via the study's Call Center or in written form in the offices of the Principal Investigator as specified in the protocol
- Documented diagnosis of either hematologic malignancy or solid tumor as identified by standard ICD-10 diagnostic category
Show all 25Show fewer
- Patients may be included with any ONE of the following criteria:
- On active treatment for solid tumor or hematologic malignancies. This can include: high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), as well as any FDA-approved alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) or any combination of these agents
- Hematologic malignancy patients can also be included if he/she is up to 12 months post-treatment and either in remission, stable or progressing as determined by the Investigator
- Solid tumor patients can also be included if he/she is up to 6 months post-treatment
- Received chimeric antigen receptor (CAR-T) or hematopoietic stem cell transplant (within 1 year of transplantation or taking immunosuppression therapy)
- Cancer is progressing as determined by the Investigator
- Treatment must have been initiated ≤12 months prior to baseline for all patients,
- Concomitant radiation therapy is permitted but cannot be the sole therapy
- Have been vaccinated with one or more doses of Janssen, Moderna or Pfizer COVID-19 vaccine
- If having been previously diagnosed with SARS-CoV-2 infection, the diagnosis has to be at least 90 days prior to study randomization. If previously diagnosed, previous treatment with Ivermectin or hydroxychloroquine is acceptable.
- Have a negative SARS-CoV-2 antigen rapid test performed in the office at screening
- Patient willing to receive treatment with AZD7442 600 mg IM or IV
- Patient willing to complete baseline and 13 post-enrollment Patient Experience/Clinical Outcome Assessment surveys.
- Patient willing to complete baseline and 5 QoL assessments
- Patient willing to have blood drawn for serum concentration of AZD7442 9 times post-baseline and repeated if patient becomes COVID-19 positive
- Patient willing to have blood drawn for T-cell assay at day 30 post-baseline and repeated if patient becomes SARS-COV-2 RNA by RT-PCR positive
- Patient willing to have RBD-IgG drawn at baseline, days 90 and 180 post-baseline and repeated if patient becomes SARS-COV-2 RNA by RT-PCR positive
- Patient willing to signed Informed Consent Form
- Patient willing to sign Authorization for Release of Health Information (including treating physicians' or other medical personnel's records, medication prescriber records, pharmacy records and medical insurance claims)
Who cannot join
- Women who are pregnant, breast feeding or of child bearing potential and not using contraception
- Absence of a qualifying type of cancer as defined by standard ICD-10 diagnostic criteria
- Treatment initiated >12 months prior to baseline or were not on active therapy ≤12 months prior to enrollment with FDA approved oral, intramuscular and/or intravenous chemotherapy, immunotherapy, targeted therapy, other therapy or any combination of these agents
- Patient receiving only radiation therapy
- Patient with an ECOG performance status of 2 or higher
- Patient with an expected cancer survival of less than 12 months by disease category
Show all 31Show fewer
- Patient receiving adjuvant endocrine therapy as their only form of therapy for early-stage breast cancer
- Solid tumor patients more than 6 months post treatment and their cancer is considered to be stable or in remission as determined by the Investigator
- AZD7442 IM administration at any time prior to day of enrollment
- AZD7442 IM or IV administration on the same day as the patient receives any IV or IM cancer treatment
- Have a positive test for SARS-CoV-2 antigen performed by either Rapid Test or SARS-CoV-2 RNA by RT-PCR (Polymerase Chain Reaction) less than 90 days prior to enrollment
- Patient with a prior (within 90 days), current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any other EUA approved SARS-CoV-2 treatment
- Patient with fever >100.0 F, and/or cough, chills, loss of smell or taste or shortness of breath or any other signs or symptoms consistent with COVID-19 within 5 days prior to enrollment
- Patient who has any known active acute respiratory infection
- Patient who has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
- Patient who has a past SARS-CoV-2 infection within 90 days prior to randomization
- Patient who has received vaccination with any dose of Janssen, Pfizer or Moderna COVID-19 vaccine less than 14 days prior to baseline for this study
- Planned use of any investigational, authorized, or approved vaccine for COVID-19 less than 14 days prior to administration of AZD7442 600 mg IM or IV
- Patient who is unwilling to have SARS-CoV-2 RBD-IgG antibody levels drawn at least 3 times
- Patient who is unwilling to receive treatment with IM or IV AZD7442
- Patient who is unwilling to complete baseline and up to 13 follow-up Experience/Clinical Outcome Assessment (COA) surveys.
- Patient who is unwilling to complete baseline and up to 5 QoL assessments
- Patient who is unwilling to have blood drawn for AZD7442 serum concentration at least 9 times
- Patient who is unwilling to have blood drawn at least once for T-cell assay
- Patient whose native language is not English and does not have a person who can translate the regulatory documents, surveys and QoL assessments.
- Patient who is unable to provide Informed Consent or Authorization for Release of Health Information due to mental illness that requires a Legally Authorized Representative.
- Patient who is legally blind and does not have a witness/caregiver who has agreed to assist the patient in his/her participation in the study.
- Patient with a history of a severe allergic reaction (i.e., anaphylaxis) to any of the components of AZD7442
- Patient with a history of severe allergic reaction (hypersensitivity) to any SARS-COV-2 vaccination, Polyethylene Glycol (PEG) or Polysorbate 80
- Patient who is illiterate and does not have a witness/caregiver who has agreed to assist the patient in his/her participation in the study.
- Patient who is participating in an interventional trial for prophylaxis or treatment of SARS-CoV-2
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Maryland Oncology Hematology
Annapolis, Maryland, 21401
Mary Bird Perkins
Baton Rouge, Louisiana, 70809
Alliance Cancer Specialists
Bensalem, Pennsylvania, 19020
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Maryland Oncology Hematology
Bethesda, Maryland, 20817
Maryland Oncology Hematology
Brandywine, Maryland, 20613
New Jersey Center for Cancer Research
Brick, New Jersey, 08724
Consultants in Medical Oncology Hematology
Broomall, Pennsylvania, 19008
Gabrail Cancer Center
Canton, Ohio, 44718
Maryland Oncology Hematology
Columbia, Maryland, 21044
Zangmeister Cancer Center
Columbus, Ohio, 43219
Compassionate Cancer Care Medical Group
Corona, California, 92879
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Compassionate Care Medical Group
Fountain Valley, California, 92708
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, 17325
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
Southeastern Medical Oncology Center
Jacksonville, North Carolina, 28546
Alliance Cancer Specialists
Langhorne, Pennsylvania, 19047
Maryland Oncology Hematology
Lanham, Maryland, 20706
South Florida Cancer Care
Margate, Florida, 33063
Minniti Center for Oncology and Hematology
Mickleton, New Jersey, 08056
Tidelands Health Oncology
Murrells Inlet, South Carolina, 29576
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360
Florida Cancer Affiliates-Ocala
Ocala, Florida, 34474
Mid-Florida Hematology Oncology Center
Orange City, Florida, 32763
Ventura County Hematology Oncology
Oxnard, California, 93030
Alliance Cancer Specialists
Philadelphia, Pennsylvania, 19115
Compassionate Cancer Care Medical Group
Riverside, California, 92501
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
Maryland Oncology Hematology
Rockville, Maryland, 20850
Health Partners Institute-MMORC
Saint Louis Park, Minnesota, 55426
Cancer Center of Southern California
Santa Monica, California, 90403
Alliance Cancer Specialists
Sellersville, Pennsylvania, 18960
Maryland Oncology Hematology
Silver Spring, Maryland, 20904
Summit Cancer Centers
Spokane Valley, Washington, 99216
Oncology Hematology Associates
Springfield, Missouri, 65807
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Regional Medical Oncology Center
Wilson, North Carolina, 27893
Alliance Cancer Specialists
Wynnewood, Pennsylvania, 19096
About this study
Official title: Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2 Infection in Immuno-Suppressed Cancer Patients
If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk for infection and its sequelae are significantly increased. The Astra-Zeneca Immuno-Suppressed Program (AISP) is designed to address whether a patient treated for cancer who receives a single-dose of Evusheld (AZD7442) 600 mg IM or IV will maintain a stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death up to 12 months post-baseline. The program will focus on patients with cancer who have been treated with chemotherapy, immunotherapy, targeted therapy, other therapy or combination therapy with or without radiation therapy within 12 months prior to enrollment, are willing/able to receive one IM or IV injection of Evusheld, are able to complete 14 Patient Experience/Clinical Outcome Assessment (COA) surveys, 6 Quality of Life (QoL) assessments and are willing to allow serum concentrations of Evusheld to be drawn 9 times, 3 SARS-CoV-2 Receptor Binding Domain-Immunoglobulin G (RBD-IgG) tests, and T-cell assay to be drawn once. In the event of a symptomatic break-thru SARS-CoV-2 positive infection by SARS-COV-2 Ribonucleic Acid (RNA) by Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the patient will have an additional Evusheld serum concentration, SARS-CoV-2 RBD-IgG antibody level and T-cell assay obtained in a temporally related manner. The program requires treatment with Evusheld 600 mg IM or IV.
Read the detailed description
The primary objective is to quantify the serum concentration of Evusheld (AZD7442) at 1, 2, 3, 4, 5, 6, 7, 9 or 12-months post-baseline in all qualified cancer patients treated with a single-dose of Evusheld 600 mg IM or IV at baseline.
The secondary objectives of the study are as follows:
- Compare the incidence of symptomatic Sudden Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between solid tumor and hematologic malignancy patients.
- Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
- Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between solid tumor and hematologic malignancy patients.
- Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only.
- Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia and World Health Organization (WHO) score of ≥5) based on the TACKLE study definition between solid tumor and hematologic malignancy patients.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
- Compare time to first event e.g., SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) positivity, symptomatic SARS-CoV-2 infection, hospitalization, and/or death between all four strata
- Compare Quality-of-Life metrics in all cancer patients, as measured by change from baseline to days 2, 90, 180, 270, and 360 post-baseline, and then compare the same Quality-of-Life metrics at each timepoint between each of the four strata
- Assess patient safety and adverse events including medically attended visits, Emergency Room/Urgent Care/Telehealth visits using Patient Experience/Clinical Outcome Assessment (COA) survey data for patients in each of the four strata
- Evaluate whether solid tumor or hematologic malignancy patients have a greater incidence of Evusheld-related side effects
- Assess the use of Machine Learning to predict the incidence of SARS-CoV-2 infection at days 30, 60, 90, 120, 150, 180, 210, 270 and 360 post-baseline in all cancer patients based on serum Evusheld concentration levels 3.3.3 Exploratory Objectives:
- Virologic surveillance to detect all SARS-CoV-2 variants occurring during the study in patients that test positive for SARS-CoV-2 by SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing
- Detection of potential new variants identified by positive SARS-COV-2 RNA by RT-PCR testing
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Evusheld (tixagevimab+cilgavimab) IM or IV
- Keywords
- solid tumor, hematologic malignancy
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evusheld (tixagevimab+cilgavimab) IM or IVDrug
Also called AZD7442
Evusheld (tixagevimab 300 mg +cilgavimab 300 mg) IM or IV
| Study group | Role | What they receive |
|---|---|---|
| Evusheld (AZD7442) | Other | Evusheld (tixagevimab+cilgavimab) 600 mg IM or IV administered one time only Receives: Drug: Evusheld (tixagevimab+cilgavimab) IM or IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZD7442 Serum Concentration
The study's primary endpoint will assess AZD7442 serum concentration collected on days 30, 60, 90, 120 150, 180, 210, 270, and 360 post-baseline in all patients.
Measured: 12 months
Secondary outcomes (2)
Cancer Group and Treatment Group Comparison
- Serum AZD7442 concentrations at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline compared between solid tumor and hematologic malignancy patients.
- Serum AZD7442 concentrations at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline compared between patients treated with chemotherapy only, immune-therapy only, targeted therapy only or other/combination therapy only.
Measured: 12 months
SARS-CoV-2 Infection
- Incidence of symptomatic SARS-CoV-2 infections including but not limited to those with SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death compared between solid tumor and hematologic malignancy patients.
- Incidence of symptomatic SARS-CoV-2 infection including but not limited to SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death compared between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Jun 2022
- Primary completion29 Apr 2023
- Study completion30 Jun 2023
Why it stopped: FDA withdrew EUA for AZD7442
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multi-center, prospective, open-label, pragmatic evaluation
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediMergent, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Boccia, MD, Principal investigator, Center for Cancer and Blood Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438498
- Sponsor's protocol ID
- ESR 22-21698
- Status last verified
- Sep 2023
- First submitted
- 17 Jun 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2 Infection in Immuno-Suppressed Cancer Patients
- ClinicalTrials.gov ID
- NCT05438498
- Acronym / sponsor ID
- ESR 22-21698
- Conditions
- SARS-CoV-2 Infection
- Keywords
- solid tumor, hematologic malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA withdrew EUA for AZD7442
- Enrolment
- 550 participants (actual)
- Lead sponsor
- MediMergent, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Jun 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.
If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk for infection and its sequelae are significantly increased. The Astra-Zeneca Immuno-Suppressed Program (AISP) is designed to address whether a patient treated for cancer who receives a single-dose of Evusheld (AZD7442) 600 mg IM or IV will maintain a stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death up to 12 months post-baseline. The program will focus on patients with cancer who have been treated with chemotherapy, immunotherapy, targeted therapy, other therapy or combination therapy with or without radiation therapy within 12 months prior to enrollment, are willing/able to receive one IM or IV injection of Evusheld, are able to complete 14 Patient Experience/Clinical Outcome Assessment (COA) surveys, 6 Quality of Life (QoL) assessments and are willing to allow serum concentrations of Evusheld to be drawn 9 times, 3 SARS-CoV-2 Receptor Binding Domain-Immunoglobulin G (RBD-IgG) tests, and T-cell assay to be drawn once. In the event of a symptomatic break-thru SARS-CoV-2 positive infection by SARS-COV-2 Ribonucleic Acid (RNA) by Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the patient will have an additional Evusheld serum concentration, SARS-CoV-2 RBD-IgG antibody level and T-cell assay obtained in a temporally related manner. The program requires treatment with Evusheld 600 mg IM or IV.
Detailed description
The primary objective is to quantify the serum concentration of Evusheld (AZD7442) at 1, 2, 3, 4, 5, 6, 7, 9 or 12-months post-baseline in all qualified cancer patients treated with a single-dose of Evusheld 600 mg IM or IV at baseline.
The secondary objectives of the study are as follows:
- Compare the incidence of symptomatic Sudden Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between solid tumor and hematologic malignancy patients.
- Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
- Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between solid tumor and hematologic malignancy patients.
- Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only.
- Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia and World Health Organization (WHO) score of ≥5) based on the TACKLE study definition between solid tumor and hematologic malignancy patients.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
- Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
- Compare time to first event e.g., SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) positivity, symptomatic SARS-CoV-2 infection, hospitalization, and/or death between all four strata
- Compare Quality-of-Life metrics in all cancer patients, as measured by change from baseline to days 2, 90, 180, 270, and 360 post-baseline, and then compare the same Quality-of-Life metrics at each timepoint between each of the four strata
- Assess patient safety and adverse events including medically attended visits, Emergency Room/Urgent Care/Telehealth visits using Patient Experience/Clinical Outcome Assessment (COA) survey data for patients in each of the four strata
- Evaluate whether solid tumor or hematologic malignancy patients have a greater incidence of Evusheld-related side effects
- Assess the use of Machine Learning to predict the incidence of SARS-CoV-2 infection at days 30, 60, 90, 120, 150, 180, 210, 270 and 360 post-baseline in all cancer patients based on serum Evusheld concentration levels 3.3.3 Exploratory Objectives:
- Virologic surveillance to detect all SARS-CoV-2 variants occurring during the study in patients that test positive for SARS-CoV-2 by SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing
- Detection of potential new variants identified by positive SARS-COV-2 RNA by RT-PCR testing
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multi-center, prospective, open-label, pragmatic evaluation
| Arm | Type | Receives |
|---|---|---|
| Evusheld (AZD7442) | Other | Drug: Evusheld (tixagevimab+cilgavimab) IM or IVEvusheld (tixagevimab+cilgavimab) 600 mg IM or IV administered one time only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or Female gender at birth
- Age at least 18 years
- Women who are not pregnant, not breast feeding and of child bearing potential using contraception prior to enrollment in the study. Women of child bearing potential must agree to continued use of contraception throughout the 12 months of study participation.
- It is preferable that a patient has access to a "smartphone" or tablet or laptop or desktop computer and/or an email address
- In the event that a patient does not have access to any of the above, the patient may complete all follow-up surveys via the study's Call Center or in written form in the offices of the Principal Investigator as specified in the protocol
Key exclusion criteria (31 listed)
- Women who are pregnant, breast feeding or of child bearing potential and not using contraception
- Absence of a qualifying type of cancer as defined by standard ICD-10 diagnostic criteria
- Treatment initiated >12 months prior to baseline or were not on active therapy ≤12 months prior to enrollment with FDA approved oral, intramuscular and/or intravenous chemotherapy, immunotherapy, targeted therapy, other therapy or any combination of these agents
- Patient receiving only radiation therapy
- Patient with an ECOG performance status of 2 or higher
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 |
|---|---|---|
| Evusheld (tixagevimab+cilgavimab) IM or IVAlso: AZD7442Evusheld (tixagevimab 300 mg +cilgavimab 300 mg) IM or IV | Drug | Evusheld (AZD7442) |
Primary outcome
AZD7442 Serum Concentration
Time frame: 12 months
The study's primary endpoint will assess AZD7442 serum concentration collected on days 30, 60, 90, 120 150, 180, 210, 270, and 360 post-baseline in all patients.
2 secondary outcomes
Cancer Group and Treatment Group Comparison
Time frame: 12 months
SARS-CoV-2 Infection
Time frame: 12 months
Results and safety
The study was stopped early (reason given: FDA withdrew EUA for AZD7442). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
Ralph Boccia, MD principal investigator
Center for Cancer and Blood Disorders
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evusheld (tixagevimab+cilgavimab) IM or IV in people with SARS-CoV-2 Infection, run by MediMergent, LLC at 40 sites 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 25 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: FDA withdrew EUA for AZD7442). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AZD7442 Serum Concentration (time frame: 12 months). 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 8 Sep 2023.