SARS-CoV-2Phase 1TRUSTNCT05281601
AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics
A Phase 1 study testing AZD7442 in people with SARS-CoV-2, run by AstraZeneca at 11 sites in 5 countries.
Trial summary
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- AZD7442
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 21 Mar 2022to 16 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant must be aged ≥ 29 weeks gestational age (GA) to < 18 years of age.
- Participant must weigh a minimum of 1.5 kg.
- COHORT 1
- Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
- Increased risk for SARS-CoV-2 infection.
- Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
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- A negative RT-PCR test collected ≤ 3 days prior to Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
- No COVID-19 symptoms prior to enrollment within 10 days of dosing.
- Increased risk for SARS-CoV-2 infection.
- COHORT 2
- Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
- Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
- A positive RT-PCR test collected ≤ 3 days prior to Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
- Symptomatic participants must be dosed with IMP no more than 7 days from the self-reported date of first reported sign/symptom.
- Oxygenation saturation of ≥ 92% obtained at rest within 24 hours prior to Day 1 unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
- Note that Cohort 2 will only be included if the indication is progressed in adults.
- COHORT 3
- Participants hospitalized with COVID-19 with a time between onset of symptoms and dosing AZD7442 of ≤ 7 days.
- A positive RT-PCR test collected ≤ 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
- Spontaneous blood Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) levels ≤ 5 times the ULN.
- Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2.
- Participants will receive IM AZD7442 unless they meet any of the following criteria for IV administration:
- The participant has severe COVID-19.
- Contraindication of intramuscular (IM) dose due to thrombocytopenia, coagulation defects or any other condition that would compromise the absorption of AZD7442 or safety of the participant.
- Physician considers IV the appropriate route.
Who cannot join
- All Cohorts
- Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to receiving AZD7442.
- History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
- Cohorts 1 and 2: Current need for immediate medical attention or current need for hospitalization.
- Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
- History of allergic or reaction to any component of the study drug formulation.
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- History of hypersensitivity, injection/infusion-relation reactions or severe adverse reactions following administration of a monoclonal antibody (mAb).
- Co-morbidity requiring surgery within 7 days prior to study entry or is deemed life-threatening within 30 days prior to study entry.
- Prior receipt of convalescent COVID-19 plasma/sera or hyperimmune globulin therapy.
- Prior receipt of mAb/biologic indicated for the prevention of SARS-CoV-2, treatment of COVID-19, or expected receipt during the period of study follow-up.
- Prior receipt of a COVID-19 vaccine ≤ 14 days before screening or plan to receive a COVID-19 vaccination ≤ 14 days after IMP administration at study Visit 1.
- History of alcohol or drug abuse within the past 2 years.
- Investigational Drugs or Devices: Treatment with investigational drug or device in another clinical trial within the last 30 days or 5 half-lives of the drug (whichever is longer) prior to screening. Note: Participation in observational studies (ie, studies that do not require medication, blood draws, or an additional intervention) is not exclusionary. Interventional trials which do not include investigational drugs (only include approved therapies), or investigational treatment regimens may be considered if the blood draw requirements and study interventions are minimal and not deemed by the Investigator to interfere with completion of the planned study sampling and follow-up.
- Vulnerable persons (eg, ward of the state, kept in detention).
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States7 sites
Research Site
Aurora, Colorado, 80045
Research Site
Idaho Falls, Idaho, 83404
Research Site
Long Beach, California, 90806
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Providence, Rhode Island, 02903
Research Site
Stony Brook, New York, 11794
Research Site
Washington D.C., District of Columbia, 20007
About this study
Official title: Open-Label, Uncontrolled, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged ≥ 29 Weeks Gestational Age to < 18 Years
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
Read the detailed description
This is a Phase I, open-label, uncontrolled, multi-country, multi-center, single-dose study. Initially, 2 cohorts of participants will be enrolled: 1) participants who are severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) negative at screening and have not knowingly been exposed to a SARS-CoV-2 positive individual (pre-exposure prophylaxis); and 2) participants who are SARS-CoV-2 RT-PCR positive at screening and have mild to moderate COVID-19 symptoms. A third cohort might be added for the treatment of severe COVID-19. If included, this third cohort will include participants who are SARS-CoV-2 positive at screening and have severe COVID-19.
- Conditions
- SARS-CoV-2
- Being tested
- AZD7442
- Keywords
- AZD7442, Monoclonal antibodies (mAb), COVID-19, EVUSHELD
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7442Drug
Also called Evusheld
IM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order.
IV Administration: AZD7442 is dosed by co-administration of AZD8895 and AZD1061 in a single IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| AZD7442 | Experimental | All participants will receive a single dose of AZD7442 on Day 1, either IM (AZD8895 followed by AZD1061) or IV (AZD8895 + AZD1061 concurrently). Receives: Drug: AZD7442 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Concentrations of AZD7442
The serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants were evaluated. The serum concentrations for each scheduled time point were summarized by route of administration using appropriate descriptive statistics, based on the (Pharmacokinetic analysis) PK analysis set.
Measured: IM - Day 4, Day 8, Day 11, Day 15 and Day 366; IV - Day 1, Day 4, Day 8, Day 11, Day 15 and Day 366
Maximum Serum Concentration (Cmax)
The Cmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approximately [approx.] 24 months)
Time to Reach Maximum Serum Concentration (Tmax)
The tmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Terminal Half-life (t1/2)
The t1/2 of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)
The AUC0-last of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
The AUC0-inf of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Time to Last Measurable Concentration (Tlast)
The tlast of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Percentage of AUC0-inf Extrapolated to Infinity (% AUCex)
The %AUCex of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Apparent Total Clearance (CL/F)
The CL/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
The Vz/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Systemic Clearance (CL)
The CL of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Volume of Distribution at Steady State (Vss)
The Vss of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Number of Participants With Adverse Events (AE)
The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Number of Participants With Adverse Event of Special Interest (AESI)
Number of pediatric participants with AESI after a single IM or IV dose were evaluated.
An AESI is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product.
Measured: Day 1 to day 366 or early discontinuation visit (approx. 24 months)
Secondary outcomes (5)
Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442.
The immunogenicity profile of AZD7442 after a single IM or IV dose in pediatric participants was evaluated.
A participant is defined as ADA-positive to AZD7442 if they have a positive ADA result to AZD8895 and/or AZD1061 at any time, including baseline and all postbaseline.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 2 - Percentage of Participants With Progression of COVID-19 Through Day 29
Percentage of participants with progression of COVID-19 through Day 29 in Cohort 2 in pediatric participants was evaluated.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 2 - Number of Participants With COVID-19 Related Death Occurring After Dosing With IMP Through 90 Days
Number of participants with COVID-19 related death occurring after dosing with IMP through 90 days in Cohort 2 in pediatric participants were evaluated.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Titre of SARS-CoV-2 Neutralizing Antibodies
The pharmacodynamics of AZD7442 after a single dose in pediatric participants was evaluated.
The result for overall vaccination status were presented.
Measured: Day 31 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections
Number of participants with SARS-CoV-2 infections with or without COVID-19 symptoms after a single IM or IV dose of AZD7442 in pediatric participants were evaluated.
Measured: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start21 Mar 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281601
- Sponsor's protocol ID
- D8850C00006
- Other IDs
- 2021-006056-13
- Acronym
- TRUST
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2022
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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 IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Uncontrolled, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged ≥ 29 Weeks Gestational Age to < 18 Years
- ClinicalTrials.gov ID
- NCT05281601
- Acronym / sponsor ID
- TRUST / D8850C00006
- Conditions
- SARS-CoV-2
- Keywords
- AZD7442, Monoclonal antibodies (mAb), COVID-19, EVUSHELD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Posted 18 Apr 2025
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 evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
Detailed description
This is a Phase I, open-label, uncontrolled, multi-country, multi-center, single-dose study. Initially, 2 cohorts of participants will be enrolled: 1) participants who are severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) negative at screening and have not knowingly been exposed to a SARS-CoV-2 positive individual (pre-exposure prophylaxis); and 2) participants who are SARS-CoV-2 RT-PCR positive at screening and have mild to moderate COVID-19 symptoms. A third cohort might be added for the treatment of severe COVID-19. If included, this third cohort will include participants who are SARS-CoV-2 positive at screening and have severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD7442 | Experimental | Drug: AZD7442All participants will receive a single dose of AZD7442 on Day 1, either IM (AZD8895 followed by AZD1061) or IV (AZD8895 + AZD1061 concurrently). |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (25 listed)
- Participant must be aged ≥ 29 weeks gestational age (GA) to < 18 years of age.
- Participant must weigh a minimum of 1.5 kg.
- COHORT 1
- Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
- Increased risk for SARS-CoV-2 infection.
Key exclusion criteria (14 listed)
- All Cohorts
- Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to receiving AZD7442.
- History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
- Cohorts 1 and 2: Current need for immediate medical attention or current need for hospitalization.
- Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
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 |
|---|---|---|
| AZD7442Also: EvusheldIM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order. IV Administration: AZD7442 is dosed by co-administration of AZD8895 and AZD1061 in a single IV infusion. | Drug | AZD7442 |
Primary outcome
Serum Concentrations of AZD7442
Time frame: IM - Day 4, Day 8, Day 11, Day 15 and Day 366; IV - Day 1, Day 4, Day 8, Day 11, Day 15 and Day 366
The serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants were evaluated. The serum concentrations for each scheduled time point were summarized by route of administration using appropriate descriptive statistics, based on the (Pharmacokinetic analysis) PK analysis set.
Maximum Serum Concentration (Cmax)
Time frame: Day 1 to Day 366 or early discontinuation visit (approximately [approx.] 24 months)
The Cmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Time to Reach Maximum Serum Concentration (Tmax)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The tmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Terminal Half-life (t1/2)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The t1/2 of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The AUC0-last of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The AUC0-inf of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Time to Last Measurable Concentration (Tlast)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The tlast of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Percentage of AUC0-inf Extrapolated to Infinity (% AUCex)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The %AUCex of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Apparent Total Clearance (CL/F)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The CL/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The Vz/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Systemic Clearance (CL)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The CL of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Volume of Distribution at Steady State (Vss)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The Vss of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Number of Participants With Adverse Events (AE)
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated.
Number of Participants With Adverse Event of Special Interest (AESI)
Time frame: Day 1 to day 366 or early discontinuation visit (approx. 24 months)
Number of pediatric participants with AESI after a single IM or IV dose were evaluated. An AESI is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product.
5 secondary outcomes
Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442.
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 2 - Percentage of Participants With Progression of COVID-19 Through Day 29
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 2 - Number of Participants With COVID-19 Related Death Occurring After Dosing With IMP Through 90 Days
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Titre of SARS-CoV-2 Neutralizing Antibodies
Time frame: Day 31 to Day 366 or early discontinuation visit (approx. 24 months)
Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections
Time frame: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D8850C00006\_Redacted\_CSPLink provided by the sponsor.
- D8850C00006\_Redacted\_CSR\_SynopsiLink provided by the sponsor.
- D8850C00006\_Redacted\_SAP.Link 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 IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7442 in people with SARS-CoV-2, run by AstraZeneca at 11 sites in 5 countries.
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 14 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Brazil, Germany, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Concentrations of AZD7442 (time frame: IM - Day 4, Day 8, Day 11, Day 15 and Day 366; IV - Day 1, Day 4, Day 8, Day 11, Day 15 and Day 366). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.