Coronavirus Disease 2019 (COVID-19)Phase 2NCT05184062
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
A Phase 2 study testing 600 mg AZD7442 IV in people with Coronavirus Disease 2019 (COVID-19), run by AstraZeneca at 14 sites in China.
Trial summary
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- 600 mg AZD7442 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 14 sitesChina
- Study dates
- 3 Dec 2021to 6 May 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
- Healthy or medically stable participants
- Contraceptive within 365 days post dosing
Who cannot join
- Medical condition:
- Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
- Acute illness including fever on the day prior to or day of dosing.
- Any other significant disease increase the risk to participant study.
- Laboratory related:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome).
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- Serum creatinine > 176 μmol/L.
- Haemoglobin < 10g/dL.
- Platelet count < 100 × 10^3/μL.
- White blood cell count < 3.5 × 10^3/μL or neutrophil count < 1.5 × 10^3/μL.
- Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
- COVID-19 infection history/any receipt of mAb indicated for COVID-19.
- Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Research Site
Baoding, 071000
Research Site
Beijing, 100034
Research Site
Changsha, 410008
Research Site
Chongqing, 400016
Research Site
Fuzhou, 350005
Research Site
Haikou, 570311
Research Site
Hangzhou, 310006
Research Site
Lanzhou, 730030
Research Site
Shanghai, 200040
Research Site
Shanghai, 200080
Research Site
Shanghai, 200120
Research Site
Suzhou, 215004
Research Site
Ürümqi, 830054
Research Site
Xuzhou, 221000
About this study
Official title: A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).
Read the detailed description
A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- 600 mg AZD7442 IV, 600mg placebo IV
- Keywords
- Coronavirus, COVID-19, AZD7442
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg AZD7442 IVDrug
Also called AZD7442
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
600mg placebo IVDrug
Also called Placebo
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| AZD7442 | Experimental | co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. Receives: Drug: 600 mg AZD7442 IV |
| Placebo | Placebo comparator | co-administration of a single dose of 600mg placebo by intravenous (IV) infusion. Receives: Drug: 600mg placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Special Interest
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
Measured: recorded from the time of signature of the ICF up to 245 days
Secondary outcomes (1)
Serum Concentrations of AZD7442 Over Time
Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics
Measured: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start3 Dec 2021
- Primary completion15 Aug 2022
- Study completion6 May 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184062
- Sponsor's protocol ID
- D8850C00008
- Status last verified
- Sep 2024
- First submitted
- 17 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 IPD, but this does not mean all requests will be shared.
Publications
Zhang J, Zhang H, Zhang Y, Liu S, Ge X, Zhang H, Li Y, Chen CC, Stepanov O, Tang W, Zhang W. Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect. Clin Pharmacol Drug Dev. 2025 Nov;14(11):846-855. doi: 10.1002/cpdd.1586. Epub 2025 Sep 5.
PubMed 40910575Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
- ClinicalTrials.gov ID
- NCT05184062
- Acronym / sponsor ID
- D8850C00008
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Coronavirus, COVID-19, AZD7442
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).
Detailed description
A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7442 | Experimental | Drug: 600 mg AZD7442 IVco-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. |
| Placebo | Placebo comparator | Drug: 600mg placebo IVco-administration of a single dose of 600mg placebo by intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
- Healthy or medically stable participants
- Contraceptive within 365 days post dosing
Key exclusion criteria (13 listed)
- Medical condition:
- Laboratory related:
- COVID-19 infection history/any receipt of mAb indicated for COVID-19.
- Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1
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 |
|---|---|---|
| 600 mg AZD7442 IVAlso: AZD7442Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion. | Drug | AZD7442 |
| 600mg placebo IVAlso: PlaceboParticipants will be randomized to receive co-administration of 600mg placebo by a single IV infusion. | Drug | Placebo |
Primary outcome
Adverse Events of Special Interest
Time frame: recorded from the time of signature of the ICF up to 245 days
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
1 secondary outcome
Serum Concentrations of AZD7442 Over Time
Time frame: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40910575Zhang J, Zhang H, Zhang Y, Liu S, Ge X, Zhang H, Li Y, Chen CC, Stepanov O, Tang W, Zhang W. Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect. Clin Pharmacol Drug Dev. 2025 Nov;14(11):846-855. doi: 10.1002/cpdd.1586. Epub 2025 Sep 5.
- Derived from this study: PubMed 35713300Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
- CSR\_synopsisLink provided by the sponsor.
- protocol\_redactedLink provided by the sponsor.
- SAP\_redactedLink 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 600 mg AZD7442 IV in people with Coronavirus Disease 2019 (COVID-19), run by AstraZeneca at 14 sites 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 4 inclusion and 13 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Nov 2024). 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?
Adverse Events of Special Interest (time frame: recorded from the time of signature of the ICF up to 245 days). 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 NCT05184062, which also lists 2 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 21 Nov 2024.