A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
TerminatedPhase 2Results postedLast updated 23 October 2024
What this trial tests
Phase 2 trial testing AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061]) in Coronavirus Disease 2019 (COVID-19) in 251 participants. Terminated before completion.
12 and older, any sex, with Coronavirus Disease 2019 (COVID-19). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
AEs, SAEs, and AESIsPrimary· Safety data were recorded from the time of the first IMP administration throughout the study for an average safety follow up time of 48.85 weeks. This was shorter than the planned one of 105 weeks due to FDA's request to halt dosing.
To evaluate the safety and tolerability of AZD7442
Adverse Events
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
84
AZD7442: 1200 mg ONCE / 600mg Q6M
66
Serious Adverse Events
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
13
AZD7442: 1200 mg ONCE / 600mg Q6M
10
Adverse Events of Special Interest
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
9
AZD7442: 1200 mg ONCE / 600mg Q6M
7
ADA in Serum ResponsesPrimary· Serum ADA were assessed through the treatment period at the specific timepoints: baseline, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365, 456 days or early discontinuation visit after the first IMP administration.
To evaluate the immunogenicity of AZD7442
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1
AZD7442: 1200 mg ONCE / 600mg Q6M
3
Serum AZD7442 ConcentrationsSecondary· Serum PK was assessed through the treatment period at the specific timepoints: day 1 post-dose (600mg Q6M arm only), 3, 11, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365 days or early discontinuation visit after the first IMP administration.
To evaluate the PK of AZD7442 in serum
Day 1, Post-dose
Group
Value
95% CI
AZD7442: 1200 mg ONCE / 600mg Q6M
285.8539
± 176.0959
Day 3
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
30.0089
± 83.7707
AZD7442: 1200 mg ONCE / 600mg Q6M
165.1457
± 196.9756
Day 11
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
45.5626
± 53.9503
AZD7442: 1200 mg ONCE / 600mg Q6M
123.2505
± 160.5606
Day 29
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
40.0381
± 48.7457
AZD7442: 1200 mg ONCE / 600mg Q6M
105.8292
± 76.5535
Day 92
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
27.9754
± 48.9241
AZD7442: 1200 mg ONCE / 600mg Q6M
63.0711
± 76.0487
Day 121
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
42.1820
± 53.2624
Day 183
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
23.8985
± 58.4175
AZD7442: 1200 mg ONCE / 600mg Q6M
26.4300
± 85.1380
Day 212
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
36.5360
± 54.5622
AZD7442: 1200 mg ONCE / 600mg Q6M
60.5211
± 44.6566
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay)Secondary· SARSCoV-2 nAbs (Wild Type Assay) were assessed through the treatment period at these specific timepoints: baseline, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365 days or early termination visit after the first IMP administration.
To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442
Baseline Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
203.5
± 6.43
AZD7442: 1200 mg ONCE / 600mg Q6M
198.9
± 7.70
Day 29 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1442.8
± 1.88
AZD7442: 1200 mg ONCE / 600mg Q6M
3497.1
± 2.10
Day 92 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1052.5
± 2.22
AZD7442: 1200 mg ONCE / 600mg Q6M
2268.6
± 2.30
Day 121 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1520.2
± 1.97
Day 183 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1209.8
± 1.95
AZD7442: 1200 mg ONCE / 600mg Q6M
1337.9
± 2.10
Day 212 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
941.2
± 2.08
AZD7442: 1200 mg ONCE / 600mg Q6M
1436.1
± 1.78
Day 274 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
488.5
± 2.38
AZD7442: 1200 mg ONCE / 600mg Q6M
864.7
± 1.98
Day 365 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
482.1
± 1.21
AZD7442: 1200 mg ONCE / 600mg Q6M
578.9
± 2.21
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay)Secondary· SARSCoV-2 nAbs (Pseudo Neutralization Assay) were assessed through the study at these specific timepoints: baseline, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365 days or early termination visit after the first IMP administration.
To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442
Baseline Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1613.3
± 7.96
AZD7442: 1200 mg ONCE / 600mg Q6M
1735.8
± 8.35
Day 29 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
32170.5
± 1.86
AZD7442: 1200 mg ONCE / 600mg Q6M
111726.8
± 1.75
Day 92 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
13940.9
± 1.88
AZD7442: 1200 mg ONCE / 600mg Q6M
38048.0
± 1.73
Day 121 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
23177.5
± 1.87
Day 183 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
12018.5
± 1.75
AZD7442: 1200 mg ONCE / 600mg Q6M
15554.6
± 1.80
Day 212 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
19353.3
± 1.72
AZD7442: 1200 mg ONCE / 600mg Q6M
36519.3
± 1.67
Day 274 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
12816.8
± 1.93
AZD7442: 1200 mg ONCE / 600mg Q6M
23583.5
± 1.91
Day 365 Titer
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
5068.4
± 1.55
AZD7442: 1200 mg ONCE / 600mg Q6M
7155.4
± 2.01
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay)Secondary· SARSCoV-2 nAbs (Wild Type Assay) were assessed through the treatment period at these specific timepoints: baseline, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365 days or early termination visit after the first IMP administration.
To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442
Day 29 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
6.87
± 4.765
AZD7442: 1200 mg ONCE / 600mg Q6M
16.79
± 6.429
Day 92 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
4.32
± 4.329
AZD7442: 1200 mg ONCE / 600mg Q6M
10.53
± 6.362
Day 121 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
6.53
± 4.928
Day 183 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
5.29
± 4.744
AZD7442: 1200 mg ONCE / 600mg Q6M
5.43
± 5.122
Day 212 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
4.09
± 5.554
AZD7442: 1200 mg ONCE / 600mg Q6M
5.28
± 6.243
Day 274 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
1.96
± 4.385
AZD7442: 1200 mg ONCE / 600mg Q6M
3.08
± 5.820
Day 365 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
9.97
± 1.093
AZD7442: 1200 mg ONCE / 600mg Q6M
2.00
± 5.343
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay)Secondary· SARSCoV-2 nAbs (Pseudo Neutralization Assay) were assessed through the study at these specific timepoints: baseline, 29, 92, 121 (300mg Q3M arm only), 183, 212, 274, 365 days or early termination visit after the first IMP administration.
To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442
Day 29 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
18.02
± 7.081
AZD7442: 1200 mg ONCE / 600mg Q6M
58.84
± 8.473
Day 92 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
7.82
± 7.270
AZD7442: 1200 mg ONCE / 600mg Q6M
20.38
± 8.068
Day 121 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
13.13
± 8.439
Day 183 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
7.28
± 6.954
AZD7442: 1200 mg ONCE / 600mg Q6M
6.90
± 7.185
Day 212 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
10.28
± 6.969
AZD7442: 1200 mg ONCE / 600mg Q6M
14.44
± 7.457
Day 274 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
7.06
± 6.133
AZD7442: 1200 mg ONCE / 600mg Q6M
8.99
± 8.271
Day 365 fold rise
Group
Value
95% CI
AZD7442: 600mg ONCE / 300mg Q3M
12.64
± 1.251
AZD7442: 1200 mg ONCE / 600mg Q6M
2.84
± 8.353
Adverse events — posted to ClinicalTrials.gov
Time frame: Safety data were recorded from the time of the first IMP administration throughout the study for an average safety follow up time of 48.85 weeks. This was shorter than the planned one of 105 weeks due to FDA's request to halt dosing..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AZD7442: 600mg ONCE / 300mg Q3M
Serious: 13/124 (10%)
Deaths: 0/124
AZD7442: 1200 mg ONCE / 600mg Q6M
Serious: 10/124 (8%)
Deaths: 1/124
Serious adverse events (34 terms)
Reaction
System
AZD7442: 600mg ONCE / 300m…
AZD7442: 1200 mg ONCE / 60…
Pneumonia
Infections and infestations
—
—
Pneumonia bacterial
Infections and infestations
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Abscess limb
Infections and infestations
—
—
Covid-19
Infections and infestations
—
—
Diverticulitis
Infections and infestations
—
—
Escherichia pyelonephritis
Infections and infestations
—
—
Escherichia sepsis
Infections and infestations
—
—
Escherichia urinary tract infection
Infections and infestations
—
—
Gastroenteritis norovirus
Infections and infestations
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Pulmonary sepsis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Urinary tract infection bacterial
Infections and infestations
—
—
Angina pectoris
Cardiac disorders
—
—
Gastrointestinal anastomotic stenosis
Injury, poisoning and procedural complications
—
—
Subdural haematoma
Injury, poisoning and procedural complications
—
—
Angina unstable
Cardiac disorders
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 23 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05375760.