Trial Outcomes & Findings for 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 (NCT NCT05375760)

NCT ID: NCT05375760

Last Updated: 2024-10-23

Results Overview

To evaluate the safety and tolerability of AZD7442

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

251 participants

Primary outcome timeframe

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.

Results posted on

2024-10-23

Participant Flow

The participants were screened and randomized from the USA. First subject in was on 09Jun2022 and the last subject last visit was 04Oct2023. Sponsor terminated the study after review of FDA's request to halt further dosing (30Mar2023) and subjects were terminated prior to 1 year dose given that AZD7442 is not active against \>99% of the currently circulating SARS-CoV-2 variants in the USA, the benefit risk assessment may not be favorable.

Participant milestones

Participant milestones
Measure	AZD7442: 600 mg ONCE / 300mg Q3M AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200mg ONCE / 600mg Q6M AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Overall Study STARTED	125	126
Overall Study Treated	124	124
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	125	126

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD7442: 600 mg ONCE / 300mg Q3M AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200mg ONCE / 600mg Q6M AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Overall Study Adverse Event	1	0
Overall Study Death	0	1
Overall Study Lost to Follow-up	6	6
Overall Study Withdrawal by Subject	17	19
Overall Study Dosing halted by FDA	96	100
Overall Study Not compliant with study visit	2	0
Overall Study Physician Decision	1	0
Overall Study Signed ICF addendum, however refused procedures	1	0
Overall Study Participant moved	1	0

Baseline Characteristics

Safety Analysis Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=124 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=124 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.	Total n=248 Participants Total of all reporting groups
Age, Continuous	57.3 Years STANDARD_DEVIATION 13.97 • n=124 Participants	54.2 Years STANDARD_DEVIATION 14.85 • n=124 Participants	55.7 Years STANDARD_DEVIATION 14.47 • n=248 Participants
Age, Customized >=12 - <18	0 Participants n=124 Participants	0 Participants n=124 Participants	0 Participants n=248 Participants
Age, Customized >=18 - <65	86 Participants n=124 Participants	98 Participants n=124 Participants	184 Participants n=248 Participants
Age, Customized >=65 - <75	26 Participants n=124 Participants	12 Participants n=124 Participants	38 Participants n=248 Participants
Age, Customized >=75 - <80	9 Participants n=124 Participants	7 Participants n=124 Participants	16 Participants n=248 Participants
Age, Customized >=80	3 Participants n=124 Participants	7 Participants n=124 Participants	10 Participants n=248 Participants
Sex: Female, Male Female	65 Participants n=124 Participants • Safety Analysis Set	67 Participants n=124 Participants • Safety Analysis Set	132 Participants n=248 Participants • Safety Analysis Set
Sex: Female, Male Male	59 Participants n=124 Participants • Safety Analysis Set	57 Participants n=124 Participants • Safety Analysis Set	116 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Hispanic or Latino	63 Participants n=124 Participants • Safety Analysis Set	60 Participants n=124 Participants • Safety Analysis Set	123 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Not Hispanic or Latino	60 Participants n=124 Participants • Safety Analysis Set	64 Participants n=124 Participants • Safety Analysis Set	124 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Not reported	1 Participants n=124 Participants • Safety Analysis Set	3 Participants n=124 Participants • Safety Analysis Set	4 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Unknown	1 Participants n=124 Participants • Safety Analysis Set	0 Participants n=124 Participants • Safety Analysis Set	1 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized White	96 Participants n=124 Participants • Safety Analysis Set	94 Participants n=124 Participants • Safety Analysis Set	190 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Black or African American	20 Participants n=124 Participants • Safety Analysis Set	23 Participants n=124 Participants • Safety Analysis Set	43 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Asian	3 Participants n=124 Participants • Safety Analysis Set	3 Participants n=124 Participants • Safety Analysis Set	6 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=124 Participants • Safety Analysis Set	1 Participants n=124 Participants • Safety Analysis Set	2 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=124 Participants • Safety Analysis Set	0 Participants n=124 Participants • Safety Analysis Set	0 Participants n=248 Participants • Safety Analysis Set
Race/Ethnicity, Customized Multiple	2 Participants n=124 Participants • Safety Analysis Set	0 Participants n=124 Participants • Safety Analysis Set	2 Participants n=248 Participants • Safety Analysis Set
Screening result from Nasopharyngeal swab for SARS-CoV-2 RT-PCR Negative	124 Participants n=124 Participants	124 Participants n=124 Participants	248 Participants n=248 Participants
Screening result from Nasopharyngeal swab for SARS-CoV-2 RT-PCR Positive	0 Participants n=124 Participants	0 Participants n=124 Participants	0 Participants n=248 Participants
Previous COVID-19 vaccination Yes	26 Participants n=124 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories	19 Participants n=124 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories	45 Participants n=248 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories
Previous COVID-19 vaccination No	98 Participants n=124 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories	105 Participants n=124 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories	203 Participants n=248 Participants • The numbers in the different subcategories (row) are cumulative. So they do not sum up to the made categories
Time since previous COVID-19 vaccination	107.0 Days n=26 Participants • Number of participants with a previous COVID-19 infection	205.0 Days n=19 Participants • Number of participants with a previous COVID-19 infection	138.0 Days n=45 Participants • Number of participants with a previous COVID-19 infection
Smoking history Current	23 Participants n=124 Participants	13 Participants n=124 Participants	36 Participants n=248 Participants
Smoking history Former	28 Participants n=124 Participants	24 Participants n=124 Participants	52 Participants n=248 Participants
Smoking history Never	73 Participants n=124 Participants	87 Participants n=124 Participants	160 Participants n=248 Participants
Number of pack years (Current or Former)	18.9 percentages STANDARD_DEVIATION 19.27 • n=51 Participants • Number of participants having current or former smoking history	20.0 percentages STANDARD_DEVIATION 18.74 • n=37 Participants • Number of participants having current or former smoking history	19.3 percentages STANDARD_DEVIATION 18.95 • n=88 Participants • Number of participants having current or former smoking history
Weight (kg)	81.17 kg STANDARD_DEVIATION 20.764 • n=124 Participants	83.27 kg STANDARD_DEVIATION 19.258 • n=124 Participants	82.22 kg STANDARD_DEVIATION 20.013 • n=248 Participants
Height (cm)	168.18 cm STANDARD_DEVIATION 10.406 • n=124 Participants	167.68 cm STANDARD_DEVIATION 9.946 • n=124 Participants	167.93 cm STANDARD_DEVIATION 10.162 • n=248 Participants
Body Mass Index (kg/m^2)	28.66 kg/m^2 STANDARD_DEVIATION 6.884 • n=124 Participants	29.66 kg/m^2 STANDARD_DEVIATION 6.582 • n=124 Participants	29.16 kg/m^2 STANDARD_DEVIATION 6.740 • n=248 Participants
Body Mass Index (kg/m^2) Category < 25	32 Participants n=124 Participants	26 Participants n=124 Participants	58 Participants n=248 Participants
Body Mass Index (kg/m^2) Category 25 - <30	52 Participants n=124 Participants	47 Participants n=124 Participants	99 Participants n=248 Participants
Body Mass Index (kg/m^2) Category 30 - <35	25 Participants n=124 Participants	29 Participants n=124 Participants	54 Participants n=248 Participants
Body Mass Index (kg/m^2) Category >= 35	15 Participants n=124 Participants	22 Participants n=124 Participants	37 Participants n=248 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety Analysis Set

To evaluate the safety and tolerability of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=124 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=124 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
AEs, SAEs, and AESIs Adverse Events	84 Participants	66 Participants
AEs, SAEs, and AESIs Serious Adverse Events	13 Participants	10 Participants
AEs, SAEs, and AESIs Adverse Events of Special Interest	9 Participants	7 Participants

PRIMARY outcome

Timeframe: 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.

Population: ADA Evaluable Analysis set

To evaluate the immunogenicity of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=106 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=111 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
ADA in Serum Responses	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Population: PK Analysis Set

To evaluate the PK of AZD7442 in serum

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=107 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=116 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Serum AZD7442 Concentrations Day 1, Post-dose	—	285.8539 ug/mL Geometric Coefficient of Variation 176.0959
Serum AZD7442 Concentrations Day 3	30.0089 ug/mL Geometric Coefficient of Variation 83.7707	165.1457 ug/mL Geometric Coefficient of Variation 196.9756
Serum AZD7442 Concentrations Day 11	45.5626 ug/mL Geometric Coefficient of Variation 53.9503	123.2505 ug/mL Geometric Coefficient of Variation 160.5606
Serum AZD7442 Concentrations Day 29	40.0381 ug/mL Geometric Coefficient of Variation 48.7457	105.8292 ug/mL Geometric Coefficient of Variation 76.5535
Serum AZD7442 Concentrations Day 92	27.9754 ug/mL Geometric Coefficient of Variation 48.9241	63.0711 ug/mL Geometric Coefficient of Variation 76.0487
Serum AZD7442 Concentrations Day 121	42.1820 ug/mL Geometric Coefficient of Variation 53.2624	—
Serum AZD7442 Concentrations Day 183	23.8985 ug/mL Geometric Coefficient of Variation 58.4175	26.4300 ug/mL Geometric Coefficient of Variation 85.1380
Serum AZD7442 Concentrations Day 212	36.5360 ug/mL Geometric Coefficient of Variation 54.5622	60.5211 ug/mL Geometric Coefficient of Variation 44.6566
Serum AZD7442 Concentrations Day 274	24.3601 ug/mL Geometric Coefficient of Variation 59.3582	38.1694 ug/mL Geometric Coefficient of Variation 55.8293
Serum AZD7442 Concentrations Day 365	21.2009 ug/mL Geometric Coefficient of Variation 46.2521	17.2078 ug/mL Geometric Coefficient of Variation 91.1273
Serum AZD7442 Concentrations Confirmed Illness 1 Day 1	36.2743 ug/mL Geometric Coefficient of Variation 30.3957	103.0573 ug/mL Geometric Coefficient of Variation 43.1944
Serum AZD7442 Concentrations Confirmed Illness 1 Day 14	37.2795 ug/mL Geometric Coefficient of Variation 25.1834	79.1638 ug/mL Geometric Coefficient of Variation 29.7188

SECONDARY outcome

Timeframe: 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.

Population: nAb Evaluable Analysis Set - Authentic Virus

To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=112 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=119 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 212 Titer	941.2 Titer Standard Deviation 2.08	1436.1 Titer Standard Deviation 1.78
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 274 Titer	488.5 Titer Standard Deviation 2.38	864.7 Titer Standard Deviation 1.98
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 365 Titer	482.1 Titer Standard Deviation 1.21	578.9 Titer Standard Deviation 2.21
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Baseline Titer	203.5 Titer Standard Deviation 6.43	198.9 Titer Standard Deviation 7.70
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 29 Titer	1442.8 Titer Standard Deviation 1.88	3497.1 Titer Standard Deviation 2.10
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 92 Titer	1052.5 Titer Standard Deviation 2.22	2268.6 Titer Standard Deviation 2.30
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 121 Titer	1520.2 Titer Standard Deviation 1.97	—
Changes From Baseline in GMTs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 183 Titer	1209.8 Titer Standard Deviation 1.95	1337.9 Titer Standard Deviation 2.10

SECONDARY outcome

Timeframe: 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.

Population: nAb Evaluable Analysis Set - Pseudo Virus

To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=112 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=119 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Baseline Titer	1613.3 Titer Standard Deviation 7.96	1735.8 Titer Standard Deviation 8.35
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 29 Titer	32170.5 Titer Standard Deviation 1.86	111726.8 Titer Standard Deviation 1.75
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 92 Titer	13940.9 Titer Standard Deviation 1.88	38048.0 Titer Standard Deviation 1.73
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 121 Titer	23177.5 Titer Standard Deviation 1.87	—
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 183 Titer	12018.5 Titer Standard Deviation 1.75	15554.6 Titer Standard Deviation 1.80
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 212 Titer	19353.3 Titer Standard Deviation 1.72	36519.3 Titer Standard Deviation 1.67
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 274 Titer	12816.8 Titer Standard Deviation 1.93	23583.5 Titer Standard Deviation 1.91
Changes From Baseline in GMTs in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 365 Titer	5068.4 Titer Standard Deviation 1.55	7155.4 Titer Standard Deviation 2.01

SECONDARY outcome

Population: nAb Evaluable Analysis Set - Authentic Virus

To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=112 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=119 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 29 fold rise	6.87 Fold rise Standard Deviation 4.765	16.79 Fold rise Standard Deviation 6.429
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 92 fold rise	4.32 Fold rise Standard Deviation 4.329	10.53 Fold rise Standard Deviation 6.362
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 121 fold rise	6.53 Fold rise Standard Deviation 4.928	—
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 183 fold rise	5.29 Fold rise Standard Deviation 4.744	5.43 Fold rise Standard Deviation 5.122
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 212 fold rise	4.09 Fold rise Standard Deviation 5.554	5.28 Fold rise Standard Deviation 6.243
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 274 fold rise	1.96 Fold rise Standard Deviation 4.385	3.08 Fold rise Standard Deviation 5.820
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Wild-type Assay) Day 365 fold rise	9.97 Fold rise Standard Deviation 1.093	2.00 Fold rise Standard Deviation 5.343

SECONDARY outcome

Population: nAb Evaluable Analysis Set - Pseudo Virus

To determine anti severe acute respiratory coronavirus-2 neutralizing antibodies (anti-SARS-CoV 2 nAb) levels in serum after administration of AZD7442

Outcome measures

Outcome measures
Measure	AZD7442: 600mg ONCE / 300mg Q3M n=112 Participants AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=119 Participants AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 29 fold rise	18.02 Fold rise Standard Deviation 7.081	58.84 Fold rise Standard Deviation 8.473
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 92 fold rise	7.82 Fold rise Standard Deviation 7.270	20.38 Fold rise Standard Deviation 8.068
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 121 fold rise	13.13 Fold rise Standard Deviation 8.439	—
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 183 fold rise	7.28 Fold rise Standard Deviation 6.954	6.90 Fold rise Standard Deviation 7.185
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 212 fold rise	10.28 Fold rise Standard Deviation 6.969	14.44 Fold rise Standard Deviation 7.457
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 274 fold rise	7.06 Fold rise Standard Deviation 6.133	8.99 Fold rise Standard Deviation 8.271
Changes From Baseline in GMFRs Values in SARSCoV- 2 nAbs (Pseudo Neutralization Assay) Day 365 fold rise	12.64 Fold rise Standard Deviation 1.251	2.84 Fold rise Standard Deviation 8.353

Adverse Events

AZD7442: 600mg ONCE / 300mg Q3M

Serious events: 13 serious events

Other events: 76 other events

Deaths: 0 deaths

AZD7442: 1200 mg ONCE / 600mg Q6M

Serious events: 10 serious events

Other events: 58 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AZD7442: 600mg ONCE / 300mg Q3M n=124 participants at risk AZD7442 600 mg intramuscularly (IM) on Day 1 followed by 300 mg IM every 3 months (Q3M) for 12 months.	AZD7442: 1200 mg ONCE / 600mg Q6M n=124 participants at risk AZD7442 1200 mg intravenously (IV) on Day 1 followed by 600 mg IM every 6 months (Q6M) for 12 months.
Blood and lymphatic system disorders Anaemia	0.81% 1/124 • Number of events 1 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Abscess limb	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Covid-19	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Diverticulitis	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Escherichia pyelonephritis	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Escherichia sepsis	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Escherichia urinary tract infection	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Gastroenteritis norovirus	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Cardiac disorders Acute myocardial infarction	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Pneumonia	1.6% 2/124 • Number of events 2 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Pneumonia bacterial	0.00% 0/124 • 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.	1.6% 2/124 • Number of events 2 • 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.
Infections and infestations Pulmonary sepsis	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Infections and infestations Sepsis	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Urinary tract infection	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Infections and infestations Urinary tract infection bacterial	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 2 • 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.
Cardiac disorders Angina pectoris	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Injury, poisoning and procedural complications Gastrointestinal anastomotic stenosis	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Injury, poisoning and procedural complications Subdural haematoma	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Cardiac disorders Angina unstable	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Nervous system disorders Focal dyscognitive seizures	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Nervous system disorders Syncope	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Nervous system disorders Uraemic encephalopathy	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Renal and urinary disorders Acute kidney injury	0.81% 1/124 • Number of events 1 • 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.	0.81% 1/124 • Number of events 1 • 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.
Renal and urinary disorders Hydronephrosis	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/124 • 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.	1.6% 2/124 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.81% 1/124 • Number of events 2 • 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.	0.00% 0/124 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/124 • 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.	0.81% 1/124 • Number of events 1 • 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.
Vascular disorders Peripheral artery aneurysm	0.81% 1/124 • Number of events 1 • 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.	0.00% 0/124 • 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.