Trial Outcomes & Findings for Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults (NCT NCT04723394)

Last Updated: 2023-07-05

Results Overview

Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 \< 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

910 participants

Primary outcome timeframe

Baseline (Day 1) and Day 29

Results posted on

2023-07-05

Participant Flow

910 participants were randomized to receive treatment in study D8851C00001 (TACKLE) with AZD7442 (AZD8895 + AZD1061) or placebo. Of the 910 participants randomized, 903 (99.2%) received treatment with study drug. Of the 903 dosed, 452 (50.1%) participants received AZD7442 and 451 (49.9%) participants received placebo.

In TACKLE, at the first visit, ie, the enrollment visit 1, participants were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrolment, eligible participants were randomized at a 1: 1 ratio to receive a single dose of study provided AZD7442 (AZD8895 + AZD1061) or placebo.

Participant milestones

Participant milestones
Measure	AZD7442 Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo Single dose of Placebo (2 separate IM injections) on Day 1
Overall Study STARTED	456	454
Overall Study Dosed	452	451
Overall Study Modified Full Analysis Set	413	421
Overall Study Primary Analysis Population	410	419
Overall Study Key Secondary Analysis Population	404	411
Overall Study COMPLETED	407	390
Overall Study NOT COMPLETED	49	64

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD7442 Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo Single dose of Placebo (2 separate IM injections) on Day 1
Overall Study Adverse Event	0	3
Overall Study Death	8	8
Overall Study Lost to Follow-up	20	17
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	20	34
Overall Study Participants withdrawn due to eligibility, eligibility, moving, and being randomized in error.	0	2

Baseline Characteristics

Full Analysis Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD7442 n=452 Participants Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo n=451 Participants Single dose of Placebo (2 separate IM injections) on Day 1	Total n=903 Participants Total of all reporting groups
Age, Continuous	46.3 Years STANDARD_DEVIATION 15.42 • n=5 Participants	45.9 Years STANDARD_DEVIATION 14.99 • n=7 Participants	46.1 Years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	239 Participants n=5 Participants • Full Analysis Set	216 Participants n=7 Participants • Full Analysis Set	455 Participants n=5 Participants • Full Analysis Set
Sex: Female, Male Male	213 Participants n=5 Participants • Full Analysis Set	235 Participants n=7 Participants • Full Analysis Set	448 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Hispanic or Latino	230 Participants n=5 Participants • Full Analysis Set	238 Participants n=7 Participants • Full Analysis Set	468 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Not Hispanic or Latino	222 Participants n=5 Participants • Full Analysis Set	213 Participants n=7 Participants • Full Analysis Set	435 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Not reported	21 Participants n=5 Participants • Full Analysis Set	21 Participants n=7 Participants • Full Analysis Set	42 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants • Full Analysis Set	0 Participants n=7 Participants • Full Analysis Set	0 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized American Indian or Alaska Native	100 Participants n=5 Participants • Full Analysis Set	115 Participants n=7 Participants • Full Analysis Set	215 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Asian	30 Participants n=5 Participants • Full Analysis Set	21 Participants n=7 Participants • Full Analysis Set	51 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants • Full Analysis Set	20 Participants n=7 Participants • Full Analysis Set	36 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants • Full Analysis Set	0 Participants n=7 Participants • Full Analysis Set	0 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Full Analysis Set	0 Participants n=7 Participants • Full Analysis Set	0 Participants n=5 Participants • Full Analysis Set
Race/Ethnicity, Customized White	285 Participants n=5 Participants • Full Analysis Set	274 Participants n=7 Participants • Full Analysis Set	559 Participants n=5 Participants • Full Analysis Set
BMI (kg/m^2)	28.9 kg/m^2 STANDARD_DEVIATION 5.46 • n=5 Participants	29.2 kg/m^2 STANDARD_DEVIATION 6.56 • n=7 Participants	29.0 kg/m^2 STANDARD_DEVIATION 6.03 • n=5 Participants
Risk of Progression to Severe COVID-19 High	405 Participants n=5 Participants	406 Participants n=7 Participants	811 Participants n=5 Participants
Risk of Progression to Severe COVID-19 Low	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Country Argentina	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Country Brazil	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Country Czech Republic	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Country Germany	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Country Hungary	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Country Italy	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Country Japan	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Country Mexico	139 Participants n=5 Participants	166 Participants n=7 Participants	305 Participants n=5 Participants
Country Poland	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Country Russian Federation	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants
Country Spain	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Country Ukraine	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Country United Kingdom	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Country United States	64 Participants n=5 Participants	40 Participants n=7 Participants	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 29

Population: Modified Full Analysis Set (mFAS) - All randomized participants who received IMP ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose. For AZD7442, N = 413; Placebo, N = 421. For the analysis of the primary endpoint, only participants within this population who were assessed for the primary endpoint were included in the analysis.

Outcome measures

Outcome measures
Measure	AZD7442 n=410 Participants Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo n=419 Participants Single dose of Placebo (2 separate IM injections) on Day 1
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29	18 Participants	37 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 169

Population: Modified Full Analysis Set (mFAS) - All randomized participants who received IMP \<= 7 days from symptom onset and were not hospitalized at baseline (\<= Day 1) for isolation purpose. For AZD7442, N = 413; Placebo, N = 421. For the analysis of the Key Secondary Endpoint, only participants within this population who were assessed for the primary endpoint were included in the analysis.

Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169

Outcome measures

Outcome measures
Measure	AZD7442 n=404 Participants Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo n=411 Participants Single dose of Placebo (2 separate IM injections) on Day 1
A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169	20 Participants	40 Participants

Adverse Events

AZD7442

Serious events: 46 serious events

Other events: 230 other events

Deaths: 8 deaths

Placebo

Serious events: 65 serious events

Other events: 224 other events

Deaths: 8 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 of any part or entirely of study results requires prior written approval from sponsor, with no timeframe for sponsor to review.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	AZD7442 n=452 participants at risk Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo n=451 participants at risk Single dose of Placebo (2 separate IM injections) on Day 1
Cardiac disorders Acute left ventricular failure	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Pneumonia bacterial	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Sinusitis	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Superinfection bacterial	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Blood and lymphatic system disorders Anaemia of malignant disease	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Death	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Sudden cardiac death	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Biliary colic	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Acute coronary syndrome	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholecystitis	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholecystitis chronic	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Appendicitis	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Bacterial diarrhoea	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Acute myocardial infarction	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations COVID-19	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	2.0% 9/451 • Number of events 9 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations COVID-19 pneumonia	5.1% 23/452 • Number of events 23 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	8.2% 37/451 • Number of events 37 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Cellulitis	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Disseminated tuberculosis	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Arrhythmia	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.44% 2/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Gastroenteritis viral	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Atrial fibrillation	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Pseudomonas infection	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Sepsis	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Infections and infestations Septic shock	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Cardiac arrest	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Cardiac failure	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Injury, poisoning and procedural complications Hip fracture	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Injury, poisoning and procedural complications Road traffic accident	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Myocardial ischaemia	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Musculoskeletal and connective tissue disorders Immobilisation syndrome	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Cardiac disorders Supraventricular extrasystoles	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Nervous system disorders Loss of consciousness	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.

Other adverse events
Measure	AZD7442 n=452 participants at risk Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1	Placebo n=451 participants at risk Single dose of Placebo (2 separate IM injections) on Day 1
Investigations Lipids abnormal	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Investigations Neutrophil count decreased	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Asthenia	1.8% 8/452 • Number of events 10 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	2.0% 9/451 • Number of events 9 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Chest discomfort	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Decreased activity	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Energy increased	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.44% 2/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Face oedema	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Fatigue	3.5% 16/452 • Number of events 16 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	3.3% 15/451 • Number of events 17 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Feeling hot	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Gait disturbance	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site bruising	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site erythema	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.44% 2/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site haematoma	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site induration	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site inflammation	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site nodule	0.22% 1/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site pain	1.8% 8/452 • Number of events 12 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	2.4% 11/451 • Number of events 15 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site swelling	0.22% 1/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Injection site warmth	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Malaise	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Pain	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Pyrexia	0.66% 3/452 • Number of events 4 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Suprapubic pain	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Vaccination site pain	0.66% 3/452 • Number of events 6 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.44% 2/451 • Number of events 3 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
General disorders Vaccination site reaction	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Biliary colic	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholecystitis	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholecystitis chronic	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholelithiasis	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Cholestasis	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Drug-induced liver injury	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Hepatic failure	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Hepatic steatosis	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.44% 2/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Hepatitis toxic	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Immune system disorders Allergy to arthropod sting	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Immune system disorders Drug hypersensitivity	0.00% 0/452 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Immune system disorders Hypersensitivity	0.22% 1/452 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.00% 0/451 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
Immune system disorders Seasonal allergy	0.44% 2/452 • Number of events 2 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.	0.22% 1/451 • Number of events 1 • From first dose of study drug until end of study, with an average of 436 days. AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.