A study to evaluate the safety and tolerability of AZD7442 in Chinese Adults

Study identifier:D8850C00008

ClinicalTrials.gov identifier:NCT05184062

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase II double-blind, Placebo-controlled study to evaluate the safety and tolerability of AZD7442 in Chinese Adults

Medical condition

Coronavirus disease 2019 (COVID-19)

Phase

Phase 2

Healthy volunteers

Study drug

600 mg AZD7442 IV, 600mg placebo IV

Sex

All

Actual Enrollment

272

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 03 Dec 2021

Primary Completion Date: 15 Aug 2022

Study Completion Date: 06 May 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Xuzhou, China, 221000

Location

Research Site

chongqing, China, 400016

Location

Research Site

Shanghai, China, 200040

Location

Research Site

Changsha, China, 410008

Location

Research Site

Urumqi, China, 830054

Location

Research Site

hangzhou, China, 310006

Location

Research Site

baoding, China, 071000

Location

Research Site

Suzhou, China, 215004

Arms	Assigned Interventions
Experimental: AZD7442 co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.	Drug: 600 mg AZD7442 IV Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion. Other Name: AZD7442
Placebo Comparator: Placebo co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.	Drug: 600mg placebo IV Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion. Other Name: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV
Placebo	Placebo Group

Participant Flow: Overall Study

	AZD7442	Placebo
STARTED	202^[1]	70
COMPLETED	196	69
NOT COMPLETED	6	1
Lost to Follow-up	5	1
Withdrawal by Subject	1	0

[1]	The study consists of 3 periods: Screening period: Days -28 through -1 (up to 28 days), Intervention period: Day 1, randomisation and dosing, Safety follow-up period: Days 2 through 451 (450 days).

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV
Placebo	Placebo Group

Baseline Measures

	AZD7442	Placebo	Total
Number of Participants [units: Participants]	202	70	272
Sex: Female, Male [units: Participants]
Female	62	22	84
Male	140	48	188
COVID-19 vaccination status [units: ]
No, non-vaccinated	98	34	132
Yes, vaccinated	104	36	140
Baseline Weight [units: kg] Mean ± Standard Deviation	67.26 ± 11.54	66.51 ± 9.91	67.07 ± 11.13
Age Continuous [units: Years] Mean ± Standard Deviation	33.67 ± 11.73	35.71 ± 12.05	34.2 ± 11.80
Age, Customized [units: Participants]
>60 years	12	4	16
18 - 44 years	170	54	224
45 -60 years	20	12	32
Baseline Height [units: cm] Mean ± Standard Deviation	167.50 ± 8.77	166.53 ± 7.78	167.25 ± 8.53
Baseline Body Mass Index [units: kg/m^2] Mean ± Standard Deviation	23.84 ± 3.14	23.91 ± 2.96	23.86 ± 3.09
Race/Ethnicity, Customized [units: Participants] Asian	202	70	272
Race/Ethnicity, Customized [units: Participants] Not Hispanic or Latino	202	70	272

Outcome Measures

1. Primary Outcome Measure: adverse events of special interest [ Time Frame: recorded from the time of signature of the ICF up to 245 days ]

Measure Type	Primary
Measure Name	adverse events of special interest
Measure Description	Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
Time Frame	recorded from the time of signature of the ICF up to 245 days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV
Placebo	Placebo Group

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	202	70
adverse events of special interest [units: ]	0	0

No statistical analysis provided for adverse events of special interest

2. Secondary Outcome Measure: Serum concentrations of AZD7442 over time [ Time Frame: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361. ]

Measure Type	Secondary
Measure Name	Serum concentrations of AZD7442 over time
Measure Description	Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics
Time Frame	recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received AZD7442 and had at least one quantifiable serum PK observation post-dose, with no important protocol deviations thought to impact the analysis of the PK data

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV

Measured Values

	AZD7442
Number of Participants Analyzed [units:participants]	202
Serum concentrations of AZD7442 over time [units: μg/mL] Mean (Standard Deviation)
pre-dose	0 (0)
Day 1	219.7 (37.81)
Day 8	136.1 (26.58)
Day 31	101.5 (19.99)
Day 61	74.60 (16.08)
Day 91	55.98 (12.82)
Day 181	28.92 (7.752)
Day 271	12.74 (4.186)
Day 361	5.858 (2.530)

No statistical analysis provided for Serum concentrations of AZD7442 over time

Serious Adverse Events

Time Frame	Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Additional Description	No text entered.

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV
Placebo	Placebo Group

Serious Adverse Events

AZD7442

Placebo

Total, serious adverse events

# participants affected / at risk

6/202 (2.97%)

3/70 (4.29%)

Respiratory, thoracic and mediastinal disorders

Nasal septum deviation¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Covid-19 pneumonia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Craniocerebral injury¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Thermal burn¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Eye disorders

Retinal detachment¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Laryngopharyngitis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Radius fracture¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Skin and subcutaneous tissue disorders

Drug eruption¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.0

Other Adverse Events

Time Frame	Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
AZD7442	AZD7442 600 mg IV
Placebo	Placebo Group

Other Adverse Events

AZD7442

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

144/202 (71.29%)

58/70 (82.86%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/202 (0.50%)

2/70 (2.86%)

# events

Reproductive system and breast disorders

Abnormal uterine bleeding¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Reproductive system and breast disorders

Menstruation delayed¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

7/202 (3.47%)

2/70 (2.86%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

6/202 (2.97%)

1/70 (1.43%)

# events

Skin and subcutaneous tissue disorders

Acne¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Skin and subcutaneous tissue disorders

Dermatitis allergic¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Enteritis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

1/202 (0.50%)

2/70 (2.86%)

# events

Skin and subcutaneous tissue disorders

Skin exfoliation¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Gastritis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Haemorrhoidal haemorrhage¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Haemorrhoids¹,^†

# participants affected / at risk

3/202 (1.49%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Lip blister¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Mouth ulceration¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Noninfective gingivitis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Tooth impacted¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

3/202 (1.49%)

0/70 (0.00%)

# events

Blood and lymphatic system disorders

Eosinophilia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Discomfort¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

1/202 (0.50%)

2/70 (2.86%)

# events

General disorders and administration site conditions

Infusion site oedema¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Infusion site swelling¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Malaise¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

7/202 (3.47%)

2/70 (2.86%)

# events

Hepatobiliary disorders

Cholelithiasis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Cardiac disorders

Nodal rhythm¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Hepatobiliary disorders

Hepatic function abnormal¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Hepatobiliary disorders

Hyperbilirubinaemia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Immune system disorders

Drug hypersensitivity¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Immune system disorders

Hypersensitivity¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Immune system disorders

Seasonal allergy¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Asymptomatic bacteriuria¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Cervicitis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Cardiac disorders

Sinus bradycardia¹,^†

# participants affected / at risk

3/202 (1.49%)

0/70 (0.00%)

# events

Infections and infestations

Erysipelas¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Infections and infestations

Folliculitis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Gingivitis¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Infections and infestations

Herpes simplex¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

3/202 (1.49%)

4/70 (5.71%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Pericoronitis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Infections and infestations

Respiratory tract infection¹,^†

# participants affected / at risk

4/202 (1.98%)

1/70 (1.43%)

# events

Ear and labyrinth disorders

Otolithiasis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Infections and infestations

Tinea cruris¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Infections and infestations

Tonsillitis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

29/202 (14.36%)

13/70 (18.57%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Animal bite¹,^†

# participants affected / at risk

2/202 (0.99%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Heat stroke¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Joint dislocation¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Eye disorders

Keratitis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Limb injury¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Mouth injury¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Skin abrasion¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Subcutaneous haematoma¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

4/202 (1.98%)

0/70 (0.00%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Investigations

Blood bilirubin increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Blood creatine phosphokinase increased¹,^†

# participants affected / at risk

8/202 (3.96%)

3/70 (4.29%)

# events

Investigations

Blood glucose increased¹,^†

# participants affected / at risk

4/202 (1.98%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

3/202 (1.49%)

0/70 (0.00%)

# events

Investigations

Blood pressure increased¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Investigations

Blood urine present¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Investigations

C-reactive protein increased¹,^†

# participants affected / at risk

4/202 (1.98%)

2/70 (2.86%)

# events

Investigations

Gamma-glutamyltransferase increased¹,^†

# participants affected / at risk

3/202 (1.49%)

0/70 (0.00%)

# events

Investigations

Lymphocyte count decreased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Monocyte count increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Neutrophil count decreased¹,^†

# participants affected / at risk

1/202 (0.50%)

2/70 (2.86%)

# events

Investigations

Neutrophil count increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Platelet count increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Protein urine present¹,^†

# participants affected / at risk

15/202 (7.43%)

9/70 (12.86%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Qrs axis abnormal¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Bile acids increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

0/202 (0.00%)

3/70 (4.29%)

# events

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Metabolism and nutrition disorders

Hyperphagia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

2/202 (0.99%)

2/70 (2.86%)

# events

Musculoskeletal and connective tissue disorders

Groin pain¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal discomfort¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

0/202 (0.00%)

2/70 (2.86%)

# events

Gastrointestinal disorders

Aphthous ulcer¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

3/202 (1.49%)

1/70 (1.43%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

5/202 (2.48%)

4/70 (5.71%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Renal and urinary disorders

Albuminuria²,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Renal and urinary disorders

Calculus urinary¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

2/202 (0.99%)

2/70 (2.86%)

# events

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

2/202 (0.99%)

0/70 (0.00%)

# events

Renal and urinary disorders

Urine abnormality¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Glossodynia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Cystic lung disease¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary mass¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

4/202 (1.98%)

0/70 (0.00%)

# events

Skin and subcutaneous tissue disorders

Seborrhoeic alopecia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Blood and lymphatic system disorders

Lymphadenopathy¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Blood and lymphatic system disorders

Thrombocytosis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

General disorders

Chest pain¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

General disorders

Influenza like illness¹,^†

# participants affected / at risk

20/202 (9.90%)

4/70 (5.71%)

# events

Hepatobiliary disorders

Gallbladder polyp¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Hepatobiliary disorders

Hepatic calcification¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Cardiac disorders

Supraventricular tachycardia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Cardiac disorders

Ventricular extrasystoles¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

COVID-19¹,^†

# participants affected / at risk

58/202 (28.71%)

20/70 (28.57%)

# events

Infections and infestations

COVID-19 pneumonia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Infections and infestations

Hordeolum¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Infection parasitic¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Otitis media¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Pelvic inflammatory disease¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

2/202 (0.99%)

1/70 (1.43%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Infections and infestations

Suspected COVID-19¹,^†

# participants affected / at risk

12/202 (5.94%)

14/70 (20.00%)

# events

Ear and labyrinth disorders

Vertigo¹,^†

# participants affected / at risk

0/202 (0.00%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

1/202 (0.50%)

1/70 (1.43%)

# events

Injury, poisoning and procedural complications

Joint injury¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Injury, poisoning and procedural complications

Scratch¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Eye disorders

Cataract¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Electrocardiogram T wave abnormal¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Investigations

Myocardial necrosis marker increased¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Investigations

Ultrasound liver abnormal¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Investigations

Red blood cell count decreased¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Investigations

White blood cells urine positive¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Glucose tolerance impaired¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Hypertriglyceridaemia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Metabolism and nutrition disorders

Hyperuricaemia¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Psychiatric disorders

Alcoholism¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Psychiatric disorders

Sleep disorder¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Renal and urinary disorders

Pollakiuria¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Reproductive system and breast disorders

Balanoposthitis¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Congenital, familial and genetic disorders

Type V hyperlipidaemia¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Endocrine disorders

Hyperadrenocorticism¹,^†

# participants affected / at risk

0/202 (0.00%)

1/70 (1.43%)

# events

Endocrine disorders

Hyperthyroidism¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

Social circumstances

Alcohol use¹,^†

# participants affected / at risk

1/202 (0.50%)

0/70 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.0
2	Term from vocabulary, MedDRA 25.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	AstraZeneca Clinical Study Information Center
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

CSR_synopsis
Download
protocol_redacted
Download
SAP_redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR_synopsis

protocol_redacted

SAP_redacted

Trial Results Summaries