NCT04625972 (STORM CHASER) is a Phase 3 clinical trial of AZD7442 in COVID-19, sponsored by AstraZeneca.

Who is sponsoring NCT04625972?

NCT04625972 is sponsored by AstraZeneca.

What drugs are being tested in NCT04625972?

Interventions in NCT04625972: AZD7442, Placebo.

Is NCT04625972 still recruiting?

NCT04625972 is currently completed. Last updated 21 November 2023.

Are results published for NCT04625972?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-21 · How we verify

NCT04625972: STORM CHASER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults

Completed Phase 3 Results posted Last updated 21 November 2023

What this trial tests

Phase 3 trial testing AZD7442 in COVID-19 in 1,131 participants. Completed in 25 July 2022.

Timeline

2 December 2020

Primary endpoint
7 April 2021

25 July 2022

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,131
Start date	2 December 2020
Primary completion	7 April 2021
Estimated completion	25 July 2022
Sites	57 locations across United Kingdom, United States

Drugs / interventions tested

AZD7442 — full drug profile →
Placebo

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 120, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness Primary · Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19

Primary Analysis

Group	Value	95% CI
AZD7442	23
Placebo	17

Final analysis

Group	Value	95% CI
AZD7442	28
Placebo	24

AEs, SAEs, MAAEs, and AESIs Post Dose of IMP Primary · 457 Days

Any Adverse Event

Group	Value	95% CI
AZD7442	348
Placebo	193

Non-serious Adverse Event

Group	Value	95% CI
AZD7442	345
Placebo	191

Serious Adverse Events

Group	Value	95% CI
AZD7442	20
Placebo	16

Medically Attended Adverse Events

Group	Value	95% CI
AZD7442	95
Placebo	52

Adverse Events of Special Interest

Group	Value	95% CI
AZD7442	4
Placebo	4

The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP Secondary · 183 Days

Primary analysis

Group	Value	95% CI
AZD7442	0
Placebo	1

Final Analysis

Group	Value	95% CI
AZD7442	0
Placebo	1

The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies Secondary · 366 Days

Group	Value	95% CI
AZD7442	173
Placebo	98

The Incidence of COVID-19-related Death Occurring After Dosing With IMP Secondary · 366 Days

Group	Value	95% CI
AZD7442	0
Placebo	0

The Incidence of All-cause Mortality Occurring After Dosing With IMP Secondary · 366 Days

Group	Value	95% CI
AZD7442	3
Placebo	2

Serum AZD7442 Concentrations, PK Parameters Secondary · 457 Days

Day 8

Group	Value	95% CI
AZD7442	10.028	± 110.166

Day 29

Group	Value	95% CI
AZD7442	11.718	± 72.721

Day 58

Group	Value	95% CI
AZD7442	9.420	± 75.160

Day 92

Group	Value	95% CI
AZD7442	7.183	± 81.706

Day 183

Group	Value	95% CI
AZD7442	2.975	± 79.694

Day 366

Group	Value	95% CI
AZD7442	0.696	± 63.725

Incidence of ADA to AZD7442 in Serum Secondary · 457 Days

Group	Value	95% CI
AZD7442	110
Placebo	6

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AZD7442

Serious: 20/749 (3%)

Deaths: 3/749

Placebo

Serious: 16/372 (4%)

Deaths: 2/372

Serious adverse events (43 terms)

Reaction	System	AZD7442	Placebo
Covid-19 pneumonia	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Covid-19	Infections and infestations	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Osteomyelitis	Infections and infestations	—	—
Pyelonephritis acute	Infections and infestations	—	—
Cardiac arrest	Cardiac disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Cardiac failure	Cardiac disorders	—	—
Burns second degree	Injury, poisoning and procedural complications	—	—
Lumbar vertebral fracture	Injury, poisoning and procedural complications	—	—
Near drowning	Injury, poisoning and procedural complications	—	—
Overdose	Injury, poisoning and procedural complications	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—
Coronary artery disease	Cardiac disorders	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—
Toxicity to various agents	Injury, poisoning and procedural complications	—	—
Myocardial infarction	Cardiac disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Trisomy 21	Congenital, familial and genetic disorders	—	—
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (375 terms — click to expand)

Reaction	System	AZD7442	Placebo
Covid-19	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Fatigue	General disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Pain	General disorders	—	—
Chills	General disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Ageusia	Nervous system disorders	—	—
Anosmia	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
C-reactive protein increased	Investigations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—
Asymptomatic covid-19	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Malaise	General disorders	—	—
Bronchitis	Infections and infestations	—	—
Anxiety	Psychiatric disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Vaccination complication	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood glucose increased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Covid-19 pneumonia, Pneumonia, Cellulitis, Diabetic ketoacidosis, Covid-19, Acute myocardial infarction, Osteomyelitis, Pyelonephritis acute.

Data from ClinicalTrials.gov NCT04625972 adverse events section.

Sponsor's own description

This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Neutralizing monoclonal antibodies for treatment of COVID-19.
Taylor PC, Adams AC, Hufford MM, de la Torre I, et al · · 2021 · cited 604× · PMID 33875867 · DOI 10.1038/s41577-021-00542-x
Tackling COVID-19 with neutralizing monoclonal antibodies.
Corti D, Purcell LA, Snell G, Veesler D. · · 2021 · cited 300× · PMID 34087172 · DOI 10.1016/j.cell.2021.05.005
Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail.
Dong J, Zost SJ, Greaney AJ, Starr TN, et al · · 2021 · cited 274× · PMID 34548634 · DOI 10.1038/s41564-021-00972-2
Antibodies to watch in 2022.
Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
Molecular mechanism of interaction between SARS-CoV-2 and host cells and interventional therapy.
Zhang Q, Xiang R, Huo S, Zhou Y, et al · · 2021 · cited 219× · PMID 34117216 · DOI 10.1038/s41392-021-00653-w
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial.
Montgomery H, Hobbs FDR, Padilla F, Arbetter D, et al · · 2022 · cited 175× · PMID 35688164 · DOI 10.1016/s2213-2600(22)00180-1
Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection.
Hwang YC, Lu RM, Su SC, Chiang PY, et al · · 2022 · cited 170× · PMID 34983527 · DOI 10.1186/s12929-021-00784-w

Verify or expand the search:

Other trials of AZD7442

Trials testing the same drug.

NCT05281601 — AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics · Phase 1 · completed
NCT05166421 — Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD106 · Phase 1 · completed
NCT05780437 — AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) · Phase 3 · completed
NCT04723394 — Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults · Phase 3 · completed
NCT04625725 — Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. · Phase 3 · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04625972 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 21 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04625972.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing