Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: AZD7442

Detailed Description

SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September 2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective interventions to prevent or treat COVID-19 remain limited in number and clinical experience is limited. Clinical management is limited to supportive care, consequently overwhelming resources of healthcare systems around the world. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 S protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to prevent and/or treat COVID-19. There is currently one completed and 2 ongoing Phase I studies with AZD7442.

-The Provent repeat dose open-label sub-study is initiated to assess the safety, PK and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the Provent study who may benefit from repeat dose of AZD7442.

• Study Type: Interventional
• Enrollment (Actual): 5197
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Alken, Belgium, 3570
    • Research Site
  • Bruxelles, Belgium, 1000
    • Research Site
  • Gozée, Belgium, 6534
    • Research Site
  • Namur, Belgium, 5101
    • Research Site
  • Wetteren, Belgium, 9230
    • Research Site
• France
  • Clermont-Ferrand cedex, France, 63003
    • Research Site
  • Dijon cedex, France, 21079
    • Research Site
  • La Roche S/ Yon Cedex 9, France, 85925
    • Research Site
  • Lille, France, 59037
    • Research Site
  • Limoges cedex, France, 87000
    • Research Site
  • Nantes Cedex 1, France, 44093
    • Research Site
  • Paris cedex 10, France, 75475
    • Research Site
  • Paris cedex 14, France, 75679
    • Research Site
  • Saint Etienne Cedex 2, France, 42055
    • Research Site
  • Tours cedex 9, France, 37044
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Marbella (Málaga), Spain, 29603
    • Research Site
  • Pozuelo de Alarcón, Spain, 28223
    • Research Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Research Site
  • Enfield, United Kingdom, EN3 4GS
    • Research Site
  • Hayle, United Kingdom, TR27 5DT
    • Research Site
  • London, United Kingdom, WC1N 3BG
    • Research Site
  • Preston, United Kingdom, PR1 6YA
    • Research Site
  • Rochdale, United Kingdom, OL11 4AU
    • Research Site
  • Salford, United Kingdom, M6 8HD
    • Research Site
  • Torpoint, United Kingdom, PL11 2TB
    • Research Site
  • Wakefield, United Kingdom, WF1 5RH
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Research Site
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Cerritos, California, United States, 90703
      • Research Site
    • Fresno, California, United States, 93720
      • Research Site
    • Garden Grove, California, United States, 92844
      • Research Site
    • Huntington Beach, California, United States, 92647
      • Research Site
    • Lancaster, California, United States, 93534
      • Research Site
    • Modesto, California, United States, 95350
      • Research Site
    • Victorville, California, United States, 92394
      • Research Site
    • Westminster, California, United States, 92683
      • Research Site
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • Research Site
    • Middlebury, Connecticut, United States, 06762
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Coral Springs, Florida, United States, 33071
      • Research Site
    • Hollywood, Florida, United States, 33024
      • Research Site
    • Lauderdale Lakes, Florida, United States, 33313
      • Research Site
    • Miami, Florida, United States, 33125
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • Research Site
    • Pompano Beach, Florida, United States, 33064
      • Research Site
    • Wesley Chapel, Florida, United States, 33545
      • Research Site
    • West Palm Beach, Florida, United States, 33409
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Research Site
    • Columbus, Georgia, United States, 31904
      • Research Site
    • Conyers, Georgia, United States, 30094
      • Research Site
    • Marietta, Georgia, United States, 30060
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96859
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Research Site
    • Hazel Crest, Illinois, United States, 60429
      • Research Site
    • Quincy, Illinois, United States, 62301
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Research Site
    • Noblesville, Indiana, United States, 46060
      • Research Site
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Research Site
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Research Site
    • Minneapolis, Minnesota, United States, 55435
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Jamaica, New York, United States, 11432
      • Research Site
    • Ridgewood, New York, United States, 11385
      • Research Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Texas
    • Austin, Texas, United States, 78751
      • Research Site
    • El Paso, Texas, United States, 79935
      • Research Site
    • El Paso, Texas, United States, 79925
      • Research Site
    • Houston, Texas, United States, 77054
      • Research Site
    • San Antonio, Texas, United States, 78251
      • Research Site
    • San Antonio, Texas, United States, 78215
      • Research Site
    • Shenandoah, Texas, United States, 77384
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Research Site
  • Utah
    • Layton, Utah, United States, 84041
      • Research Site
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Research Site
    • Chesapeake, Virginia, United States, 23320
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98402
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥ 18 years of age at the time of signing the informed consent
2. Can benefit from passive immunization with antibodies
3. Medically stable
4. Negative result from point of care SARS-CoV-2 serology testing at screening
5. Contraceptive used by women of child bearing potential, condom used by men
6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Sub-study Inclusion criteria which are additional to those in parent study are as follows:

• The participant has been randomized, dosed, and is ongoing in the PROVENT parent study and is 12±2 months post first dose of blinded IMP.

• If one or more of the following apply:

  1. Immunocompromised and/or may be at increased risk for an inadequate immune response to a COVID-19 vaccine.
  2. In the opinion of the Investigator, are at increased risk and would benefit from a repeat dose of AZD7442.
• Documented negative SARS-CoV-2 RT-PCR test collected ≤ 3 days prior to sub-study Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.

Exclusion Criteria:

1. Significant infection or other acute illness, including fever >100°F (>37.8°C) on the day prior to or day of randomization.
2. History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening.
3. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
4. Known history of allergy or reaction to any component of the study drug formulation.
5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
6. Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow-up.
7. Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture.
8. Any other significant disease, disorder, or finding. that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
9. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study
10. Currently pregnant or breastfeeding.
11. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
12. Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD7442 program,, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
13. In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded.

Sub-study Exclusion criteria are as follows:

1. Patient have received a COVID-19 vaccination ≤ 14 days before sub-study Day1 or plan to receive a COVID-19 vaccination ≤ 14 days after sub-study Day1. (Such participants can subsequently be included in the study once they have reached >14 days after their last dose of vaccine).
2. Patient have two or more untreated cardiac risk factors or suspected unstable cardiac disease.
3. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD7442; Approximately 5150 participants will be randomized in a 2:1 ratio • Arm 1 (n=approximately 3433) will receive a single dose (× 2IM injections) of 300 mg of AZD7442	Drug: AZD7442; Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.; Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366; Other Names: Combination of 2mAbs(AZD8895 and AZD1061)
Placebo Comparator: Placebo; Approximately 5150 participants will be randomized in a 2:1 ratio • Arm 2 (n=approximately 1717) will receive saline placebo	Drug: Placebo; Single dose (× 2IM injections) of saline placebo on parent study Day 1.
Experimental: Sub-study AZD7442 Arm 1; Approximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 1 (~ 12 month repeat dose interval): Participants who received AZD7442 300 mg IM on Day 1 of the parent study will receive a second dose of AZD7442 300mg IM on sub-study Day 1.	Drug: AZD7442; Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.; Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366; Other Names: Combination of 2mAbs(AZD8895 and AZD1061)
Experimental: Sub-study AZD7442 Arm 2; Approximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 2(~ 6 month repeat dose interval): Participants who received placebo on Day 1 of the parent study will receive their first dose of AZD7442 300mg IM on sub-study Day1 followed by a second dose on sub-study Day 183.	Drug: AZD7442; Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.; Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366; Other Names: Combination of 2mAbs(AZD8895 and AZD1061)
Experimental: Sub-study AZD7442 Arm 3; A subset of Arm 1 and Arm 2 participants who will receive additional doses of AZD7442, 600mg, at Day 183 and Day 366 of the sub-study.	Drug: AZD7442; Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.; Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.; Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366; Other Names: Combination of 2mAbs(AZD8895 and AZD1061)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.	165 Days for primary analysis, 183 days for final analysis
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP	To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo	457 Days, Final analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection	366 days
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19	366 Days
The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits	366 days
Serum AZD7442 Concentrations, PK Parameters if Data Permit.	To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM	457 days
Incidence of ADA to AZD7442 in Serum	To evaluate ADA responses to AZD7442 in serum	457 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis	To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo	165 Days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: IQVIA Pty Ltd
• Investigators: Principal Investigator: Myron Levin, MD, AstraZeneca

Publications and helpful links

General Publications

• Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
• Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
• Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.
• CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html. Published 2020. Accessed 01 July 2020.
• Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.
• Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, de Thurah A, Landewe RB, Molto A, Muller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, Elkayam O. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882. Epub 2019 Aug 14.
• Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.
• Lamb EJ, Levey AS, Stevens PE. The Kidney Disease Improving Global Outcomes (KDIGO) guideline update for chronic kidney disease: evolution not revolution. Clin Chem. 2013 Mar;59(3):462-5. doi: 10.1373/clinchem.2012.184259. No abstract available.
• Poland GA, Ovsyannikova IG, Kennedy RB. Personalized vaccinology: A review. Vaccine. 2018 Aug 28;36(36):5350-5357. doi: 10.1016/j.vaccine.2017.07.062. Epub 2017 Jul 31.
• Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.
• Wagner A, Weinberger B. Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives. Front Immunol. 2020 Apr 23;11:717. doi: 10.3389/fimmu.2020.00717. eCollection 2020.
• WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.
• WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.
• Zimmermann P, Curtis N. Factors That Influence the Immune Response to Vaccination. Clin Microbiol Rev. 2019 Mar 13;32(2):e00084-18. doi: 10.1128/CMR.00084-18. Print 2019 Mar 20.
• Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.
• Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.
• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
• Morand EF, Furie RA. Anifrolumab in Systemic Lupus Erythematosus. Reply. N Engl J Med. 2020 Apr 23;382(17):1666. doi: 10.1056/NEJMc2002191. No abstract available.
• Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum In: N Engl J Med. 2020 Aug 13;383(7):698. doi: 10.1056/NEJMx200019.
• Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z.

Helpful Links

• CSP redacted
• SAP redacted
• CSR synopsis redacted

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2020
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pre-exposure Prophylaxis of COVID-19
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Anti-Infective Agents; Antiviral Agents; Cilgavimab and tixagevimab drug combination
• Other Study ID Numbers: D8850C00002; 2020-004356-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No