ClinicalTrials.gov

History of Changes for Study: NCT04516746
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Latest version (submitted July 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 17, 2020 None (earliest Version on record)
2 October 29, 2020 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Eligibility, Arms and Interventions and Study Design
3 November 11, 2020 Contacts/Locations and Study Status
4 December 1, 2020 Study Status, Contacts/Locations and Study Design
5 January 11, 2021 Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions and Study Design
6 February 22, 2021 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Study Design and Study Identification
7 March 8, 2021 Study Status and Outcome Measures
8 April 12, 2021 Study Status and Contacts/Locations
9 July 1, 2021 Study Status and Contacts/Locations
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Changes (Merged) for Study: NCT04516746
August 17, 2020 (v1) -- October 29, 2020 (v2)

Changes in: Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: D8110C00001
Brief Title: Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2020 October 2020
Overall Status: Not yet Recruiting
Study Start: August 17 28, 2020
Primary Completion: December 2 22, 2020 [Anticipated]
Study Completion: October 5 25, 2022 [Anticipated]
First Submitted: August 17, 2020
First Submitted that
Met QC Criteria:
August 17, 2020
First Posted: August 18, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 17, 2020 October 29, 2020
Last Update Posted: August 18 October 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators: Iqvia Pty Ltd
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.
Detailed Description: The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no specific treatments available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.
Open or close this module Conditions
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19 Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Participants are assigned to one of two or more groups in parallel for the duration of the study.
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30000 40051 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: AZD1222
2 IM doses of 5 × 10^10 vp (nominal, ± 1.5 × 10^10 vp) AZD1222 4 weeks apart
Biological: AZD1222
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart AZD12222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.
Placebo Comparator: Placebo
2 IM doses of saline placebo 4 weeks apart
Biological: Placebo
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart Commercially available 0.9% (n/V) saline for injection.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To estimate The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age
[ Time Frame: 1 year ]

A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs

≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.

2. To assess The safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age
[ Time Frame: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730. ]

  1. Incidence of adverse events.
  2. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
3. To assess The reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age (Substudy only)
[ Time Frame: 7 days post each dose of study intervention. ]

Incidence of local and systemic solicited adverse events.
Secondary Outcome Measures:
1. To estimate The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of SARS-CoV-2 asymptomatic infection
[ Time Frame: 1 year ]

The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.
2. To estimate The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of symptomatic COVID-19 using CDC criteria
[ Time Frame: 1 year ]

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using CDC criteria from the CDC.
3. To estimate The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of University of Oxford defined symptomatic COVID-19
[ Time Frame: 1 year ]

The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria.
4. To estimate The efficacy of 2 IM doses of AZD 1222 12222 compared to placebo for the prevention of severe or critical symptomatic COVID-19.
[ Time Frame: 1 year ]

The incidence of SARS-CoV- 2 RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention.
5. To estimate The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19-related Emergency Department visits
[ Time Frame: 1 year ]

The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention
6. To assess Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or placebo (Substudy and Illness Visits only)
[ Time Frame: 28 days post each dose ]

Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)
7. To determine Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or placebo (Sub-study and Illness Visits only)
[ Time Frame: 28 days post each dose ]

Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 130 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Increased risk of SARS-CoV-2 infection
  • Medically stable

Exclusion Criteria:

  • confirmed or suspected immunosuppressive or immunodeficient state
  • significant disease, disorder, or finding
  • Prior or concomitant vaccine therapy for COVID-19
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Study Officials: Ann Falsey, MD
Principal Investigator
University of Rochester
Magda Sobieszczyk, MD
Principal Investigator
Columbia University
Locations: United States, Alabama
Research Site
[Recruiting]
Birmingham, Alabama, United States, 35294
United States, Arizona
Research Site
[Recruiting]
Phoenix, Arizona, United States, 85018
Research Site
[Recruiting]
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Research Site
[Not yet recruiting]
Little Rock, Arkansas, United States, 72212
United States, California
Research Site
[Not yet recruiting]
Berkeley, California, United States, 94705
Research Site
[Not yet recruiting]
El Centro, California, United States, 92243
United States, California
Research Site
[Recruiting]
Los Angeles, California, United States, 90095 90033
Research Site
[Not yet recruiting]
Los Angeles, California, United States, 90095
Research Site
[Recruiting]
San Diego, California, United States, 92103
Research Site
[Not yet recruiting]
San Diego, California, United States, 92134
Research Site
[Recruiting]
San Francisco, California, United States, 94102
Research Site
[Recruiting]
San Francisco, California, United States, 94158
Research Site
[Recruiting]
Torrance, California, United States, 90502
United States, Colorado
Research Site
[Recruiting]
Denver, Colorado, United States, 80204
Research Site
[Not yet recruiting]
Loveland, Colorado, United States, 80538
United States, Connecticut
Research Site
[Not yet recruiting]
Danbury, Connecticut, United States, 06810
United States, Florida
Research Site
[Recruiting]
Atlantis, Florida, United States, 33462
Research Site
[Recruiting]
Coral Gables, Florida, United States, 33134
Research Site
[Not yet recruiting]
Miami Lakes, Florida, United States, 33016
Research Site
[Recruiting]
Orlando, Florida, United States, 32803
United States, Georgia
Research Site
[Not yet recruiting]
Savannah, Georgia, United States, 31406
Research Site
[Suspended]
Stockbridge, Georgia, United States, 30281
United States, Hawaii
Research Site
[Recruiting]
Honolulu, Hawaii, United States, 96814
United States, Idaho
Research Site
[Recruiting]
Meridian, Idaho, United States, 83642
United States, Illinois
Research Site
[Recruiting]
Chicago, Illinois, United States, 60611
Research Site
[Recruiting]
Chicago, Illinois, United States, 60612
United States, Indiana
Research Site
[Recruiting]
Indianapolis, Indiana, United States, 46202
United States, Iowa
Research Site
[Not yet recruiting]
Ankeny, Iowa, United States, 50023
United States, Kansas
Research Site
[Recruiting]
Fairway, Kansas, United States, 66205
United States, Kansas
Research Site
[Recruiting]
Kansas City, Kansas, United States, 66160
Research Site
[Recruiting]
Wichita, Kansas, United States, 67207
Research Site
[Recruiting]
Wichita, Kansas, United States, 67214
United States, Kentucky
Research Site
[Recruiting]
Lexington, Kentucky, United States, 40509
United States, Louisiana
Research Site
[Recruiting]
Lake Charles, Louisiana, United States, 70601
Research Site
[Recruiting]
Monroe, Louisiana, United States, 71203 71201
United States, Maine
Research Site
[Not yet recruiting]
Portland, Maine, United States, 04102
United States, Maryland
Research Site
[Recruiting]
Baltimore, Maryland, United States, 21205
Research Site
[Not yet recruiting]
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Research Site
[Not yet recruiting]
Boston, Massachusetts, United States, 02111
Research Site
[Recruiting]
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site
[Recruiting]
Ann Arbor, Michigan, United States, 48109
Research Site
[Not yet recruiting]
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Research Site
[Recruiting]
Bloomington, Minnesota, United States, 55425
United States, Mississippi
Research Site
[Not yet recruiting]
Gulfport, Mississippi, United States, 39503
United States, Missouri
Research Site
[Recruiting]
Saint Louis, Missouri, United States, 63110
United States, Montana
Research Site
[Not yet recruiting]
Butte, Montana, United States, 59701
United States, Nebraska
Research Site
[Recruiting]
Omaha, Nebraska, United States, 68134
United States, Nevada
Research Site
[Recruiting]
Henderson, Nevada, United States, 89014
United States, New Hampshire
Research Site
[Not yet recruiting]
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Research Site
[Not yet recruiting]
Berlin, New Jersey, United States, 08009
United States, New Mexico
Research Site
[Recruiting]
Albuquerque, New Mexico, United States, 87102
United States, New York
Research Site
[Not yet recruiting]
Bronx, New York, United States, 10457
Research Site
[Not yet recruiting]
Bronx, New York, United States, 10467
Research Site
[Not yet recruiting]
Brooklyn, New York, United States, 11220
Research Site
[Not yet recruiting]
Mineola, New York, United States, 11501
United States, New York
Research Site
[Not yet recruiting]
New York, New York, United States, 10016 10010
Research Site
[Recruiting]
New York, New York, United States, 10032 10016
Research Site
[Not yet recruiting]
New York, New York, United States, 10016
Research Site
[Recruiting]
New York, New York, United States, 10032
Research Site
[Recruiting]
Rochester, New York, United States, 14621
Research Site
[Not yet recruiting]
Rochester, New York, United States, 14642 14621
Research Site
[Recruiting]
Rochester, New York, United States, 14642
Research Site
[Recruiting]
Valhalla, New York, United States, 10595
United States, North Carolina
Research Site
[Recruiting]
Durham, North Carolina, United States, 27710
United States, North Dakota
Research Site
[Not yet recruiting]
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
[Recruiting]
Cincinnati, Ohio, United States, 45229
Research Site
[Recruiting]
Columbus, Ohio, United States, 43205
Research Site
[Recruiting]
Columbus, Ohio, United States, 43210
United States, Oklahoma
Research Site
[Recruiting]
Oklahoma City, Oklahoma, United States, 73114
United States, Oregon
Research Site
[Recruiting]
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Research Site
[Not yet recruiting]
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Research Site
[Recruiting]
Charleston, South Carolina, United States, 29406
Research Site
[Recruiting]
Charleston, South Carolina, United States, 29425
Research Site
[Recruiting]
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Research Site
[Not yet recruiting]
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Research Site
[Recruiting]
Knoxville, Tennessee, United States, 37920
Research Site
[Recruiting]
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
[Recruiting]
Austin, Texas, United States, 78745
Research Site
[Recruiting]
Dallas, Texas, United States, 75208
Research Site
[Recruiting]
Houston, Texas, United States, 77030
Research Site
[Not yet recruiting]
Lackland Air Force Base, Texas, United States, 78236
Research Site
[Recruiting]
McAllen, Texas, United States, 78504
Research Site
[Recruiting]
San Antonio, Texas, United States, 78229
Research Site
[Not yet recruiting]
San Antonio, Texas, United States, 78234
Research Site
[Recruiting]
The Woodlands, Texas, United States, 77381
United States, Utah
Research Site
[Recruiting]
West Jordan, Utah, United States, 84088
United States, Vermont
Research Site
[Not yet recruiting]
Burlington, Vermont, United States, 05401
United States, Virginia
Research Site
[Not yet recruiting]
Fort Belvoir, Virginia, United States, 22060
Research Site
[Recruiting]
Richmond, Virginia, United States, 23226
United States, Washington
Research Site
[Not yet recruiting]
Bellingham, Washington, United States, 98226
United States, Washington
Research Site
[Recruiting]
Seattle, Washington, United States, 98109 98104
Research Site
[Recruiting]
Seattle, Washington, United States, 98109
United States, West Virginia
Research Site
[Not yet recruiting]
South Charleston, West Virginia, United States, 25309
United States, Wisconsin
Research Site
[Recruiting]
Madison, Wisconsin, United States, 53792-5666
Chile
Research Site
[Not yet recruiting]
Quillota, Chile, 2260000
Research Site
[Not yet recruiting]
Region Metropolitana, Chile, 7550000
Research Site
[Not yet recruiting]
Santiago, Chile, 7500539
Research Site
[Not yet recruiting]
Santiago, Chile, 8380453
Peru
Research Site
[Not yet recruiting]
Callao, Peru, 0
Research Site
[Not yet recruiting]
Cercado De Lima, Peru, LIMA 1
Research Site
[Not yet recruiting]
Cercardo De Lima, Peru, LIMA 1
Research Site
[Not yet recruiting]
Lima, Peru, 15001
Research Site
[Not yet recruiting]
Lima, Peru, 33
Research Site
[Recruiting]
Lima, Peru, 7006
Research Site
[Not yet recruiting]
Lima, Peru, Lami 01
Research Site
[Not yet recruiting]
Lima, Peru, Lima 27
Research Site
[Not yet recruiting]
Lima, Peru, Lima04
Research Site
[Not yet recruiting]
Lima, Peru, Lima12
Research Site
[Not yet recruiting]
Lima, Peru, Lima32
Research Site
[Not yet recruiting]
Miraflores, Peru, 15046
Open or close this module IPDSharing
Plan to Share IPD: Yes
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
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
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
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Open or close this module References
Citations: 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.
FDA. (Food and Drug Administration). Guidance for Industry. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. . https://www.fda.gov/media/73679/download. Published 2007. Accessed 20 June 2020.
Folegatti PM, Bittaye M, Flaxman A, Lopez FR, Bellamy D, Kupke A, Mair C, Makinson R, Sheridan J, Rohde C, Halwe S, Jeong Y, Park YS, Kim JO, Song M, Boyd A, Tran N, Silman D, Poulton I, Datoo M, Marshall J, Themistocleous Y, Lawrie A, Roberts R, Berrie E, Becker S, Lambe T, Hill A, Ewer K, Gilbert S. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):816-826. doi: 10.1016/S1473-3099(20)30160-2. Epub 2020 Apr 21. Erratum in: Lancet Infect Dis. 2020 May 12;:. Lancet Infect Dis. 2020 Jun 8;:. PubMed 32325038
Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. Epub 2016 Aug 25. Review. PubMed 27578435
Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30. PubMed 32007145
SPEAC. (Safety Platform for Emergency Vaccines) D2.3 Priority list of adverse events of special interest: COVID-19. Work Package: WP2 Standards and Tools. v1.1. 05 March 2020. https://media.tghn.org/articles/COVID-19_AESIs_SPEAC_V1.1_5Mar2020.pdf. Published 2020. Accessed 14 June 2020.
van Doremalen N, Lambe T, Spencer A, Belij-Rammerstorfer S, Purushotham JN, Port JR, Avanzato VA, Bushmaker T, Flaxman A, Ulaszewska M, Feldmann F, Allen ER, Sharpe H, Schulz J, Holbrook M, Okumura A, Meade-White K, Pérez-Pérez L, Edwards NJ, Wright D, Bissett C, Gilbride C, Williamson BN, Rosenke R, Long D, Ishwarbhai A, Kailath R, Rose L, Morris S, Powers C, Lovaglio J, Hanley PW, Scott D, Saturday G, de Wit E, Gilbert SC, Munster VJ. ChAdOx1 nCoV-19 vaccine prevents SARS-CoV-2 pneumonia in rhesus macaques. Nature. 2020 Oct;586(7830):578-582. doi: 10.1038/s41586-020-2608-y. Epub 2020 Jul 30. Erratum in: Nature. 2021 Feb;590(7844):E24. PubMed 32731258
Waldrop G, Doherty M, Vitoria M, Ford N. Stable patients and patients with advanced disease: consensus definitions to support sustained scale up of antiretroviral therapy. Trop Med Int Health. 2016 Sep;21(9):1124-30. doi: 10.1111/tmi.12746. Epub 2016 Jul 22. PubMed 27371814
WHO. (World Health Organization) Coronavirus disease (COVID-19) situation report-175. 13 July 2020. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200713- covid-19-sitrep-175.pdf?sfvrsn=d6acef25_2. Published 2020. Accessed 13 July 2020.
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. Addendum: A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z. PubMed 33199918
Clinical Study Protocol - 1.0 AstraZeneca AZD1222 - D8110C00001 CONFIDENTIAL AND PROPRIETARY 92 of 92
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. New England Journal of Medicine. 2020;382(8):727-33. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159(7):702-6.
Links:
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