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Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

Primary Purpose

COVID-19, SARS-CoV-2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AZD1222

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 Vaccine

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD1222

Placebo

Arm Description

Approximately 20,000 participants randomized to the AZD1222 arm

Approximately 10,000 participants randomized to the saline placebo arm

Outcomes

Primary Outcome Measures

Number of Participants Achieving Binary Response

A binary response, whereby a participant with negative serostatus at baseline 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. The primary efficacy analysis was performed once approximately 150 events meeting the primary efficacy outcome measure definition had occurred across the AZD1222 and placebo groups.

Number of Participants With Adverse Events (AEs) Occurring Post Each Dose of Study Intervention

An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Occurring Throughout the Study

An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. AESIs were events of scientific and medical interest specific to the further understanding of the study intervention safety profile and required close monitoring and rapid communication by the investigators to the sponsor. MAAEs are defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy.

Secondary Outcome Measures

Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Occurring Post Second Dose of Study Intervention

The incidence of the first post-intervention response (negative at baseline to positive post intervention with study intervention) for SARS-CoV-2 nucleocapsid antibodies occurring ≥ 15 days post second dose of study intervention (key secondary endpoint).

Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Occurring Post Second Dose of Study Intervention

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 CDC criteria. Participant must present with at least one of the following symptoms per CDC criteria: fever, shortness of breath, difficulty breathing, chills, cough, fatigue, muscle aches, body aches, headache, new loss of taste, new loss of smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.

Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Occurring Post Second Dose of Study Intervention

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: new onset of fever (> 100 °Fahrenheit [> 37.8 °Celsius]), cough, shortness of breath, or anosmia/ageusia.

Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Occurring Post Second Dose of Study Intervention

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection (key secondary endpoint).

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Occurring Post Second Dose of Study Intervention

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death (key secondary endpoint).

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Occurring Post First Dose of Study Intervention

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring post first dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death.

Number of Participants With COVID-19-Related Emergency Department Visits Occurring Post Second Dose of Study Intervention

The incidence of COVID-19-related emergency department visits occurring ≥ 15 days post second dose of study intervention (key secondary endpoint).

Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to the S and RBD antigens of AZD1222 as measured by MSD serology assay is reported.

GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to SARS-CoV-2 neutralizing antibodies of AZD1222 as measured by pseudo-neutralization assay is reported.

Number of Participants With COVID-19 Symptomatic Illness Occurring Post First Dose of Study Intervention

The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention.

Full Information

NCT ID

NCT04516746

First Posted

August 17, 2020

Last Updated

March 10, 2023

Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04516746

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 28, 2020 (Actual)

Primary Completion Date

March 5, 2021 (Actual)

Study Completion Date

February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, SARS-CoV-2

Keywords

COVID-19 Vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to one of two or more groups in parallel for the duration of the study.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blind: two or more parties are unaware of the intervention assignment.

Allocation

Randomized

Enrollment

32459 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZD1222

Arm Type

Experimental

Arm Description

Approximately 20,000 participants randomized to the AZD1222 arm

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Approximately 10,000 participants randomized to the saline placebo arm

Intervention Type

Biological

Intervention Name(s)

AZD1222

Intervention Description

AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Commercially available 0.9% (n/V) saline for injection.

Primary Outcome Measure Information:

Title

Number of Participants Achieving Binary Response

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With Adverse Events (AEs) Occurring Post Each Dose of Study Intervention

Description

Time Frame

From Day 1 up to 28 days post second dose of study intervention, approximately 57 days

Title

Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Occurring Throughout the Study

Description

Time Frame

From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks

Title

Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

Description

Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy.

Time Frame

From Day 1 up to 7 days post each dose of study intervention, approximately 14 days

Secondary Outcome Measure Information:

Title

Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Occurring Post Second Dose of Study Intervention

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Occurring Post Second Dose of Study Intervention

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Occurring Post Second Dose of Study Intervention

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Occurring Post Second Dose of Study Intervention

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Occurring Post Second Dose of Study Intervention

Description

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Occurring Post First Dose of Study Intervention

Description

Time Frame

From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks

Title

Number of Participants With COVID-19-Related Emergency Department Visits Occurring Post Second Dose of Study Intervention

Description

The incidence of COVID-19-related emergency department visits occurring ≥ 15 days post second dose of study intervention (key secondary endpoint).

Time Frame

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Title

Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

Description

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

Description

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

Description

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Description

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Description

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

Description

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to SARS-CoV-2 neutralizing antibodies of AZD1222 as measured by pseudo-neutralization assay is reported.

Time Frame

Baseline (Day 1) and Days 15, 29, 43, and 57

Title

Number of Participants With COVID-19 Symptomatic Illness Occurring Post First Dose of Study Intervention

Description

The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention.

Time Frame

From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Falsey, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Magda Sobieszczyk, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

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United States

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Research Site

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Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

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United States

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Little Rock

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Arkansas

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72212

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United States

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Berkeley

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California

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94705

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United States

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El Centro

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California

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92243

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United States

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Los Angeles

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California

ZIP/Postal Code

90033

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United States

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Los Angeles

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California

ZIP/Postal Code

90095

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United States

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Research Site

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San Diego

State/Province

California

ZIP/Postal Code

92103

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United States

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San Diego

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California

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92134

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United States

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San Francisco

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California

ZIP/Postal Code

94102

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United States

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San Francisco

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California

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94158

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United States

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Torrance

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California

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90502

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United States

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Denver

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Colorado

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80204

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United States

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Danbury

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Connecticut

ZIP/Postal Code

06810

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United States

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Coral Gables

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Florida

ZIP/Postal Code

33134

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United States

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Lake Worth

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Florida

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33462

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United States

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Miami Lakes

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Florida

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33016

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Orlando

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Florida

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32803

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United States

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Honolulu

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Hawaii

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96814

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United States

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Meridian

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Idaho

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83642

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United States

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Chicago

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Illinois

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60612

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United States

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Indianapolis

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Indiana

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46202

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United States

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Ankeny

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Iowa

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50023

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United States

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Fairway

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Kansas

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66205

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United States

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Kansas City

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Kansas

ZIP/Postal Code

66160

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United States

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Wichita

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Kansas

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67207

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United States

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Wichita

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Kansas

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67214

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United States

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Lexington

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Kentucky

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40509

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United States

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Lake Charles

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Louisiana

ZIP/Postal Code

70601

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United States

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Monroe

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Louisiana

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71201

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United States

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Baltimore

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21201

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United States

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Baltimore

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21205

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United States

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Bethesda

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Maryland

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20889

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Boston

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Massachusetts

ZIP/Postal Code

02111

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Boston

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Massachusetts

ZIP/Postal Code

02215

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Ann Arbor

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Michigan

ZIP/Postal Code

48109

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Royal Oak

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Michigan

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48073

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Minneapolis

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55425

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Gulfport

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Mississippi

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39503

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Butte

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Montana

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59701

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Portsmouth

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New Hampshire

ZIP/Postal Code

03801

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Berlin

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New Jersey

ZIP/Postal Code

08009

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Albuquerque

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New Mexico

ZIP/Postal Code

87102

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Bronx

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New York

ZIP/Postal Code

10467

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Brooklyn

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New York

ZIP/Postal Code

11220

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Mineola

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New York

ZIP/Postal Code

11501

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United States

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New York

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New York

ZIP/Postal Code

10010

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New York

State/Province

New York

ZIP/Postal Code

10016

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United States

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New York

State/Province

New York

ZIP/Postal Code

10032

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United States

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Rochester

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New York

ZIP/Postal Code

14621

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United States

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Rochester

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New York

ZIP/Postal Code

14642

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United States

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Valhalla

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New York

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10595

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Durham

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North Carolina

ZIP/Postal Code

27710

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Cincinnati

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Ohio

ZIP/Postal Code

45229

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United States

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Columbus

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Ohio

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43210

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United States

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Yukon

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Oklahoma

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73099

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Portland

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Oregon

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97239

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Pittsburgh

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15232

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Warwick

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Rhode Island

ZIP/Postal Code

02886

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United States

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Charleston

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South Carolina

ZIP/Postal Code

29425

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United States

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North Charleston

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South Carolina

ZIP/Postal Code

29406

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United States

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Spartanburg

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South Carolina

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29303

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Knoxville

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37920

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United States

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Nashville

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Tennessee

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37203

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United States

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Austin

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Texas

ZIP/Postal Code

78745

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United States

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Dallas

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Texas

ZIP/Postal Code

75208

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United States

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Fort Sam Houston

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Texas

ZIP/Postal Code

78234

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United States

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Houston

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Texas

ZIP/Postal Code

77030

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United States

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McAllen

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Texas

ZIP/Postal Code

78504

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United States

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San Antonio

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Texas

ZIP/Postal Code

78236

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United States

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Spring

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Texas

ZIP/Postal Code

77381

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United States

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West Jordan

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Utah

ZIP/Postal Code

84088

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United States

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Burlington

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Vermont

ZIP/Postal Code

05401

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United States

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Fort Belvoir

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Virginia

ZIP/Postal Code

22060

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United States

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Richmond

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Virginia

ZIP/Postal Code

23226

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United States

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Seattle

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Washington

ZIP/Postal Code

98109

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South Charleston

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West Virginia

ZIP/Postal Code

25309

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United States

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Madison

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Wisconsin

ZIP/Postal Code

53792-5666

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United States

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Quillota

ZIP/Postal Code

2260000

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Chile

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Santiago

ZIP/Postal Code

7500539

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Chile

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Santiago

ZIP/Postal Code

8380453

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Chile

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Callao

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Peru

Facility Name

Research Site

City

Cercado De Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

15036

Country

Peru

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8110C00001&attachmentIdentifier=58e8ea47-f2dc-4d66-bdba-535e1b50a3a3&fileName=D8110C00001_SAP_Redacted.pdf&versionIdentifier=

Description

Statistical Analysis Plan (SAP)

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8110C00001&attachmentIdentifier=90924b91-95c6-4d19-94f1-d5e77e059c8d&fileName=D8110C00001_CSP_Amendment_6_Redacted.pdf&versionIdentifier=

Description

D8110C00001-CSP-amendment-6_Redacted.pdf

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8110C00001&attachmentIdentifier=a07258a5-fe26-409c-a940-ae25552c538b&fileName=D8110C00001_Clinical_Study_Report_Synopsis_Redacted.pdf&versionIdentifier=

Description

CSR Synopsis

Learn more about this trial

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

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Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

COVID-19, SARS-CoV-2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial