Back to results

VA CoronavirUs Research and Efficacy Studies-1 (VACURES-1)

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Convalescent Plasma

Masked Saline Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring 2019 novel coronavirus disease, COVID-19 pandemic, COVID-19 virus infection, COVID-19 virus disease, Respiratory failure, Pneumonia, viral / therapy, Blood Component Transfusion, Severity of Illness Index, Survival Analysis, Treatment Outcome, Prospective Study, Humans, Adults, Male, Female, convalescent plasma, SARS CoV-2, COVID-19 convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Veterans must meet all of the following criteria to be eligible to participate:

Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection.
Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
Participant (or legally authorized representative) understands and agrees to comply with planned study procedures.
Veteran 18 years of age at time of screening.
Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or antigen test, as documented by either of the following:

(1)Reverse Transcription polymerase chain reaction (RT-PCR) or antigen positive (nasopharyngeal, oropharyngeal, saliva, lower respiratory) in sample collected 72 hours prior to screening; (2)RT-PCR or antigen positive in sample collected > 72 hours but 168 hours (i.e. 7 days) prior to screening, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.), AND progressive disease suggestive of ongoing SARS-CoV-2 infection.

6.Requiring oxygen by nasal cannula or by face-mask as a new treatment (or if previously on home oxygen, at a liter flow at least 2 Lpm greater than home prescription), but not on humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm.

7.Can be randomized within 72 hours of hospital admission. 8.Agrees not to participate in another therapeutic clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29 without approval from the investigator(s). Taking part in other research studies, including those unrelated to SARS-CoV-2, without first discussing it with the investigators of this study may invalidate the results of this study, as well as that of the other study.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Respiratory failure requiring mechanical ventilation, non-invasive ventilation including continuous positive airway pressure (CPAP) (for an indication other than previously diagnosed sleep apnea and maintained on outpatient settings), or extra-corporeal membrane oxygenation or anticipated to require any of those treatments or to die within 24 hours.
Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours.
History of previous transfusion reaction.
Previously documented serum immunoglobulin A (IgA) deficiency (<7 mg/dL)
Documented to have received convalescent plasma in the last 60 days.

Sites / Locations

Birmingham VA Medical Center, Birmingham, AL
Phoenix VA Health Care System, Phoenix, AZ
Rocky Mountain Regional VA Medical Center, Aurora, CO
North Florida/South Georgia Veterans Health System, Gainesville, FL
Orlando VA Medical Center, Orlando, FL
James A. Haley Veterans' Hospital, Tampa, FL
Atlanta VA Medical and Rehab Center, Decatur, GA
Edward Hines Jr. VA Hospital, Hines, IL
VA Ann Arbor Healthcare System, Ann Arbor, MI
John D. Dingell VA Medical Center, Detroit, MI
VA Southern Nevada Healthcare System, North Las Vegas, NV
James J. Peters VA Medical Center, Bronx, NY
Durham VA Medical Center, Durham, NC
Louis Stokes VA Medical Center, Cleveland, OH
Oklahoma City VA Medical Center, Oklahoma City, OK
VA Portland Health Care System, Portland, OR
Ralph H. Johnson VA Medical Center, Charleston, SC
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Michael E. DeBakey VA Medical Center, Houston, TX
South Texas Health Care System, San Antonio, TX
VA Salt Lake City Health Care System, Salt Lake City, UT
Hunter Holmes McGuire VA Medical Center, Richmond, VA
William S. Middleton Memorial Veterans Hospital, Madison, WI
VA Caribbean Healthcare System, San Juan, PR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Convalescent Plasma

Masked Saline Placebo

Arm Description

The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.

The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.

Outcomes

Primary Outcome Measures

Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death

Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.

Secondary Outcome Measures

Time (in Days) to Recovery

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the Modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement : 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy.

Time (in Days) to Death or Respiratory Failure

Defined as the first day on which the subject died from any cause or had respiratory failure. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.

Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm

Defined as the proportion of subjects who died from any cause, had respiratory failure, or who required humidified heater high-flow cannula (HHHFNC) at >= 15 Lpm. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.

Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm

Time to death or respiratory failure is defined as the first day on which the subject died from any cause, had respiratory failure (defined above), or who required HHHFNC at >= 15 Lpm.

Number of Participants With 28-day All-cause Mortality

Death for Any Reason

Time to an Improvement of at Least One Category Using an Ordinal Scale

Number of Days until the Modified WHO Clinical Status Improved by at Least One Category Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 8) Death. The higher the score, the worse the outcome.

Time to an Improvement of at Least Two Categories Using an Ordinal Scale

Number of Days until the Modified WHO Clinical Status Improved by at Least Two Categories Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.

Participant's Clinical Status by Ordinal Scale

Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.

Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28

Change in the Modified WHO Clinical Status Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.

Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28

Categorical Change in the Modified WHO 8-point Ordinal Scale for Clinical Improvement Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.

Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First

Number of Days until Initial Hospitalization Discharge or (NEWS2 <= 2 Maintained for at Least 22 Hours) The National Early Warning Score 2 (NEWS2) score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.

Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29

Change in NEWS2 The National Early Warning Score 2 (NEWS2) has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.

Duration of Hospitalization

Number of Days Hospitalized During Initial Hospitalization

Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason)

Number of participants for whom study product administration was discontinued or temporarily suspended for any reason

Full Information

NCT ID

NCT04539275

First Posted

August 27, 2020

Last Updated

September 9, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04539275

Brief Title

VA CoronavirUs Research and Efficacy Studies-1

Acronym

VACURES-1

Official Title

VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

DMC recommended early termination of enrollment

Study Start Date

November 16, 2020 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.

Detailed Description

As of August 25, 2020, SARS-Coronavirus 2 (SARS-CoV-2; COVID-19) infections are approaching 6 million persons and 180,000 deaths in the US. Of the 20% of patients admitted to hospital, up to half progress to ICU admission, respiratory failure or death. Prominent among these progressors are older men, particularly those with underlying comorbidities (e.g., hypertension, diabetes, lung, heart, kidney or liver disease, obesity and immunocompromised), all common among Veterans. There are no drugs or other therapeutics approved by the FDA to prevent or treat COVID-19 infection. Convalescent plasma therapy is being used empirically, although only five of six small uncontrolled case series (total n=56) in SARS-CoV-23-8 and a recent study with non-randomized controls suggest improved selected clinical, virologic and laboratory outcomes; outcomes in another small randomized trial were equivocal. For other infections, such as influenza and Ebola virus, promising observational studies were not reliably confirmed by controlled trials. In multiple infections, use of convalescent plasma has been distinguished by its safety profile but not by the consistency of its benefit. The current double-blind, placebo-controlled randomized clinical trial (RCT) is designed to determine definitively whether this intervention is effective in a population at high risk of complications and death from SARS-CoV-2 infection. The investigators compare the effect of convalescent plasma vs. saline placebo with a robust study design, adequate sample size and statistical and logistical rigor to assure that the interventions the investigators make to treat serious disease are well-validated to support its use or to move on to test other potentially safe and effective treatments. This study is taking place at approximately 25 Veterans Affairs (VA) Medical Centers located across the US. A participant's involvement will last up to 33 days. The entire study, from the date the first person enters until the last participant is seen, is expected to last about 20 months. Data collected for this study will be analyzed and stored at the Palo Alto Cooperative Studies Program Coordinating Center (CSPCC). After the study is completed, the de-identified, archived data will continue to be stored at the Palo Alto CSPCC, accessible for use by researchers including those outside of the study with an approved Data Use Agreement. The biospecimens collected in the study for current and future research will be kept at the VA Biorepository in Palo Alto, California unless otherwise specified. The biospecimens will be accessible for future research with an approved Sample Use Agreement. The VA Central Institutional Review Board (CIRB) will oversee the biorepository for this study. All samples will be destroyed by standard practice within 20 years of study completion. Sample destruction will be validated according to the Standard Operating Procedures of the VA Biorepository.

6. Conditions and Keywords

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

COVID-19

Keywords

2019 novel coronavirus disease, COVID-19 pandemic, COVID-19 virus infection, COVID-19 virus disease, Respiratory failure, Pneumonia, viral / therapy, Blood Component Transfusion, Severity of Illness Index, Survival Analysis, Treatment Outcome, Prospective Study, Humans, Adults, Male, Female, convalescent plasma, SARS CoV-2, COVID-19 convalescent plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

There are two study treatment arms: convalescent plasma versus saline. Participants will be randomized in 1:1 ratio to these two arms.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The participants, site investigators, clinical prescribers, site coordinators, and most other individuals involved in this study will be blinded to the treatment assignment. Furthermore, the blind will not routinely be broken in order to select post-study, pharmacologic treatment for SARS-CoV-2 infection administered by clinical healthcare providers.

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Convalescent Plasma

Arm Type

Experimental

Arm Description

The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.

Arm Title

Masked Saline Placebo

Arm Type

Placebo Comparator

Arm Description

The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.

Intervention Type

Drug

Intervention Name(s)

Convalescent Plasma

Other Intervention Name(s)

COVID-19 Convalescent Plasma (CCP)

Intervention Description

Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.

Intervention Type

Other

Intervention Name(s)

Masked Saline Placebo

Other Intervention Name(s)

Normal Saline (NS)

Intervention Description

0.9% saline solution will be used as the Masked Saline Placebo

Primary Outcome Measure Information:

Title

Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death

Description

Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.

Time Frame

Day 1 through Day 28

Secondary Outcome Measure Information:

Title

Time (in Days) to Recovery

Description

Time Frame

Day 1 through Day 28

Title

Time (in Days) to Death or Respiratory Failure

Description

Time Frame

Day 1 through Day 28

Title

Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm

Description

Time Frame

Day 1 through Day 28

Title

Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm

Description

Time to death or respiratory failure is defined as the first day on which the subject died from any cause, had respiratory failure (defined above), or who required HHHFNC at >= 15 Lpm.

Time Frame

Day 1 through Day 28

Title

Number of Participants With 28-day All-cause Mortality

Description

Death for Any Reason

Time Frame

Day 1 through Day 28

Title

Time to an Improvement of at Least One Category Using an Ordinal Scale

Description

Time Frame

Up through 28 days.

Title

Time to an Improvement of at Least Two Categories Using an Ordinal Scale

Description

Time Frame

Up through 28 days.

Title

Participant's Clinical Status by Ordinal Scale

Description

Time Frame

Days 2, 4, 7, 11, 14, 21, and 28

Title

Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28

Description

Time Frame

From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.

Title

Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28

Description

Time Frame

From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.

Title

Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First

Description

Time Frame

Up through 28 days.

Title

Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29

Description

Time Frame

From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29

Title

Duration of Hospitalization

Description

Number of Days Hospitalized During Initial Hospitalization

Time Frame

Day 1 through Day 28

Title

Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason)

Description

Number of participants for whom study product administration was discontinued or temporarily suspended for any reason

Time Frame

Day 1 through Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Veterans must meet all of the following criteria to be eligible to participate: Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection. Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures. Participant (or legally authorized representative) understands and agrees to comply with planned study procedures. Veteran 18 years of age at time of screening. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or antigen test, as documented by either of the following: (1)Reverse Transcription polymerase chain reaction (RT-PCR) or antigen positive (nasopharyngeal, oropharyngeal, saliva, lower respiratory) in sample collected 72 hours prior to screening; (2)RT-PCR or antigen positive in sample collected > 72 hours but 168 hours (i.e. 7 days) prior to screening, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.), AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 6.Requiring oxygen by nasal cannula or by face-mask as a new treatment (or if previously on home oxygen, at a liter flow at least 2 Lpm greater than home prescription), but not on humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm. 7.Can be randomized within 72 hours of hospital admission. 8.Agrees not to participate in another therapeutic clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29 without approval from the investigator(s). Taking part in other research studies, including those unrelated to SARS-CoV-2, without first discussing it with the investigators of this study may invalidate the results of this study, as well as that of the other study. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Respiratory failure requiring mechanical ventilation, non-invasive ventilation including continuous positive airway pressure (CPAP) (for an indication other than previously diagnosed sleep apnea and maintained on outpatient settings), or extra-corporeal membrane oxygenation or anticipated to require any of those treatments or to die within 24 hours. Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours. History of previous transfusion reaction. Previously documented serum immunoglobulin A (IgA) deficiency (<7 mg/dL) Documented to have received convalescent plasma in the last 60 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward N. Janoff, MD

Organizational Affiliation

Rocky Mountain Regional VA Medical Center, Aurora, CO

Official's Role

Study Chair

Facility Information:

Facility Name

Birmingham VA Medical Center, Birmingham, AL

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Phoenix VA Health Care System, Phoenix, AZ

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

Rocky Mountain Regional VA Medical Center, Aurora, CO

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

North Florida/South Georgia Veterans Health System, Gainesville, FL

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Orlando VA Medical Center, Orlando, FL

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

James A. Haley Veterans' Hospital, Tampa, FL

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Atlanta VA Medical and Rehab Center, Decatur, GA

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Edward Hines Jr. VA Hospital, Hines, IL

City

Hines

State/Province

Illinois

ZIP/Postal Code

60141-5000

Country

United States

Facility Name

VA Ann Arbor Healthcare System, Ann Arbor, MI

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

John D. Dingell VA Medical Center, Detroit, MI

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

VA Southern Nevada Healthcare System, North Las Vegas, NV

City

North Las Vegas

State/Province

Nevada

ZIP/Postal Code

89086

Country

United States

Facility Name

James J. Peters VA Medical Center, Bronx, NY

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

Facility Name

Durham VA Medical Center, Durham, NC

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Louis Stokes VA Medical Center, Cleveland, OH

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Oklahoma City VA Medical Center, Oklahoma City, OK

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

VA Portland Health Care System, Portland, OR

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Ralph H. Johnson VA Medical Center, Charleston, SC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401-5799

Country

United States

Facility Name

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Michael E. DeBakey VA Medical Center, Houston, TX

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

South Texas Health Care System, San Antonio, TX

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

VA Salt Lake City Health Care System, Salt Lake City, UT

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84148

Country

United States

Facility Name

Hunter Holmes McGuire VA Medical Center, Richmond, VA

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

William S. Middleton Memorial Veterans Hospital, Madison, WI

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

VA Caribbean Healthcare System, San Juan, PR

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35229691

Citation

Miller EK, Goldberg AM, Janoff EN, Brown ST, Curtis JL, Bonomo RA, Shih MC, Gleason TC. Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs. Clin Trials. 2022 Apr;19(2):137-145. doi: 10.1177/17407745211069703. Epub 2022 Mar 1.

Results Reference

derived

Learn more about this trial

VA CoronavirUs Research and Efficacy Studies-1

We'll reach out to this number within 24 hrs