---
title: VA CoronavirUs Research and Efficacy Studies-1
nct_id: NCT04539275
overall_status: TERMINATED
phase: PHASE3
sponsor: VA Office of Research and Development
study_type: INTERVENTIONAL
primary_condition: COVID-19
countries: United States, Puerto Rico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04539275.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04539275"
ct_last_update_post_date: 2022-09-23
last_seen_at: "2026-05-12T06:28:37.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# VA CoronavirUs Research and Efficacy Studies-1

**Official Title:** VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1)

**NCT ID:** [NCT04539275](https://clinicaltrials.gov/study/NCT04539275)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** DMC recommended early termination of enrollment
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** VA Office of Research and Development
- **Conditions:** COVID-19
- **Start Date:** 2020-11-16
- **Completion Date:** 2021-09-30
- **CT.gov Last Update:** 2022-09-23

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

1. Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection.
2. Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Participant (or legally authorized representative) understands and agrees to comply with planned study procedures.
4. Veteran 18 years of age at time of screening.
5. 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:

1. 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.
2. Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours.
3. History of previous transfusion reaction.
4. Previously documented serum immunoglobulin A (IgA) deficiency (\<7 mg/dL)
5. Documented to have received convalescent plasma in the last 60 days.
```

## Arms

- **Convalescent Plasma** (EXPERIMENTAL) — 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.
- **Masked Saline Placebo** (PLACEBO_COMPARATOR) — 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.

## Interventions

- **Convalescent Plasma** (DRUG) — Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
- **Masked Saline Placebo** (OTHER) — 0.9% saline solution will be used as the Masked Saline Placebo

## Primary Outcomes

- **Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death** _(time frame: Day 1 through Day 28)_ — Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.

## Secondary Outcomes

- **Time (in Days) to Recovery** _(time frame: Day 1 through Day 28)_
- **Time (in Days) to Death or Respiratory Failure** _(time frame: Day 1 through Day 28)_
- **Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm** _(time frame: Day 1 through Day 28)_
- **Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm** _(time frame: Day 1 through Day 28)_
- **Number of Participants With 28-day All-cause Mortality** _(time frame: Day 1 through Day 28)_
- **Time to an Improvement of at Least One Category Using an Ordinal Scale** _(time frame: Up through 28 days.)_
- **Time to an Improvement of at Least Two Categories Using an Ordinal Scale** _(time frame: Up through 28 days.)_
- **Participant's Clinical Status by Ordinal Scale** _(time frame: Days 2, 4, 7, 11, 14, 21, and 28)_
- **Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28** _(time frame: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.)_
- **Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28** _(time frame: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.)_
- **Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First** _(time frame: Up through 28 days.)_
- **Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29** _(time frame: From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29)_
- **Duration of Hospitalization** _(time frame: Day 1 through Day 28)_
- **Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason)** _(time frame: Day 1 through Day 3)_

## Locations (24)

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

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `locations.atlanta va medical and rehab center, decatur, ga|decatur|georgia|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.birmingham va medical center, birmingham, al|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.phoenix va health care system, phoenix, az|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.rocky mountain regional va medical center, aurora, co|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.north florida/south georgia veterans health system, gainesville, fl|gainesville|florida|united states` — added _(2026-05-12)_
- `locations.orlando va medical center, orlando, fl|orlando|florida|united states` — added _(2026-05-12)_
- `locations.james a. haley veterans' hospital, tampa, fl|tampa|florida|united states` — added _(2026-05-12)_
- `locations.edward hines jr. va hospital, hines, il|hines|illinois|united states` — added _(2026-05-12)_
- `locations.va ann arbor healthcare system, ann arbor, mi|ann arbor|michigan|united states` — added _(2026-05-12)_
- `locations.john d. dingell va medical center, detroit, mi|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.va southern nevada healthcare system, north las vegas, nv|north las vegas|nevada|united states` — added _(2026-05-12)_
- `locations.james j. peters va medical center, bronx, ny|the bronx|new york|united states` — added _(2026-05-12)_
- `locations.durham va medical center, durham, nc|durham|north carolina|united states` — added _(2026-05-12)_
- `locations.louis stokes va medical center, cleveland, oh|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.oklahoma city va medical center, oklahoma city, ok|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.va portland health care system, portland, or|portland|oregon|united states` — added _(2026-05-12)_
- `locations.ralph h. johnson va medical center, charleston, sc|charleston|south carolina|united states` — added _(2026-05-12)_
- `locations.va north texas health care system dallas va medical center, dallas, tx|dallas|texas|united states` — added _(2026-05-12)_
- `locations.michael e. debakey va medical center, houston, tx|houston|texas|united states` — added _(2026-05-12)_
- `locations.south texas health care system, san antonio, tx|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.va salt lake city health care system, salt lake city, ut|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.hunter holmes mcguire va medical center, richmond, va|richmond|virginia|united states` — added _(2026-05-12)_
- `locations.william s. middleton memorial veterans hospital, madison, wi|madison|wisconsin|united states` — added _(2026-05-12)_
- `locations.va caribbean healthcare system, san juan, pr|san juan||puerto rico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04539275.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04539275*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*