# BRAIN-2 Administrative Supplement with ORCHID-BUD

> **NIH NIH R01** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2020 · $424,619

## Abstract

PROJECT SUMMARY
Medical teams globally are consumed in caring for patients with respiratory failure and acute comorbidities
caused by Coronavirus Disease 2019 (COVID-19). To understand the full impact of this pandemic on the lives
of survivors and the magnitude of this emerging public health crisis, we must study the brain. We helped define
the plague of disabling features suffered by millions of intensive care unit (ICU) survivors called Post-Intensive
Care Syndrome (PICS), characterized by an acquired Alzheimer's disease and related dementia (ADRD), post-
traumatic stress disorder (PTSD), and depression. Approximately 10% to 15% of COVID-19 patients develop
hypoxemia requiring hospitalization, which can lead to acute respiratory distress syndrome and the need for
life support, including mechanical ventilation. Up to 26% of hospitalized patients with COVID-19 require ICU
admission. We hypothesize that COVID-19 survivors who are hospitalized will have a high burden of PICS-
related acquired-ADRD, PTSD, and depression. To test this hypothesis, we propose this NIH Administrative
Supplement to the BRAIN-ICU-2 Study (R01AG058639). This Administrative Supplement will allow us to use
the BRAIN-ICU-2 long-term follow-up infrastructure to collect 6-month cognition, PTSD, and depression data
for a NHLBI-sponsored randomized trial (ORCHID) that is evaluating hydroxychloroquine versus placebo on
15-day death, mechanical ventilation, or oxygen supplementation. We will ascertain these 6-month outcomes
using a comprehensive phone battery that incorporates robust neuropsychological tests for memory, attention,
language, reasoning, and executive function, and diagnostic evaluations for PTSD and depression. Our
Administrative Supplement is titled “Outcomes Related to COVID-19 treated with Hydroxychloroquine among
In-patients with symptomatic Disease - Brain Outcomes and Psychological Distress (ORCHID-BUD)” and will
conduct 6-month follow-up assessments in 270 adults who are hospitalized with COVID-19 infection and
survive. ORCHID-BUD has the following specific aims: (1) To determine the epidemiology (i.e., prevalence) of
cognitive impairment (i.e., acquired-dementia) at 6 months and if hydroxychloroquine administration is
associated with improvement in these same outcomes; (2) To determine the epidemiology of PTSD and
depression at 6-months, and if hydroxychloroquine administration is associated with improvement in these
same outcomes, and (3) To identify modifiable risk factors (e.g., sedatives, isolation, intravenous fluids,
pressor, ACE-inhibitor or ARB use, etc.) associated with worse long-term cognitive impairment, PTSD, and
depression at 6 months. To our knowledge, this investigation will be the first ever to conduct robust
neuropsychological assessments for SARS, MERS or COVID-19 survivors, and the first among COVID-19 to
conduct diagnostic PTSD and depression assessments. This Administrative Supplement will leverage BRAIN-
ICU-2 and ORCHID's resources to ...

## Key facts

- **NIH application ID:** 10140087
- **Project number:** 3R01AG058639-02S1
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** E Wesley ELY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $424,619
- **Award type:** 3
- **Project period:** 2019-04-15 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10140087

## Citation

> US National Institutes of Health, RePORTER application 10140087, BRAIN-2 Administrative Supplement with ORCHID-BUD (3R01AG058639-02S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10140087. Licensed CC0.

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