# 2/2 Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis

> **NIH NIH U24** · FRED HUTCHINSON CANCER CENTER · 2022 · $236,301

## Abstract

PROJECT SUMMARY/ABSTRACT
Compelling evidence has emerged to implicate cytomegalovirus (CMV) reactivation as a causal contributor to
morbidity and mortality in sepsis-associated respiratory failure. A phase 3 randomized placebo-controlled trial
called “GRAIL Phase 3” is planned to determine whether the use of an antiviral drug called ganciclovir can
safely and effectively prevent reactivation of CMV and improve clinical outcomes in adults with sepsis-
associated acute respiratory failure.
As a companion to the UG3 GRAIL Phase 3 Clinical Coordinating Center (CCC) application, this U24
application proposes to establish and operate a U24 GRAIL Phase 3 Data Coordinating Center (DCC) to
provide statistical and data management support for the proposed GRAIL Phase 3 trial. The DCC application
has four aims:
• Aim 1. Overall trial administration and coordination. The DCC will assist the CCC with overall trial
 operations, interactions and functions, including communication and coordination among the CCC, trial
 sites, and the National Heart, Lung, and Blood Institute (NHLBI).
• Aim 2. Protocol development, data management, and statistical Support. The DCC will collaborate in
 protocol development for GRAIL Phase 3. It will provide statistical leadership in trial design, choice of
 endpoint, power/sample size calculation, interim safety monitoring plan, and statistical analysis plan. The
 DCC will also use state-of-the-art electronic tools for flexible and reliable data collection and management.
• Aim 3. Quality assurance, Data and Safety Monitoring Board (DSMB) service, and document
 management. The DCC will assist with reviewing and establishing the required NHLBI processes for
 quality assurance. Working with the GRAIL Phase 3 DSMB, the DCC will assist with developing the DSMB
 Charter, and preparing open and closed DSMB reports. The DCC will establish a procedure for
 documenting and handling protocol deviations/violations during the GRAIL Phase 3 trial.
• Aim 4. Close-out activities and post GRAIL Phase 3 data management. The DCC will assist with the
 CCC for trial close-out activities. It will assist with preparing, reviewing, and submitting GRAIL Phase 3
 manuscripts and presentations for timely dissemination of trial results. The DCC will also prepare final
 annotated datasets for resource sharing.

## Key facts

- **NIH application ID:** 10652658
- **Project number:** 5U24HL147012-04
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Wendy M Leisenring
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $236,301
- **Award type:** 5
- **Project period:** 2020-09-16 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10652658

## Citation

> US National Institutes of Health, RePORTER application 10652658, 2/2 Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis (5U24HL147012-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10652658. Licensed CC0.

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