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Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2

Award Number: U01DC019579
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/21/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2 - Abstract: Self-report of sudden loss of smell or taste substantially increases the odds of being infected with SARS-CoV-2 (10 – 37-fold). However, self-report of smell function is an unreliable predictor of smell loss. Based on our experience developing smell tests with personalized algorithms for asymptomatic detection of Alzheimer's disease, we created a self-administered easy to use “at home” 5-minute objective smell test to uncover alterations in smell function unbeknownst to many individuals, and confer increased risk of infection by SARS- CoV-2. Our new smell test consists of a physical smell card containing peel and sniff odor labels and a web- based application. The disposable smell card reduces the risk that the smell test serves as a vector of transmission to other patients, research staff, and to health care workers. Each participant accesses the web- based app on their own smartphone, tablet, or computer. In our pilot studies, we validated each participant's COVID status by extracting results of clinical SARS-CoV-2 RT PCR assays from electronic health records. The smell test provides better area under the curve for SARS-CoV-2 infection (0.83 – 0.85) in both US and Argentinian symptomatic patients (ages 19 - 87) than symptom tracking alone (0.66). We are expanding the smell test from one smell card with three odors to 6 smell cards, each with 3 different odors (18 odors total). Having six different versions of the smell card will afford longitudinal screening several times per week and provide data to construct personalized thresholds for changes in olfactory function - each person serving as their own control and monitoring for diminishment of their expected performance based on their personal trajectory rather than being based on population norms. Here we propose to develop a native app to conduct longitudinal COVID Smell Test (Aim 1), collect data on asymptomatic health care workers, symptomatic patients, and undergraduates (Aim 2) and develop algorithms for the longitudinal smell test for personalized thresholds, differentiate smell loss from COVID relative to influenza, and assess risk of developing pulmonary disease in COVID infected patients (Aim 3). The Longitudinal COVID Smell Test is accessible, affordable, and readily scalable. Effective screening with the COVID smell test will better inform students and employees if they should not report to school or work, and seek an evaluation by a healthcare professional and molecular testing at an early, often asymptomatic, stage of the disease.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	000	3	4/30/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2021	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	001	2	6/7/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	000	3	10/24/2022	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2022	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	001	3	5/5/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $436,605 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	002	3	6/30/2022	EXTENSION WITH OR WITHOUT FUNDS	$436,605
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	001	2	6/2/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	003	2	8/5/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	000	2	11/26/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $436,605

Issue Date FY: 2021 ( Subtotal = $877,287 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	002	2	7/29/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$877,287
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Trans-NIH Research Support	003	2	8/13/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2021	ADK GROUP, LLC	11 BEACON ST STE 1200	BOSTON	MA	02108	SUFFOLK	USA	Trans-NIH Research Support	001	1	7/28/2021	NEW	-$877,288
2021	2021	ADK GROUP, LLC	11 BEACON ST STE 1200	BOSTON	MA	02108	SUFFOLK	USA	Trans-NIH Research Support	000	1	12/21/2020	NEW	$877,288
														Subtotal = $877,287

Grand Total All Awards = $1,313,892

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Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2

Award Number: U01DC019579

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/21/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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