NCT04989452

Brief Summary

Decentralized clinical study designed to collect further cough sounds, self-reported symptoms, and medical treatment questionnaires from participants enrolled on the COVID-Cough Study ("Study 1"). The aim of this further data collection study ("Study 2") is to:

  1. 1.develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease;
  2. 2.develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and
  3. 3.gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

July 30, 2021

Last Update Submit

March 27, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • Collection of cough sound audio recordings made using a smartphone, self-reported respiratory symptoms, COVID-19 rt-qPCR result and medical treatment information on 3 occasions (day 1, day 10, day 25).

    6 months

  • Sensitivity and specificity of using cough sound analysis on longitudinal cough sounds to detect COVID-19 as compared to rt-qPCR test.

    10 months

  • Sensitivity and specificity of longitudinal cough sounds to detect whether study participants have required recent medical care for COVID-19 related illness.

    10 months

Secondary Outcomes (1)

  • Confusion matrix outputs of cough sound algorithm prediction of COVID-19 severity compared against COVID-19 severity measured by a combination of medical history survey and rt-qPCR test.

    10 months

Interventions

Recordings of cough sounds from adultsDIAGNOSTIC_TEST

Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A list of COVID-19 positive and negative participants, and their consent to inform them of this study (and possible future studies) will be created through the administration of Study 1. Using this list of potential study participants we seek to enroll as many participants identified through Study 1 as possible (up to 1,500 individuals). Participants will be aged 21 years and older and will not be excluded based on gender, demographic group, or geographic location within the US.

You may qualify if:

  • be aged 21 years and older;
  • be a resident of the USA;
  • have a personal (i.e., not shared) iPhone 6s or newer running iOS 14 or later;
  • be able to read and understand English;
  • be able to provide informed consent;
  • be willing to follow study procedures;
  • be able to provide at least 5 coughs (voluntary and/or spontaneous);
  • have enrolled in the COVID-Cough Study and successfully returned an at-home rt-qPCR test to the study partner laboratory

You may not qualify if:

  • Participant has one or more medical contraindication to voluntary cough, including the following:
  • Severe respiratory distress;
  • History of pneumothorax;
  • Eye, chest, or abdominal surgery within 3 months of enrolling for the study; or
  • Hemoptysis (coughing up of blood) within 1 month of enrolling for the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strategy Health LLC

New York, New York, 10024, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shrawan Patel, MBBS,BSc

    Strategy Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 4, 2021

Study Start

August 10, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.

Locations

US(1)