NCT04864535

Brief Summary

Decentralized clinical study designed to collect cough sounds and self-reported symptoms alongside a COVID-19 realtime quantitative polymerase chain reaction (rt-qPCR) test. The aim of the data collection is to develop a safe and effective cough based digital screening tool for COVID-19.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

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

April 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 30, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

April 22, 2021

Last Update Submit

March 27, 2023

Conditions

Covid19

Keywords

COVID-19Cough

Outcome Measures

Primary Outcomes (2)

  • Collection of cough sound recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR.

    Cough sound recordings and symptoms from COVID-positive patients

    3 months

  • Development of an algorithm that uses a combination of cough sounds and self-reported symptoms that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.

    Cough sound algorithm that distinguishes with COVID-19 positive and negative cough sounds.

    3 months

Secondary Outcomes (1)

  • Development of an algorithm that uses cough sounds that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.

    3 months

Other Outcomes (1)

  • Development of an algorithm that uses a combination of cough sounds and patient-reported symptoms that is capable of predicting rt-qPCR Ct value for a participant.

    3 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 minimum of 100 participants who test positive for COVID-19 on rt-qPCR will be recruited. Based on average COVID-19 incidence rates in high incidence US geographies (\~8-12%), this study will enrol a cohort of up to 1500 participants on a rolling basis, to allow for sufficient cough recordings from COVID-19 positive participants to be collected for analysis. 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 able to provide at least 5 coughs (voluntary and/or spontaneous);
  • if enrolling online in Arm 1, the participant must be unvaccinated against COVID-19 (have not received one or more doses of a COVID-19 vaccine at any time before study enrolment)

You may not qualify if:

  • have 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-19Cough

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shrawan Patel, MBBS BSc

    Strategy Health LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 29, 2021

Study Start

May 12, 2021

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

March 30, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)