- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425044
AiM Covid Self Monitoring
June 9, 2020 updated by: Aarogyam UK
Efficacy of AiM Covid Self Monitoring in Detecting Infection of COVID-19
The objectives of this study are to test the level of accuracy of the prediction models that could be used as a 'digital test' to evaluate whether an individual is infected with COVID-19, based on their symptoms reported in the "AiM COVID-19" app
Study Overview
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India
- Mothers Touch Foundation
-
-
Rajasthan
-
Jaipur, Rajasthan, India
- NMP Medical Research Institite
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Anyone worried about heath status relating with infection of COVID-19
Description
Inclusion Criteria:
- Participants resident in India
- Voluntary completion of the self-test and evaluation.
Exclusion Criteria:
- People can not use mobile app
- Below 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AiM Covid
Self Monitoring of symptoms in AiM Covid App
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fever
Time Frame: 1 day
|
Self reported body temperature (Degrees Celsius)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shortness of Breath
Time Frame: 1 day
|
Self reported shortness of breath symptom (tick box)
|
1 day
|
Cough
Time Frame: 1 day
|
Self reported cough symptom (tick box)
|
1 day
|
Sore Throat
Time Frame: 1 day
|
Self reported soar throat symptom (tick box)
|
1 day
|
Headache
Time Frame: 1 day
|
Self reported headache symptom (tick box)
|
1 day
|
Muscle/ Joint Pain
Time Frame: 1 day
|
Self reported muscle/ joint pain symptom (tick box)
|
1 day
|
Diarrhoea
Time Frame: 1 day
|
Self reported diarrhoea symptom (tick box)
|
1 day
|
Vomiting/ Nausea
Time Frame: 1 day
|
Self reported vomiting/ nausea symptom (tick box)
|
1 day
|
Runny Nose
Time Frame: 1 day
|
Self reported runny nose symptom (tick box)
|
1 day
|
Loss of Smell/Taste
Time Frame: 1 day
|
Self reported loss of smell/ taste symptom (tick box)
|
1 day
|
Other symptoms
Time Frame: 1 day
|
Self reported other symptoms (tick box)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vishwes Kulkarni, University of Warwick
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2020
Primary Completion (Actual)
May 18, 2020
Study Completion (Actual)
May 28, 2020
Study Registration Dates
First Submitted
June 9, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Au015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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