Covid19NCT04425044
AiM Covid Self Monitoring
An observational study of Covid19, run by Aarogyam UK at 2 sites in India.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Other
- How many people
- 1,000 participants
- Where
- 2 sitesIndia
- Study dates
- 12 Apr 2020to 28 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anyone worried about heath status relating with infection of COVID-19
Who may be able to join
- Participants resident in India
- Voluntary completion of the self-test and evaluation.
Who cannot join
- People can not use mobile app
- Below 18 years old
Trial locations and contacts
2 sites in 1 country.
India2 sites
NMP Medical Research Institite
Jaipur, Rajasthan
Mothers Touch Foundation
Mumbai, Maharashtra
About this study
Official title: 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
- Conditions
- Covid19
- Being tested
- Other
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| AiM Covid | Self Monitoring of symptoms in AiM Covid App Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Self reported body temperature (Degrees Celsius)
Measured: 1 day
Secondary outcomes (10)
Shortness of Breath
Self reported shortness of breath symptom (tick box)
Measured: 1 day
Cough
Self reported cough symptom (tick box)
Measured: 1 day
Sore Throat
Self reported soar throat symptom (tick box)
Measured: 1 day
Headache
Self reported headache symptom (tick box)
Measured: 1 day
Muscle/ Joint Pain
Self reported muscle/ joint pain symptom (tick box)
Measured: 1 day
Diarrhoea
Self reported diarrhoea symptom (tick box)
Measured: 1 day
Vomiting/ Nausea
Self reported vomiting/ nausea symptom (tick box)
Measured: 1 day
Runny Nose
Self reported runny nose symptom (tick box)
Measured: 1 day
Loss of Smell/Taste
Self reported loss of smell/ taste symptom (tick box)
Measured: 1 day
Other symptoms
Self reported other symptoms (tick box)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 Apr 2020
- Primary completion18 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, NMP Medical Research Institute, Mothers Touch Foundation
- Responsible party
- Sponsor
- Investigators
- Vishwes Kulkarni, Principal investigator, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425044
- Sponsor's protocol ID
- Au015
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of AiM Covid Self Monitoring in Detecting Infection of COVID-19
- ClinicalTrials.gov ID
- NCT04425044
- Acronym / sponsor ID
- Au015
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- University of Warwick, NMP Medical Research Institute, Mothers Touch Foundation
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AiM Covid | – | Other: OtherSelf Monitoring of symptoms in AiM Covid App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone worried about heath status relating with infection of COVID-19
Key inclusion criteria (2 listed)
- Participants resident in India
- Voluntary completion of the self-test and evaluation.
Key exclusion criteria (2 listed)
- People can not use mobile app
- Below 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherNo Intervention | Other | AiM Covid |
Primary outcome
Fever
Time frame: 1 day
Self reported body temperature (Degrees Celsius)
10 secondary outcomes
Shortness of Breath
Time frame: 1 day
Cough
Time frame: 1 day
Sore Throat
Time frame: 1 day
Headache
Time frame: 1 day
Muscle/ Joint Pain
Time frame: 1 day
Diarrhoea
Time frame: 1 day
Vomiting/ Nausea
Time frame: 1 day
Runny Nose
Time frame: 1 day
Loss of Smell/Taste
Time frame: 1 day
Other symptoms
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishwes Kulkarni principal investigator
University of Warwick
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Aarogyam UK at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.