COVID-19DISTANSE COVIDNCT04359264
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial
A study testing Cash transfer in people with COVID-19, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Cash transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Apr 2020to 30 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- trouble "making ends meet at the end of the month" due to COVID-19 related disruptions
Who cannot join
- confirmed positive for COVID-19 based on laboratory testing
- current symptoms consistent with COVID-19
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Municipality of Assiginack Family Health Team
Assiginack, Ontario, P0P 1N0
St Michael's Hospital Academic Family Health Team
Toronto, Ontario, M5B 1W8
About this study
Official title: Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)
This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.
- Conditions
- COVID-19
- Being tested
- Cash transfer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash transferOther
Cash transfer of $1000
| Study group | Role | What they receive |
|---|---|---|
| Cash transfer | Experimental | Not described Receives: Other: Cash transfer |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms consisent with COVID-19
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
Measured: 14 days
Secondary outcomes (4)
Number of close contacts
Measured: Sum of contacts on days 5, 10 and 14
Number of participants with positive test for COVID-19
Measured: 14 days
Self-reported health based on the single question: "In general, would you say your health is.."
Measured: 14 days
Ability to make ends meet based on the single question: "At the end of the month, are you able to make ends meet?"
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020
- Primary completion29 May 2020
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359264
- Sponsor's protocol ID
- 20-081
- Acronym
- DISTANSE COVID
- Status last verified
- Jul 2020
- First submitted
- 16 Apr 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Persaud N, Thorpe KE, Bedard M, Hwang SW, Pinto A, Juni P, da Costa BR; DISTANSE COVID-19 (Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a randomized controlled trial) study team. Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial. Fam Med Community Health. 2021 Dec;9(4):e001452. doi: 10.1136/fmch-2021-001452.
PubMed 34924360
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)
- ClinicalTrials.gov ID
- NCT04359264
- Acronym / sponsor ID
- DISTANSE COVID / 20-081
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Apr 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.
This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cash transfer | Experimental | Other: Cash transfer |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- trouble "making ends meet at the end of the month" due to COVID-19 related disruptions
Key exclusion criteria (2 listed)
- confirmed positive for COVID-19 based on laboratory testing
- current symptoms consistent with COVID-19
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 |
|---|---|---|
| Cash transferCash transfer of $1000 | Other | Cash transfer |
Primary outcome
Symptoms consisent with COVID-19
Time frame: 14 days
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
4 secondary outcomes
Number of close contacts
Time frame: Sum of contacts on days 5, 10 and 14
Number of participants with positive test for COVID-19
Time frame: 14 days
Self-reported health based on the single question: "In general, would you say your health is.."
Time frame: 14 days
Ability to make ends meet based on the single question: "At the end of the month, are you able to make ends meet?"
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 34924360Persaud N, Thorpe KE, Bedard M, Hwang SW, Pinto A, Juni P, da Costa BR; DISTANSE COVID-19 (Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a randomized controlled trial) study team. Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial. Fam Med Community Health. 2021 Dec;9(4):e001452. doi: 10.1136/fmch-2021-001452.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash transfer in people with COVID-19, run by Unity Health Toronto at 2 sites in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Jul 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 Canada. 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?
Results are not available in the source record.
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?
Symptoms consisent with COVID-19 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359264, which also lists 1 linked publication.
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 7 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.