COVID-19Mon-CovidNCT04361916
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
A study testing home care monitoring in people with COVID-19, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care. Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- home care monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2020to 30 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.
- Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care.
Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.
Read the detailed description
The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.
Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count.
Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2< 90% OR SpO2> 90% with desaturation index of at least 5% at Quick Walk Test)
- Conditions
- COVID-19
- Being tested
- home care monitoring
- Keywords
- COVID-19, oximetry, active monitoring, home care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home care monitoringOther
home care active monitoring of patients with suspected of confirmed COVID-19
| Study group | Role | What they receive |
|---|---|---|
| home care with active monitoring | Experimental | home care with active monitoring conducted by health workers with daily visit to patients. Receives: Other: home care monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 at hospital entry
Peripheral blood saturation measured on arrival to the hospital
Measured: 24 hours
Secondary outcomes (3)
in-hospital mortality
death during hospitalization
Measured: 30 days
need of intubation
need of intubation
Measured: 30 days
Percentage of hospitalized patients among those with recommendation of hospitalization
To evaluate the feasibility of active monitoring, we will consider the percentage of patients who will be actually hospitalized within 24 hours after the recommendation of hospitalization
Measured: 30 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 start21 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: interrupted early due to the drastic reduction in the number of cases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, open label trial on active home monitoring strategy
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Bertolini, MD, Principal investigator, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361916
- Sponsor's protocol ID
- Mon-Covid
- Acronym
- Mon-Covid
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available from the study sponsor upon legitimate request
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
- ClinicalTrials.gov ID
- NCT04361916
- Acronym / sponsor ID
- Mon-Covid / Mon-Covid
- Conditions
- COVID-19
- Keywords
- COVID-19, oximetry, active monitoring, home care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interrupted early due to the drastic reduction in the number of cases
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- 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.
Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care.
Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.
Detailed description
The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.
Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count.
Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2< 90% OR SpO2> 90% with desaturation index of at least 5% at Quick Walk Test)
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, open label trial on active home monitoring strategy
| Arm | Type | Receives |
|---|---|---|
| home care with active monitoring | Experimental | Other: home care monitoringhome care with active monitoring conducted by health workers with daily visit to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.
- Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| home care monitoringhome care active monitoring of patients with suspected of confirmed COVID-19 | Other | home care with active monitoring |
Primary outcome
SpO2 at hospital entry
Time frame: 24 hours
Peripheral blood saturation measured on arrival to the hospital
3 secondary outcomes
in-hospital mortality
Time frame: 30 days
need of intubation
Time frame: 30 days
Percentage of hospitalized patients among those with recommendation of hospitalization
Time frame: 30 days
Results and safety
The study was stopped early (reason given: interrupted early due to the drastic reduction in the number of cases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Yes. data will be available from the study sponsor upon legitimate request
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Guido Bertolini, MD principal investigator
Mario Negri Institute for Pharmacological Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home care monitoring in people with COVID-19, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 0 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: stopped early, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: interrupted early due to the drastic reduction in the number of cases). 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?
SpO2 at hospital entry (time frame: 24 hours). 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 14 Sep 2020.