COVID-19COVIDansNCT05081362
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
A study testing Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity in people with COVID-19, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity. 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?
- Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2021to 9 Nov 2022
- 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
- age over 18
- spontaneous sinus rhythm
- signed informed consent
Who cannot join
- no spontaneous sinus rhythm
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.
- Conditions
- COVID-19
- Being tested
- Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activityOther
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position
| Study group | Role | What they receive |
|---|---|---|
| COVID-severe | Other | patient recovered from severe COVID desease Receives: Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity |
| COVID-moderate | Other | patient recovered from moderate COVID desease Receives: Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity |
| COVID-mild | Other | patient recovered from mild COVID desease Receives: Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pressure measured in mmHg
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
Measured: 6 months
Heart rate measured in bpm
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
Measured: 6 months
Respiratory frequency
Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start18 Oct 2021
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
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 IRCCS Policlinico S. DonatoThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081362
- Sponsor's protocol ID
- COVIDans
- Acronym
- COVIDans
- Status last verified
- Jan 2023
- First submitted
- 7 Oct 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
- ClinicalTrials.gov ID
- NCT05081362
- Acronym / sponsor ID
- COVIDans / COVIDans
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 18 Oct 2021 (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 goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-severe | Other | Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activitypatient recovered from severe COVID desease |
| COVID-moderate | Other | Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activitypatient recovered from moderate COVID desease |
| COVID-mild | Other | Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activitypatient recovered from mild COVID desease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18
- spontaneous sinus rhythm
- signed informed consent
Key exclusion criteria (2 listed)
- no spontaneous sinus rhythm
- pregnancy
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 |
|---|---|---|
| Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activityNon invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position | Other | COVID-mild, COVID-moderate, COVID-severe |
Primary outcome
Arterial pressure measured in mmHg
Time frame: 6 months
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
Heart rate measured in bpm
Time frame: 6 months
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
Respiratory frequency
Time frame: 6 months
Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity in people with COVID-19, run by IRCCS Policlinico S. Donato 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 3 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 25 Jan 2023. 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 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?
Arterial pressure measured in mmHg (time frame: 6 months). The study lists 3 primary outcomes in all. 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 25 Jan 2023.