COVID-19NCT04728919
Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Tampere University Hospital at 1 site in Finland.
Trial summary
A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- How many people
- 82 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jan 2021to 15 Jan 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptoms of COVID-19 infection
Who may be able to join
- capable of breathing through nose, no need of supplemental oxygen, symptom onset within 10 days, positive SARS-CoV-2 test in Fimlab and capable of performing all required tests
Who cannot join
- need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication
Trial locations and contacts
1 site in 1 country.
About this study
A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function.
Read the detailed description
Materials and methods: Prospective cohort of 40 COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive patients from Tampere university hospital region are recruited to the study. Forty COVID-19 negative patients with similar symptoms act as a control group.
All subjects are screened for other respiratory viruses with reverse transcriptase polymerase chain reaction (RT-PCR)-multiplex tests. Viral loads of SARS-CoV-2 from anterior nasal cavity, nasopharynx, throat and saliva are evaluated by RT-PCR cycle treshold (Ct) value and antigen testing (RLU value).
During the first visit NEWS (National Early Warning Score), recorded pulmonary auscultation (Thinklabs One, Thinklabs Medical LLC), impulse oscillometry (Tremoflo, THORASYS Thoracic Medical Systems Inc), FeNO (fractional exhaled nitric oxide) and FnNO (fractional nasal nitric oxide) (NIOX VERO®,Circassia) are conducted. All aforementioned and a spirometry are measured again after 2 months.
Aims: To evaluate the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, viral load and lung function. To compare the capability of RT-PCR in detecting SARS-CoV-2 RNA from saliva, anterior nasal swab samples and oropharyngeal swap samples vs. the golden standard of nasopharyngeal swab samples. To compare the results of RT-PCR and antigen test in detecting SARS-CoV-2 from nasal and pharyngeal sample sites.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive cases | Subjects with acute respiratory infection and positive COVID-19 test, who are well enough to be treated at home. | |
| COVID-19 negative controls | Subjects with acute respiratory infection and negative COVID-19 test, who are well enough to be treated at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load of SARS-CoV-2 from different sample sites
RT-PCR (Ct value) and antigen testing (RLU value)
Measured: 0 months
Upper respiratory tract viruses
RT-PCR-multiplex tests, from nasopharyngeal sample site
Measured: 0 months
FeNO
Fractional exhaled nitric oxide in ppb obtained NIOX VERO
Measured: Baseline
FnNO
Nasal nitric oxide in ppb obtained NIOX VERO
Measured: Baseline
FeNO
Fractional exhaled nitric oxide in ppb obtained NIOX VERO
Measured: 2 months
Change in FeNO
FeNO at 2 months - FeNO at baseline
Measured: BAseline and at 2 months
FnNO
Nasal nitric oxide in ppb obtained NIOX VERO
Measured: 2 months
CHange in FnNO
FnNO at 2 moths - FnNO at baseline
Measured: Baseline and at 2 months
Airway resistance at 20Hz, R20
Airway resistance at 20Hz obtained from Impulse oscillometry
Measured: Baseline
Airway resistance at 5Hz, R5
Airway resistance at 5Hz obtained from Impulse oscillometry
Measured: Baseline
Airway resistance at 20 Hz, R20
Airway resistance at 20 Hz obtained from Impulse oscillometry
Measured: 2 months
Change in R20
R20 at 2 months - R20 at baseline
Measured: Baseline and at 2 months
Airway resistance at 5Hz, R5
Airway resistance at 5Hz obtained from Impulse oscillometry
Measured: 2 months
Change in R5
R5 at 2 months - R5 at baseline
Measured: Baseline and at 2 months
Reactance at 5Hz (X5)
Airway reactance at 5 Hz obtained from Impulse oscillometry
Measured: Baseline
Reactance at 5Hz (X5)
Airway reactance at 5 Hz obtained from Impulse oscillometry
Measured: 2 months
Change in X5
X5 at 2 months - X5 at baseline
Measured: Baseline and at 2 months
Resonant frequency (Fres)
Resonant frequency (Fres) obtained from Impulse oscillometry
Measured: Baseline
Resonant frequency (Fres)
Resonant frequency (Fres) obtained from Impulse oscillometry
Measured: 2 months
Change in Fres
Fres at 2 months - Fres at baseline
Measured: Baseline and at 2 months
Reactance area (AХ)
Reactance area (AХ) obtained from Impulse oscillometry
Measured: Baseline
Reactance area (AХ)
Reactance area (AХ) obtained from Impulse oscillometry
Measured: 2 months
Change in AX
AX at 2 months - AX at baseline
Measured: Baseline and at 2 months
Secondary outcomes (5)
FEV1
Forced expiratory volume in 1 second
Measured: 2 months
FVC
Forced vital capacity
Measured: 2 months
VC
Vital capacity
Measured: 2 months
FEV1/FVC
Forced expiratory volume in 1 second divided by forced vital capacity
Measured: 2 months
FEV1/VC
Forced expiratory volume in 1 second divided by vital capacity
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start15 Jan 2021
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
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 Tampere University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauri Lehtimäki, Tampere University Hospital
- Investigators
- Lauri Lehtimäki, Professor, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728919
- Sponsor's protocol ID
- R200090
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04728919
- Acronym / sponsor ID
- R200090
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 28 Jan 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.
A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function.
Detailed description
Materials and methods: Prospective cohort of 40 COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive patients from Tampere university hospital region are recruited to the study. Forty COVID-19 negative patients with similar symptoms act as a control group.
All subjects are screened for other respiratory viruses with reverse transcriptase polymerase chain reaction (RT-PCR)-multiplex tests. Viral loads of SARS-CoV-2 from anterior nasal cavity, nasopharynx, throat and saliva are evaluated by RT-PCR cycle treshold (Ct) value and antigen testing (RLU value).
During the first visit NEWS (National Early Warning Score), recorded pulmonary auscultation (Thinklabs One, Thinklabs Medical LLC), impulse oscillometry (Tremoflo, THORASYS Thoracic Medical Systems Inc), FeNO (fractional exhaled nitric oxide) and FnNO (fractional nasal nitric oxide) (NIOX VERO®,Circassia) are conducted. All aforementioned and a spirometry are measured again after 2 months.
Aims: To evaluate the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, viral load and lung function. To compare the capability of RT-PCR in detecting SARS-CoV-2 RNA from saliva, anterior nasal swab samples and oropharyngeal swap samples vs. the golden standard of nasopharyngeal swab samples. To compare the results of RT-PCR and antigen test in detecting SARS-CoV-2 from nasal and pharyngeal sample sites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive cases | – | –Subjects with acute respiratory infection and positive COVID-19 test, who are well enough to be treated at home. |
| COVID-19 negative controls | – | –Subjects with acute respiratory infection and negative COVID-19 test, who are well enough to be treated at home. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms of COVID-19 infection
Key inclusion criteria (1 listed)
- capable of breathing through nose, no need of supplemental oxygen, symptom onset within 10 days, positive SARS-CoV-2 test in Fimlab and capable of performing all required tests
Key exclusion criteria (1 listed)
- need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral load of SARS-CoV-2 from different sample sites
Time frame: 0 months
RT-PCR (Ct value) and antigen testing (RLU value)
Upper respiratory tract viruses
Time frame: 0 months
RT-PCR-multiplex tests, from nasopharyngeal sample site
FeNO
Time frame: Baseline
Fractional exhaled nitric oxide in ppb obtained NIOX VERO
FnNO
Time frame: Baseline
Nasal nitric oxide in ppb obtained NIOX VERO
FeNO
Time frame: 2 months
Fractional exhaled nitric oxide in ppb obtained NIOX VERO
Change in FeNO
Time frame: BAseline and at 2 months
FeNO at 2 months - FeNO at baseline
FnNO
Time frame: 2 months
Nasal nitric oxide in ppb obtained NIOX VERO
CHange in FnNO
Time frame: Baseline and at 2 months
FnNO at 2 moths - FnNO at baseline
Airway resistance at 20Hz, R20
Time frame: Baseline
Airway resistance at 20Hz obtained from Impulse oscillometry
Airway resistance at 5Hz, R5
Time frame: Baseline
Airway resistance at 5Hz obtained from Impulse oscillometry
Airway resistance at 20 Hz, R20
Time frame: 2 months
Airway resistance at 20 Hz obtained from Impulse oscillometry
Change in R20
Time frame: Baseline and at 2 months
R20 at 2 months - R20 at baseline
Airway resistance at 5Hz, R5
Time frame: 2 months
Airway resistance at 5Hz obtained from Impulse oscillometry
Change in R5
Time frame: Baseline and at 2 months
R5 at 2 months - R5 at baseline
Reactance at 5Hz (X5)
Time frame: Baseline
Airway reactance at 5 Hz obtained from Impulse oscillometry
Reactance at 5Hz (X5)
Time frame: 2 months
Airway reactance at 5 Hz obtained from Impulse oscillometry
Change in X5
Time frame: Baseline and at 2 months
X5 at 2 months - X5 at baseline
Resonant frequency (Fres)
Time frame: Baseline
Resonant frequency (Fres) obtained from Impulse oscillometry
Resonant frequency (Fres)
Time frame: 2 months
Resonant frequency (Fres) obtained from Impulse oscillometry
Change in Fres
Time frame: Baseline and at 2 months
Fres at 2 months - Fres at baseline
Reactance area (AХ)
Time frame: Baseline
Reactance area (AХ) obtained from Impulse oscillometry
Reactance area (AХ)
Time frame: 2 months
Reactance area (AХ) obtained from Impulse oscillometry
Change in AX
Time frame: Baseline and at 2 months
AX at 2 months - AX at baseline
5 secondary outcomes
FEV1
Time frame: 2 months
FVC
Time frame: 2 months
VC
Time frame: 2 months
FEV1/FVC
Time frame: 2 months
FEV1/VC
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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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.
Lauri Lehtimäki, Professor principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Tampere University Hospital at 1 site in Finland.
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 1 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 Feb 2022. 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 Finland. 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?
Viral load of SARS-CoV-2 from different sample sites (time frame: 0 months). The study lists 23 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 7 Feb 2022.