Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

Sponsor
Tampere University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04728919
Collaborator
(none)
82
1
36
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    82 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
    Actual Study Start Date :
    Jan 15, 2021
    Anticipated Primary Completion Date :
    Jan 15, 2023
    Anticipated Study Completion Date :
    Jan 15, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Viral load of SARS-CoV-2 from different sample sites [0 months]

      RT-PCR (Ct value) and antigen testing (RLU value)

    2. Upper respiratory tract viruses [0 months]

      RT-PCR-multiplex tests, from nasopharyngeal sample site

    3. FeNO [Baseline]

      Fractional exhaled nitric oxide in ppb obtained NIOX VERO

    4. FnNO [Baseline]

      Nasal nitric oxide in ppb obtained NIOX VERO

    5. FeNO [2 months]

      Fractional exhaled nitric oxide in ppb obtained NIOX VERO

    6. Change in FeNO [BAseline and at 2 months]

      FeNO at 2 months - FeNO at baseline

    7. FnNO [2 months]

      Nasal nitric oxide in ppb obtained NIOX VERO

    8. CHange in FnNO [Baseline and at 2 months]

      FnNO at 2 moths - FnNO at baseline

    9. Airway resistance at 20Hz, R20 [Baseline]

      Airway resistance at 20Hz obtained from Impulse oscillometry

    10. Airway resistance at 5Hz, R5 [Baseline]

      Airway resistance at 5Hz obtained from Impulse oscillometry

    11. Airway resistance at 20 Hz, R20 [2 months]

      Airway resistance at 20 Hz obtained from Impulse oscillometry

    12. Change in R20 [Baseline and at 2 months]

      R20 at 2 months - R20 at baseline

    13. Airway resistance at 5Hz, R5 [2 months]

      Airway resistance at 5Hz obtained from Impulse oscillometry

    14. Change in R5 [Baseline and at 2 months]

      R5 at 2 months - R5 at baseline

    15. Reactance at 5Hz (X5) [Baseline]

      Airway reactance at 5 Hz obtained from Impulse oscillometry

    16. Reactance at 5Hz (X5) [2 months]

      Airway reactance at 5 Hz obtained from Impulse oscillometry

    17. Change in X5 [Baseline and at 2 months]

      X5 at 2 months - X5 at baseline

    18. Resonant frequency (Fres) [Baseline]

      Resonant frequency (Fres) obtained from Impulse oscillometry

    19. Resonant frequency (Fres) [2 months]

      Resonant frequency (Fres) obtained from Impulse oscillometry

    20. Change in Fres [Baseline and at 2 months]

      Fres at 2 months - Fres at baseline

    21. Reactance area (AХ) [Baseline]

      Reactance area (AХ) obtained from Impulse oscillometry

    22. Reactance area (AХ) [2 months]

      Reactance area (AХ) obtained from Impulse oscillometry

    23. Change in AX [Baseline and at 2 months]

      AX at 2 months - AX at baseline

    Secondary Outcome Measures

    1. FEV1 [2 months]

      Forced expiratory volume in 1 second

    2. FVC [2 months]

      Forced vital capacity

    3. VC [2 months]

      Vital capacity

    4. FEV1/FVC [2 months]

      Forced expiratory volume in 1 second divided by forced vital capacity

    5. FEV1/VC [2 months]

      Forced expiratory volume in 1 second divided by vital capacity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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
    Exclusion Criteria:
    • need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere University Hospital Tampere Finland

    Sponsors and Collaborators

    • Tampere University Hospital

    Investigators

    • Principal Investigator: Lauri Lehtimäki, Professor, Tampere University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lauri Lehtimäki, associate professor, Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT04728919
    Other Study ID Numbers:
    • R200090
    First Posted:
    Jan 28, 2021
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2022