NCT04728919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 19, 2021

Last Update Submit

February 4, 2022

Conditions

COVID-19SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (23)

  • Viral load of SARS-CoV-2 from different sample sites

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

    0 months

  • Upper respiratory tract viruses

    RT-PCR-multiplex tests, from nasopharyngeal sample site

    0 months

  • FeNO

    Fractional exhaled nitric oxide in ppb obtained NIOX VERO

    Baseline

  • FnNO

    Nasal nitric oxide in ppb obtained NIOX VERO

    Baseline

  • FeNO

    Fractional exhaled nitric oxide in ppb obtained NIOX VERO

    2 months

  • Change in FeNO

    FeNO at 2 months - FeNO at baseline

    BAseline and at 2 months

  • FnNO

    Nasal nitric oxide in ppb obtained NIOX VERO

    2 months

  • CHange in FnNO

    FnNO at 2 moths - FnNO at baseline

    Baseline and at 2 months

  • Airway resistance at 20Hz, R20

    Airway resistance at 20Hz obtained from Impulse oscillometry

    Baseline

  • Airway resistance at 5Hz, R5

    Airway resistance at 5Hz obtained from Impulse oscillometry

    Baseline

  • Airway resistance at 20 Hz, R20

    Airway resistance at 20 Hz obtained from Impulse oscillometry

    2 months

  • Change in R20

    R20 at 2 months - R20 at baseline

    Baseline and at 2 months

  • Airway resistance at 5Hz, R5

    Airway resistance at 5Hz obtained from Impulse oscillometry

    2 months

  • Change in R5

    R5 at 2 months - R5 at baseline

    Baseline and at 2 months

  • Reactance at 5Hz (X5)

    Airway reactance at 5 Hz obtained from Impulse oscillometry

    Baseline

  • Reactance at 5Hz (X5)

    Airway reactance at 5 Hz obtained from Impulse oscillometry

    2 months

  • Change in X5

    X5 at 2 months - X5 at baseline

    Baseline and at 2 months

  • Resonant frequency (Fres)

    Resonant frequency (Fres) obtained from Impulse oscillometry

    Baseline

  • Resonant frequency (Fres)

    Resonant frequency (Fres) obtained from Impulse oscillometry

    2 months

  • Change in Fres

    Fres at 2 months - Fres at baseline

    Baseline and at 2 months

  • Reactance area (AХ)

    Reactance area (AХ) obtained from Impulse oscillometry

    Baseline

  • Reactance area (AХ)

    Reactance area (AХ) obtained from Impulse oscillometry

    2 months

  • Change in AX

    AX at 2 months - AX at baseline

    Baseline and at 2 months

Secondary Outcomes (5)

  • FEV1

    2 months

  • FVC

    2 months

  • VC

    2 months

  • FEV1/FVC

    2 months

  • FEV1/VC

    2 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptoms of COVID-19 infection

You may qualify if:

  • 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

You may not qualify if:

  • need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lauri Lehtimäki, Professor

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 28, 2021

Study Start

January 15, 2021

Primary Completion

January 15, 2023

Study Completion

January 15, 2024

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations

FI(1)