Clinical trial NCT04728919: Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
Official title: Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS-CoV-2 Infection
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms of COVID-19 infection

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral load of SARS-CoV-2 from different sample sites
timeFrame: 0 months
measure: Upper respiratory tract viruses
timeFrame: 0 months
measure: FeNO
timeFrame: Baseline
measure: FnNO
timeFrame: Baseline
measure: FeNO
timeFrame: 2 months
measure: Change in FeNO
timeFrame: BAseline and at 2 months
measure: FnNO
timeFrame: 2 months
measure: CHange in FnNO
timeFrame: Baseline and at 2 months
measure: Airway resistance at 20Hz, R20
timeFrame: Baseline
measure: Airway resistance at 5Hz, R5
timeFrame: Baseline
measure: Airway resistance at 20 Hz, R20
timeFrame: 2 months
measure: Change in R20
timeFrame: Baseline and at 2 months
measure: Airway resistance at 5Hz, R5
timeFrame: 2 months
measure: Change in R5
timeFrame: Baseline and at 2 months
measure: Reactance at 5Hz (X5)
timeFrame: Baseline
measure: Reactance at 5Hz (X5)
timeFrame: 2 months
measure: Change in X5
timeFrame: Baseline and at 2 months
measure: Resonant frequency (Fres)
timeFrame: Baseline
measure: Resonant frequency (Fres)
timeFrame: 2 months
measure: Change in Fres
timeFrame: Baseline and at 2 months
measure: Reactance area (AХ)
timeFrame: Baseline
measure: Reactance area (AХ)
timeFrame: 2 months
measure: Change in AX
timeFrame: Baseline and at 2 months
Secondary outcomes:
measure: FEV1
timeFrame: 2 months
measure: FVC
timeFrame: 2 months
measure: VC
timeFrame: 2 months
measure: FEV1/FVC
timeFrame: 2 months
measure: FEV1/VC
timeFrame: 2 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Lauri Lehtimäki, Professor
role: PRINCIPAL_INVESTIGATOR
References: