Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

• Conditions: COVID-19; SARS-CoV-2 Infection

• Registration Number: NCT04728919
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07
• Primary Completion: 2023-01-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral load of SARS-CoV-2 from different sample sites	0 months	RT-PCR (Ct value) and antigen testing (RLU value)
FnNO	2 months	Nasal nitric oxide in ppb obtained NIOX VERO
Change in FeNO	BAseline and at 2 months	FeNO at 2 months - FeNO at baseline
Change in R20	Baseline and at 2 months	R20 at 2 months - R20 at baseline
Upper respiratory tract viruses	0 months	RT-PCR-multiplex tests, from nasopharyngeal sample site
FeNO	2 months	Fractional exhaled nitric oxide in ppb obtained NIOX VERO
Airway resistance at 5Hz, R5	2 months	Airway resistance at 5Hz obtained from Impulse oscillometry
CHange in FnNO	Baseline and at 2 months	FnNO at 2 moths - FnNO at baseline
Airway resistance at 20Hz, R20	Baseline	Airway resistance at 20Hz obtained from Impulse oscillometry
Airway resistance at 20 Hz, R20	2 months	Airway resistance at 20 Hz obtained from Impulse oscillometry
Change in R5	Baseline and at 2 months	R5 at 2 months - R5 at baseline
Reactance at 5Hz (X5)	2 months	Airway reactance at 5 Hz obtained from Impulse oscillometry
Resonant frequency (Fres)	2 months	Resonant frequency (Fres) obtained from Impulse oscillometry
Change in X5	Baseline and at 2 months	X5 at 2 months - X5 at baseline
Change in Fres	Baseline and at 2 months	Fres at 2 months - Fres at baseline
Reactance area (AХ)	2 months	Reactance area (AХ) obtained from Impulse oscillometry
Change in AX	Baseline and at 2 months	AX at 2 months - AX at baseline

Secondary Outcome Measures

Name	Time	Method
FEV1/VC	2 months	Forced expiratory volume in 1 second divided by vital capacity
FEV1	2 months	Forced expiratory volume in 1 second
VC	2 months	Vital capacity
FEV1/FVC	2 months	Forced expiratory volume in 1 second divided by forced vital capacity
FVC	2 months	Forced vital capacity

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland