Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

COVID-19 Clinical Trial

Official title:

Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04728919
• Other study ID #: R200090
• Status: Active, not recruiting
• Start date: January 15, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load of SARS-CoV-2 from different sample sites	RT-PCR (Ct value) and antigen testing (RLU value)	0 months
Primary	Upper respiratory tract viruses	RT-PCR-multiplex tests, from nasopharyngeal sample site	0 months
Primary	FeNO	Fractional exhaled nitric oxide in ppb obtained NIOX VERO	Baseline
Primary	FnNO	Nasal nitric oxide in ppb obtained NIOX VERO	Baseline
Primary	FeNO	Fractional exhaled nitric oxide in ppb obtained NIOX VERO	2 months
Primary	Change in FeNO	FeNO at 2 months - FeNO at baseline	BAseline and at 2 months
Primary	FnNO	Nasal nitric oxide in ppb obtained NIOX VERO	2 months
Primary	CHange in FnNO	FnNO at 2 moths - FnNO at baseline	Baseline and at 2 months
Primary	Airway resistance at 20Hz, R20	Airway resistance at 20Hz obtained from Impulse oscillometry	Baseline
Primary	Airway resistance at 5Hz, R5	Airway resistance at 5Hz obtained from Impulse oscillometry	Baseline
Primary	Airway resistance at 20 Hz, R20	Airway resistance at 20 Hz obtained from Impulse oscillometry	2 months
Primary	Change in R20	R20 at 2 months - R20 at baseline	Baseline and at 2 months
Primary	Airway resistance at 5Hz, R5	Airway resistance at 5Hz obtained from Impulse oscillometry	2 months
Primary	Change in R5	R5 at 2 months - R5 at baseline	Baseline and at 2 months
Primary	Reactance at 5Hz (X5)	Airway reactance at 5 Hz obtained from Impulse oscillometry	Baseline
Primary	Reactance at 5Hz (X5)	Airway reactance at 5 Hz obtained from Impulse oscillometry	2 months
Primary	Change in X5	X5 at 2 months - X5 at baseline	Baseline and at 2 months
Primary	Resonant frequency (Fres)	Resonant frequency (Fres) obtained from Impulse oscillometry	Baseline
Primary	Resonant frequency (Fres)	Resonant frequency (Fres) obtained from Impulse oscillometry	2 months
Primary	Change in Fres	Fres at 2 months - Fres at baseline	Baseline and at 2 months
Primary	Reactance area (A?)	Reactance area (A?) obtained from Impulse oscillometry	Baseline
Primary	Reactance area (A?)	Reactance area (A?) obtained from Impulse oscillometry	2 months
Primary	Change in AX	AX at 2 months - AX at baseline	Baseline and at 2 months
Secondary	FEV1	Forced expiratory volume in 1 second	2 months
Secondary	FVC	Forced vital capacity	2 months
Secondary	VC	Vital capacity	2 months
Secondary	FEV1/FVC	Forced expiratory volume in 1 second divided by forced vital capacity	2 months
Secondary	FEV1/VC	Forced expiratory volume in 1 second divided by vital capacity	2 months