Study on Nitric Oxide and Saline Nasal Sprays for Treating COVID-19 and Similar Illnesses in Primary Care Patients

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What is this study about?

This clinical trial is focused on studying the treatment of COVID-19 and illnesses that resemble COVID-19, often referred to as COVID-like illnesses. The treatment being tested is a Nitric Oxide Nasal Spray (NONS), which is a nasal spray containing nitric oxide, a chemical substance. The study will also use a Saline Nasal Spray (0.9% NaCl), which is a simple saltwater solution, as a comparison. The purpose of the study is to evaluate how effective the Nitric Oxide Nasal Spray is in helping people recover from symptoms of COVID-19 or similar illnesses.

Participants in the study will use the nasal sprays for a period of up to seven days. During this time, researchers will monitor how quickly participants feel better from their symptoms and how the treatment affects the virus in their bodies. The study will also look at how the treatment impacts the severity of the illness and the body’s immune response. Participants will be asked to report when they first feel recovered and how their symptoms change over time.

The study aims to gather information on how the treatment affects daily activities and overall well-being. It will also explore any long-term effects of COVID-19 or similar illnesses, such as fatigue or loss of taste and smell. The trial will help researchers understand the potential benefits of using Nitric Oxide Nasal Spray in treating COVID-19 and related illnesses, providing valuable insights into managing these conditions in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, symptoms, and ability to comply with trial procedures.

Participants must have symptoms of COVID-19 or a similar illness, including both respiratory and systemic symptoms.

2 initial assessment

An initial assessment is conducted to evaluate the severity of symptoms and overall health status.

Participants are informed about the trial procedures and provide informed consent.

3 treatment phase

Participants receive a nitric oxide nasal spray or a saline nasal spray as a control.

The nasal spray is administered as per the trial protocol, with specific instructions on dosage and frequency provided to each participant.

4 monitoring and follow-up

Participants are monitored for symptom progression and recovery.

Self-reports on recovery and daily activities are collected to assess the impact of the treatment.

5 data collection

Data on viral clearance and symptom severity is collected at specified intervals, such as days 4, 7, and 14.

Participants may be required to store self-collected swabs at home for analysis.

6 end of trial participation

The trial concludes with a final assessment of recovery and any long-term effects.

Participants’ experiences and feedback on the trial are gathered for further analysis.

Who Can Join the Study?

Participant must be at least 18 years old on the day of joining the study.
Participant must have at least two symptoms that suggest COVID-19 or a similar illness. One symptom should be related to breathing, like a cough or sore throat, and another should be a general symptom, like fever or tiredness.
A doctor or qualified person must confirm that the illness is due to a breathing-related infection.
Symptoms must have started less than 7 days ago.
Participant must be willing and able to give their agreement to join the study.
Participant must be willing and able to follow all study procedures, including having a freezer at home to store self-collected samples.
For women who can have children, additional criteria may apply, such as pregnancy or breastfeeding. Women must use a reliable method of birth control or agree to abstain from sex for 30 days before and after joining the study.
For specific interventions, symptoms must have started within 3 days.
For specific interventions, women who can have children must be prepared to use an effective method of birth control or abstain from sex for 30 days before and after joining the study.

Who Cannot Join the Study?

Individuals who do not have symptoms of COVID-19 or a COVID-like illness cannot participate. This means if you don’t have symptoms similar to those caused by the COVID-19 virus, you are not eligible.
Participants must fall within certain age ranges. If you are not within the specified age groups, you cannot join the study.
Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
People considered part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care, such as those with certain health conditions or disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centro de Salud Mas Font	Barcelona	Spain

Other Sites

Site Name	City	Country
Medisch Huis Lange Leem 385	Antwerp	Belgium
Maresme	Mataró	Spain
Equip D’atencio Primaria Barcelona Sardenya S.L.P.	Barcelona	Spain
CAP 17 Setembre	Barcelona	Spain
The Crescent Medical Centre	Galway	Ireland
The Heights Medical Centre	Galway	Ireland
Main Street Clinic	Loughrea	Ireland
Centrum Medyczne Kleosin Wieliczko Sp. j.	Juchnowiec Koscielny	Poland
Medimed Sp. z o.o. Z Siedziba W Bialymstoku	Bialystok	Poland
Akademicka Praktyka Medycyny Rodzinnej Bielska Chlabicz Czarnowski Oltarzewska Sawicka-Powierza sp.p.	Bialystok	Poland
General Practice Dr. med Detief Schmitz	Erlenbach am Main	Germany
Nmih „msofuevx Redxwhgnu Awtorleqe Gcpo	Bialystok	Poland
Ndrm Srdkm scs Kyqwbvgsn Jlilhshlhwa Jipoblp Łafmwoyxdoseazsvrr	Bialystok	Poland
Pwqjfxrt Ltxforv Rjkjjhlxtv Jyuvrv Rfecyjzlxvbbj	Bialystok	Poland
Jjoww I	Tarragona	Spain
Rdyi dlaj Vromo	Barberà del Vallès	Spain
Sguv Mqznv da Pyxjtsmaab	Barcelona	Spain
Wbzqgxqrvzmyaybcxpoxxv &evluqpd Sbuqz	Borgerhout	Belgium
Hzryairnfv Wsgmdqprvz	Berchem	Belgium
Hrrkohqitsobrssrvq Bmib	Boom	Belgium
Vbwrs Mukfpw	Rijkevorsel	Belgium
Hvkezjqsgmsdswkgmz Zosyjtdet	Hoboken	Belgium
Puyjshqqpfwp Dw Gtife Rrwrhn	Deurne	Belgium
Hxdgvfubtvflhpktkr Bzkeizvjpolkbe	Turnhout	Belgium
Dj Hbifcx	Boechout	Belgium
Wwekprgftfbszijdwbdjvl Dx Vjcna	Sint-Niklaas	Belgium
Tocvtfq Pqffpod Cneb Cjkhad	Tramore	Ireland
Meezuqz Firdal Pxslefwe		Ireland
Gtspz Mohtbxc Cwjirl	Wexford	Ireland
Mhjfpyzwv Mvtjgsn Chvopo	Galway	Ireland
Hadqveqkwdwmrfmukc Pwpimm Mtbaseummao	Schilde	Belgium
Ahfptqsfstoinw Wbjsenpc	Kontich	Belgium
Mxxhiln Hokz Tnz Ltxkkc	Edegem	Belgium
Gjj ae Tkzvvbtj Cdaln	Dublin	Ireland
Cov Vwnh Vuvfh	Barcelona	Spain
Cfp Aqvgyigt	Barcelona	Spain
Csxvpw Hwhqxshuznr Eu Utdsnxqczquqm Da Lnstpxs	Limoges	France
Utuxoacskxhyihdzogqaf Wpbsijjfy Aph	Wuerzburg	Germany
Pyhjkm Tedq Jmog	Gössenheim	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.05.2024
France	Not recruiting	01.05.2024
Germany	Not recruiting	01.05.2024
Ireland	Not recruiting	01.05.2024
Poland	Not recruiting	01.05.2024
Spain	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

Remdesivir is an antiviral medication used to treat COVID-19. It works by interfering with the virus’s ability to replicate, which can help reduce the severity and duration of the illness. In this trial, it is being evaluated for its effectiveness in helping patients recover from COVID-19 symptoms and its impact on the virus’s presence in the body.

Dexamethasone is a corticosteroid that helps reduce inflammation in the body. It is used in the treatment of severe COVID-19 cases to help decrease the body’s inflammatory response, which can be harmful if it becomes too intense. The trial is assessing its role in improving recovery times and reducing illness severity.

Baricitinib is a medication that helps reduce inflammation by blocking certain enzymes in the body. It is being tested in this trial for its potential to improve recovery in COVID-19 patients by reducing the inflammatory response associated with the infection.

Tocilizumab is an immunosuppressive drug that targets specific proteins involved in inflammation. It is used to treat severe cases of COVID-19 where the immune system’s response is causing harm. The trial is investigating its effectiveness in reducing symptoms and improving recovery outcomes.

Favipiravir is an antiviral medication that inhibits the replication of the virus. It is being studied in this trial to determine its effectiveness in shortening the duration of COVID-19 symptoms and aiding in viral clearance from the body.

COVID-19 – COVID-19 is a respiratory illness caused by the coronavirus SARS-CoV-2. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. Symptoms can range from mild to severe and may include fever, cough, shortness of breath, fatigue, and loss of taste or smell. The disease can progress to pneumonia and acute respiratory distress syndrome in severe cases. Some individuals may experience long-term effects, known as “long COVID,” which can include fatigue, difficulty breathing, and cognitive issues. The progression and severity of symptoms can vary widely among individuals.

COVID-like illness – COVID-like illness refers to a set of symptoms that resemble those of COVID-19 but may not be caused by the SARS-CoV-2 virus. These symptoms can include fever, cough, sore throat, and shortness of breath. The illness can be caused by other respiratory viruses or conditions that mimic COVID-19 symptoms. The progression of symptoms can vary, with some individuals experiencing mild symptoms and others developing more severe respiratory issues. It is important to differentiate COVID-like illness from COVID-19 to ensure appropriate management and isolation measures. The term is often used in clinical settings to describe cases where COVID-19 has not been confirmed.

Trial ID:

2022-501707-27-01

Protocol code:

EU-EcraidPC-1

Trial Phase:

Therapeutic use (Phase IV)

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Study on Nitric Oxide and Saline Nasal Sprays for Treating COVID-19 and Similar Illnesses in Primary Care Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?