Respiratory Viral InfectionNCT04681001
Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers
A study testing nasal spray in people with Respiratory Viral Infection and Common Cold, run by Marinomed Biotech AG at 2 sites in Austria.
Trial summary
This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Viral Infection, Common Cold, Severe Acute Respiratory Syndrome (SARS) Pneumonia
- What is being tested?
- nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesAustria
- Study dates
- 20 Dec 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Study participants that have given informed consent before any study related procedures are performed, and received a copy of signed consent form
- Healthcare workers (nurses, doctors) employed and working at Gesundheitsverbund
- Healthcare workers looking after confirmed COVID-19 positive patients in a secondary care setting such as Accident and Emergency departments, wards, operating theatres, outpatient departments, High Dependency Unit or Intensive Care Units
Who cannot join
- The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor.
- The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
- Known hypersensitivity or allergy to any component of the test product
- Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion.
- The subject has a clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions include immune deficiency, autoimmune disease, substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease.
- Asymptomatic disease such as elevated blood pressure or cholesterol will not be a reason for exclusion. Those with well-controlled mental illness (e.g. depression, anxiety) will be eligible. The enrolling physician will be empowered to exclude potential subjects that s/he deems unreliable.
Show all 9Show fewer
- Pregnant women at the time of recruitment will be excluded from the study
- Current medication other than oral contraception, that is considered by the investigator as a reason for exclusion e.g. intranasal medication
- Participation in another antiviral clinical trial
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Gesundheitsverbund, Klinik Favoriten
Vienna, 1100
Gesundheitsverbund Klinik Floridsdorf
Vienna, 1210
About this study
Official title: Clinical Trial to Evaluate the Efficacy of an Iota-Carrageenan Nasal Spray to Reduce Symptoms Caused by SARS-CoV-2 and Other Respiratory Viruses in Healthcare Workers Managing COVID-19 Patients
This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.
Read the detailed description
This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients.
Screening - first day of treatment:
After signing the informed consent form eligible participants will be included. Immediately after inclusion and after first nasal swab, participants start with their first treatment.
In order to obtain nasal swabs and to assess adverse events the participants will visit the sites on a weekly basis over a period of 12 weeks.
3 times a day for 84 days (12 weeks):
- 1 puff of Coldamaris pro. nasal spray into each nostril (1.2 mg/ml; 140 µl per puff) and
- 3 puffs of Coldamaris pro. nasal spray into mouth Weekly sampling for testing of SARS-CoV-2 and respiratory virus panel (Influenza A, Human Metapneumovirus, Influenza A - subtype H1 Adenovirus, Influenza A - subtype H3 Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B Parainfluenza 3, SARS-CoV-2 Parainfluenza 4, Coronavirus HKU1 Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus) At begin and end of trial blood samples will be taken for differential blood count and for serology. The primary end point of the is the presence of COVID-19 symptoms including symptoms of respiratory viral infection. The primary hypothesis is a reduction of symptom days caused by SARS-CoV-2 and/or respiratory viral infection in health care workers treated with Coldamaris pro. nasal spray compared to placebo treated ones
- Conditions
- Respiratory Viral Infection, Common Cold, Severe Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19, Corona Virus Disease
- Being tested
- nasal spray
- Keywords
- Carragelose, Respiratory Virus, Iota-Carrageenan, Health CareWorker, Frontline Worker, Nasal Spray
- Medical subject headings
- Common Cold, Severe Acute Respiratory Syndrome, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal sprayDevice
application of nasal spray into nostrils and mouth
| Study group | Role | What they receive |
|---|---|---|
| Coldamaris pro | Experimental | One puff per nostril three puffs into mouth Receives: Device: nasal spray |
| Coldamaris sine | Placebo comparator | One puff per nostril three puffs into mouth Receives: Device: nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary
daily assessment of subjective COVID-19 symptom score
Measured: 84 days
Secondary outcomes (3)
Nasal swabs for analysis of viruses by PCR
weekly assessment of SARS-CoV-2, Influenza A, Human Metapneumovirus, Influenza A - subtype H1, Adenovirus, Influenza A - subtype H3, Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B, Parainfluenza 3, Parainfluenza 4, Coronavirus HKU1, Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila
Measured: 84 days
Serology of antibodies against SARS-CoV-2
beginn and end of trial
Measured: 84 days
Number of viral co-infections dedected by PCR
weekly nasal swabs for analysis of viruses
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start20 Dec 2020
- Primary completion20 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled double blinded
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinomed Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iulia Niculescu, MD, Principal investigator, Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681001
- Sponsor's protocol ID
- COVID-19/CHC_20_04
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy of an Iota-Carrageenan Nasal Spray to Reduce Symptoms Caused by SARS-CoV-2 and Other Respiratory Viruses in Healthcare Workers Managing COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04681001
- Acronym / sponsor ID
- COVID-19/CHC_20_04
- Conditions
- Respiratory Viral Infection, Common Cold, Severe Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19, Corona Virus Disease
- Keywords
- Carragelose, Respiratory Virus, Iota-Carrageenan, Health CareWorker, Frontline Worker, Nasal Spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Marinomed Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.
Detailed description
This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients.
Screening - first day of treatment:
After signing the informed consent form eligible participants will be included. Immediately after inclusion and after first nasal swab, participants start with their first treatment.
In order to obtain nasal swabs and to assess adverse events the participants will visit the sites on a weekly basis over a period of 12 weeks.
3 times a day for 84 days (12 weeks):
- 1 puff of Coldamaris pro. nasal spray into each nostril (1.2 mg/ml; 140 µl per puff) and
- 3 puffs of Coldamaris pro. nasal spray into mouth Weekly sampling for testing of SARS-CoV-2 and respiratory virus panel (Influenza A, Human Metapneumovirus, Influenza A - subtype H1 Adenovirus, Influenza A - subtype H3 Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B Parainfluenza 3, SARS-CoV-2 Parainfluenza 4, Coronavirus HKU1 Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus) At begin and end of trial blood samples will be taken for differential blood count and for serology. The primary end point of the is the presence of COVID-19 symptoms including symptoms of respiratory viral infection. The primary hypothesis is a reduction of symptom days caused by SARS-CoV-2 and/or respiratory viral infection in health care workers treated with Coldamaris pro. nasal spray compared to placebo treated ones
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double blinded
| Arm | Type | Receives |
|---|---|---|
| Coldamaris pro | Experimental | Device: nasal sprayOne puff per nostril three puffs into mouth |
| Coldamaris sine | Placebo comparator | Device: nasal sprayOne puff per nostril three puffs into mouth |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Study participants that have given informed consent before any study related procedures are performed, and received a copy of signed consent form
- Healthcare workers (nurses, doctors) employed and working at Gesundheitsverbund
- Healthcare workers looking after confirmed COVID-19 positive patients in a secondary care setting such as Accident and Emergency departments, wards, operating theatres, outpatient departments, High Dependency Unit or Intensive Care Units
Key exclusion criteria (9 listed)
- The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor.
- The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
- Known hypersensitivity or allergy to any component of the test product
- Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion.
- The subject has a clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions include immune deficiency, autoimmune disease, substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal sprayapplication of nasal spray into nostrils and mouth | Device | Coldamaris pro, Coldamaris sine |
Primary outcome
Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary
Time frame: 84 days
daily assessment of subjective COVID-19 symptom score
3 secondary outcomes
Nasal swabs for analysis of viruses by PCR
Time frame: 84 days
Serology of antibodies against SARS-CoV-2
Time frame: 84 days
Number of viral co-infections dedected by PCR
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Respiratory Viral Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iulia Niculescu, MD principal investigator
Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal spray in people with Respiratory Viral Infection and Common Cold, run by Marinomed Biotech AG at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.