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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.
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coldamaris pro | Experimental | One puff per nostril three puffs into mouth |
|
| Coldamaris sine | Placebo Comparator | One puff per nostril three puffs into mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal spray | Device | application of nasal spray into nostrils and mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary | daily assessment of subjective COVID-19 symptom score | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iulia Niculescu, MD | Gesundheitsverbund; Klinik Favoriten;4. Medizinische Abteilung mit Infektions-und Tropenmedizin1100 Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gesundheitsverbund, Klinik Favoriten | Vienna | 1100 | Austria | |||
| Gesundheitsverbund Klinik Floridsdorf |
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Randomized placebo-controlled double blinded
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| 84 days |
| Serology of antibodies against SARS-CoV-2 | beginn and end of trial | 84 days |
| Number of viral co-infections dedected by PCR | weekly nasal swabs for analysis of viruses | 84 days |
| Vienna |
| 1210 |
| Austria |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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