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The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.
This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.
The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMUNOR | Experimental | Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMUNOR | Drug | The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of COVID-19 disease | The incidence of COVID-19 disease among the studied population will be assessed. | 6 or 12 weeks |
| Prevention of hospitalisations due to COVID-19 | The number of study subjects requiring hospitalisation due to COVID-19 will be observed | 6 or 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sick-leave episodes | The number of study subjects requiring a sick-leave due to COVID-19 will be observed | 6 or 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JaromÃr Bystroň, Ass.Prof.,MD,CSc. | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
There is no plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C520221 | IMUNOR |
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The study treatment (IMUNOR) will be administered to one group of study subjects only.
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No masking will be used in the study
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |