Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry

Study Overview
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Brief Summary
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The infection caused by COVID19 worldwide makes it necessary to monitor drugs administered for the treatment of patients hospitalized with SARS-CoV-2. In order to know more about the efficacy and safety of the treatments used, researchers from the Cantabrian health service have developed an observational study, in the form of an ambispective registry, in which clinical data from patients treated with the different drugs currently recommended by the Spanish Agency of Medicines and Health Products (SAMHP) and the Ministry of Health, or others that may arise, are collected and analyzed. Although the conduct of clinical trials is a priority at this time, we cannot lose the clinical experience that is currently being generated, which may allow us to improve the therapeutic strategies for future patients.

Official Title
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Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Drug: Patients with the treatment agains COVID19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of any age and gender, including minors and pregnant women. Hospital admission with diagnosis of COVID-19 according to clinical and microbiological criteria established by the Health Authorities and clinical practice (these may be modified based on the Technical Document. Clinical management of COVID-19: hospital care of the Ministry of Health). Patients receiving any specific treatment for COVID-19 disease (according to the Technical Document. Clinical management of COVID-19: medical treatment of the Ministry of Health, and Available treatments for the management of respiratory infection by SARS-CoV-2 of the AEMPS). Patients admitted but not receiving specific treatment for COVID-19 disease Exclusion Criteria: Patients who do not wish to give informed consent once requested.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving treatment for COVID19<br> | Drug: Patients with the treatment agains COVID19<br>* Data will be collected from patients who receive any of the treatments included in the Technical Document. Manejo clínico del COVID-19: tratamiento médico of the Ministry of Health, and Tratamientos disponibles para el manejo de la infección respiratoria por SARS-CoV-2 of the AEMPS, either as antivirals or as treatment of the inflammatory process in patients with SARS, or others as they arise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice | Measured in terms of clinical recovery | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication. |  | 6 months | 
| Information on the patterns of use of these drugs (dose, duration of treatment, | to know the use according to the Ministry of Health Technical Document | 6 months | 
| Adverse events | Adverse effects of the medicines used | 6 months | 
| Time of hospital admission and/or stay in ICU and maximum severity reached. |  | 6 months | 
| Treatments for SARS-CoV-2 positive patients not described in the protocol | Determine the evolution of the treatments | 6 months | 
| healthy survey for patients after their recovery/discharge from hospital. | It is composed of 10 items, with scores from 0 (worst health) to 100 points (best health) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, ICU