Clinical trial NCT04347278: 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
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Keywords: COVID19
ICU
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Marqués de Valdecilla
name: Hospital Universitario de Canarias
name: Hospital San Pedro de Alcantara
First posted: 2020-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject of the study is any person diagnosed with COVID-19 who is admitted to a hospital either as an inpatient or in an intensive care unit (ICU).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice
timeFrame: 6 months
Secondary outcomes:
measure: Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.
timeFrame: 6 months
measure: Information on the patterns of use of these drugs (dose, duration of treatment,
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Time of hospital admission and/or stay in ICU and maximum severity reached.
timeFrame: 6 months
measure: Treatments for SARS-CoV-2 positive patients not described in the protocol
timeFrame: 6 months
measure: healthy survey for patients after their recovery/discharge from hospital.
timeFrame: 6 months
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
Study officials:
References: