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 (RegCOVID19)
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|ClinicalTrials.gov Identifier: NCT04347278|
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : June 2, 2020
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.
|Condition or disease||Intervention/treatment|
|SARS-CoV-2||Drug: Patients with the treatment agains COVID19|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||6 Months|
|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|
|Actual Study Start Date :||April 22, 2020|
|Estimated Primary Completion Date :||October 15, 2020|
|Estimated Study Completion Date :||January 1, 2021|
|Patients receiving treatment for COVID19||
Drug: Patients with the treatment agains COVID19
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.
- Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice [ Time Frame: 6 months ]measured in terms of clinical stability
- Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice [ Time Frame: 6 months ]measured in terms of clinical recovery
- Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice [ Time Frame: 6 months ]measured in terms of clinical mortality.
- Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication. [ Time Frame: 6 months ]
- Information on the patterns of use of these drugs (dose, duration of treatment, [ Time Frame: 8 months ]to know the use according to the Ministry of Health Technical Document
- Adverse events [ Time Frame: 8 months ]Adverse effects of the medicines used
- Time of hospital admission and/or stay in ICU and maximum severity reached. [ Time Frame: 8 months ]
- Treatments for SARS-CoV-2 positive patients not described in the protocol [ Time Frame: 8 months ]Determine the evolution of the treatments
- healthy survey for patients after their recovery/discharge from hospital. [ Time Frame: 6 months ]It is composed of 10 items, with scores from 0 (worst health) to 100 points (best health)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347278
|Contact: MARIA DEL MAR GARCIA SAIZ, MDPhDfirstname.lastname@example.org|
|Contact: LUCIA LAVIN ALCONERO, Phdemail@example.com|
|Hospital Universitario Marqués de Valdecilla||Recruiting|
|Santander, Cantabria, Spain, 39008|
|Contact: MAR GARCIA|