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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 (RegCOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347278
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
Hospital Universitario Marqués de Valdecilla
Hospital Universitario de Canarias
Hospital San Pedro de Alcántara
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

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.


Condition or disease Intervention/treatment
SARS-CoV-2 Drug: Patients with the treatment agains COVID19

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication. [ Time Frame: 6 months ]
  2. 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

  3. Adverse events [ Time Frame: 8 months ]
    Adverse effects of the medicines used

  4. Time of hospital admission and/or stay in ICU and maximum severity reached. [ Time Frame: 8 months ]
  5. Treatments for SARS-CoV-2 positive patients not described in the protocol [ Time Frame: 8 months ]
    Determine the evolution of the treatments

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

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


Contacts
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Contact: MARIA DEL MAR GARCIA SAIZ, MDPhD 942203333 mmar.garcia@scsalud.es
Contact: LUCIA LAVIN ALCONERO, Phd 942203373 eclinicos5@idival.org

Locations
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Spain
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Contact: MAR GARCIA         
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Hospital Universitario Marqués de Valdecilla
Hospital Universitario de Canarias
Hospital San Pedro de Alcántara
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Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT04347278    
Other Study ID Numbers: IDI-REM-2020-1
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Marqués de Valdecilla:
COVID19
ICU