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Status unknownNCT04347278RegCOVID19Updated Sep 16, 2021

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

An observational study in SARS-CoV-2, sponsored by Instituto de Investigación Marqués de Valdecilla. Status unknown at 1 site in Spain. Open to participants aged 1 Year to 100 Years. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Instituto de Investigación Marqués de Valdecilla · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,000
Ages
1 Year to 100 Years
Sex
All
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Study 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.

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Conditions studied

  • SARS-CoV-2

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Keywords

  • COVID19
  • ICU
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 100 Years
Sexes eligible
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).

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

Exclusion Criteria:

  • Patients who do not wish to give informed consent once requested.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Patients receiving treatment for COVID19

    Drug: Patients with the treatment agains COVID19

Interventions

  • DrugPatients 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  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,

    to know the use according to the Ministry of Health Technical Document

    Time frame: 6 months

  3. Adverse events

    Adverse effects of the medicines used

    Time frame: 6 months

  4. Time of hospital admission and/or stay in ICU and maximum severity reached.

    Time frame: 6 months

  5. Treatments for SARS-CoV-2 positive patients not described in the protocol

    Determine the evolution of the treatments

    Time frame: 6 months

  6. 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)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
    • MAR GARCIA · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04347278
Lead sponsor
Instituto de Investigación Marqués de Valdecilla
Collaborators
Hospital Universitario Marqués de Valdecilla, Hospital Universitario de Canarias, Hospital San Pedro de Alcantara
Responsible party
Sponsor
First posted
Apr 15, 2020
Start date
Apr 22, 2020
Primary completion
Oct 15, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Sep 16, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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