Official Title
Persistent COVID-19 Registry in Navarre. (Persicov-19)
Brief Summary

The goal of this observational study is to deepen our understanding of long COVID bydetermining the prevalence of the main complications and medium- to long-term sequelae ofCOVID-19 in Navarre.Sociodemographic variables such as age, sex, ethnicity, smoking history, andcomorbidities will be collected, as well as clinical and disease management variablessuch as persistent COVID-19 symptoms at 3 months, all with the aim of characterizingpatients with long COVID.All patient data will be collected in a single visit.

Detailed Description

COVID-19 is the largest pandemic faced by the public health system in the last hundred
years. The medium- and long-term consequences of SARS-COV-2 infection are currently
unknown. Studies on coronavirus-induced lung damage in previous epidemics such as
SARS-CoV and MERS-CoV have shown an increase in morbidity and mortality due to pulmonary
fibrosis as a consequence of adult respiratory distress syndrome (ARDS) caused by these
viruses. COVID-19 has also been shown to be a multisystemic disease with the potential to
affect multiple organs or systems, damaged directly by the virus and/or indirectly by a
dysfunctional immune response and/or by the supportive therapies used.

The healthcare system is currently focusing on the acute care of this disease, but
continuous monitoring of these patients is necessary since many of them continue to have
symptoms after the acute phase of the disease, known as persistent COVID-19 or long
COVID. Long COVID or persistent COVID is the term used to describe the disease in people
who have recovered from the disease but still report lasting effects from the infection
or who have symptoms for longer than would be expected².

The study published by Carfi et al, conducted in a hospital in Rome, has shown that 9 out
of 10 patients (87%) who had been discharged from hospital with COVID-19 60 days after
discharge still reported at least one symptom of COVID-19³.

The investigators believe that once this peak phase of the epidemic has passed, it is
very important to monitor the progress of patients who have suffered a moderate or severe
infection in order to assess the presence of complications in the medium and short term.
For this reason, it is necessary to implement a coordinated care protocol for patients
diagnosed with persistent COVID-19 or with sequelae, involving both primary and hospital
care, with a specific monographic consultation, as has been done in other centres⁴ and as
agreed between the Spanish Society of Internal Medicine (SEMI) and the Spanish Society of
Primary Care Physicians (SEMERGEN)⁵.

The establishment of a specific care pathway for persistent COVID patients, together with
the creation of a registry of these patients that collects information on their
demographic and clinical characteristics, will make it possible to determine the
prevalence of complications in this population and will provide the infrastructure and
basis necessary for carrying out future short- to medium-term clinical projects aimed at
the prevention and treatment of persistent COVID disease in Navarra.

The overall objective of this project is to deepen our understanding of persistent COVID
disease in our environment. This overall objective will be carried out in accordance with
the following specific objectives:

1. Establish an effective and coordinated care pathway between primary care and
hospital care specifically for persistent COVID patients, facilitating comprehensive
care and follow-up while avoiding duplication and overlap of consultations.

2. Generate a registry of patients with persistent COVID-19 in Navarre (PersiCOV-19)
through the prospective collection of sociodemographic, clinical, and analytical
information on these patients.

3. Describe the demographic, clinical, and analytical characteristics of patients with
persistent COVID in our setting.

4. Establish the prevalence of different symptoms, complications and/or medium- to
long-term sequelae of COVID-19 in Navarre.

5. Record the use of the different therapeutic options used to prevent and/or treat
potential complications.

6. Analyse the possible factors that condition the presence of certain complications.

The work plan is as follows:

Register patients seen in outpatient consultations at the Internal Medicine Department of
the Navarra Hospital Complex who have been referred from Primary Care, from the Internal
Medicine Department of the Navarra Hospital Complex itself, or from other departments.

Patient registration will begin in January 2021 and end in December 2026. Patients
assessed by Primary Care Teams (Primary Care Physician or Case Management Nurse) who
present symptoms compatible with persistent Covid will be referred to the Internal
Medicine clinic.

Patients who have been assessed in outpatient clinics by professionals from other
specialities and who present symptoms compatible with persistent Covid will be referred
to the Internal Medicine clinic.

It is recommended that patients undergo the following procedures before referral:

- a clinical assessment questionnaire (Annex 1), which may be conducted by telephone
and/or in person

- a blood test including a complete blood count, coagulation, CRP, ferritin, LDH,
liver and kidney profile

- a chest X-ray.

If they do not have these, they will be carried out at the Internal Medicine clinic.

If the symptoms are debilitating and prevent the patient from carrying out an active
working and daily life, they may be referred to the Internal Medicine clinic on a
priority basis within 3 months.

This study is an observational, descriptive, cross-sectional, prospective cohort study
that will include patients seen in the outpatient clinic of the Internal Medicine
department who have been referred from primary care teams or other departments.

The sociodemographic and clinical characteristics of the study population and the
treatments received will be described using descriptive statistics such as mean and
standard deviation or median and interquartile range for continuous variables, depending
on their nature, and frequencies and percentages for categorical variables. The
prevalence of certain complications and sequelae in this population will be estimated
using frequencies and their 95% CI. If any comparisons are made between patients with
certain complications, these will be performed using parametric techniques such as
Student's t-test or non-parametric techniques such as Mann-Whitney's U test for
quantitative variables and the Chi-square test or Fisher's test for qualitative
variables. Data analysis will be performed using statistical programmes such as the free
software R 4.0.2 or IBM SPSS Statistics 21.

The fact that the registry is an observational study of a single cohort of patients with
persistent COVID (without a comparison group) will have limitations in that it will not
be possible to establish risk factors or possible causes related to the development of
persistent COVID, and the investigators may encounter biases such as sample selection and
recall bias.

Recruiting
Long COVID Symptoms
Long COVI
Eligibility Criteria

Inclusion Criteria:

- History of confirmed SARS-CoV-2 infection

- Presentation of symptoms that have persisted for more than 3 months after SARS-CoV-2
infection

- The patient reports any of the symptoms listed in the clinical assessment
questionnaire or checklist.

Exclusion Criteria:

- The symptom(s) referred to already existed prior to acute SARS-CoV-2 infection.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Spain
Locations

Hospital Universitario de Navarra
Pamplona, Navarre, Spain

Investigator: Patricia Fanlo Mateo., MD, PhD
Contact: +34639668497
patricia.fanlo.mateo@navarra.es

Investigator: Patricia Fanlo Mateo, MD, PhD

Contacts

Ruth García Rey, SC
+3484822163
ruth.garcia.rey@navarra.es

Patricia Fanlo Mateo, MD, PhD, Principal Investigator
Hospital Universitario de Navarra. Pamplona. Spain

Fundacion Miguel Servet
NCT Number
Keywords
long covid 19
Long COVID syndrome
Long COVID fatigue