Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19

NCT06864156 | Recruiting

• 1 other identifier: 03/24 AD 2025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

At the moment, the number of people with long COVID is unkown because there is still no effective diagnosis. This is why is very important to analyze the most common symptoms, which are: depression, anxiety and fatigue. This project seeks to analyze some blood components of people with long COVID, such as microRNAs and vitamin B12, in order to identify the body processes that changed after COVID-19 and thereby design better therapies and diagnostic methods focused on each of them. The hypothesis is that the expression of miR-21, -146a and -155 will be overexpressed as well as there will be a deficiency of vitamin B12 in serum in subjects suffering from long COVID with neurological symptoms of depression, anxiety and fatigue.

Conditions

Long COVID; Long COVID Syndrome

Keywords

anxiety; depression; fatigue; microRNAs; vitamin b12; long covid

Outcome Measures

Primary Outcomes (4)

• Change of microRNA expression between long COVID group and control group

  immediately after the blood extraction

• Change of vitamin B12 concentration between long COVID group and control group

  immediately after the blood extraction

• Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue

  immediately after the blood extraction

• Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue.

  immediately after the blood extraction

Study Arms (2)

Long COVID

With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 three months after the first day with symptoms of acute infection

Control

Not presented symptoms associated with COVID-19 twelve weeks after the first day with symptoms of acute infection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with symptoms of depression, anxiety and fatigue after having had COVID-19

You may qualify if:

• Subjects with confirmed diagnosis of COVID-19 by SARS-CoV-2 infection by PCR or antigen testing.
• With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 after three months from the first day of acute infection symptoms.

You may not qualify if:

• Subjects who have presented symptoms of acute infection in the last twelve weeks.
• Subjects who present diagnostic premorbid neurological alterations.
• Subjects who do not have at least 2 doses of COVID-19 vaccine, with last application date equal or older than 3 months.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitación

Mexico City, Mexico City, 14389, Mexico

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 7, 2025
• Study Start: February 18, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

ME (1)