Long COVIDNCT06864156
Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19
An observational study of Long COVID and Long COVID Syndrome, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Long COVID Syndrome
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 18 Feb 2025to Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with symptoms of depression, anxiety and fatigue after having had COVID-19
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Rehabilitación
Mexico City, Mexico City, 14389
Alfonso Alfaro Rodriguez, Doctorado, 55 5999 1000 ext. 19305, alfa1360@yahoo.com.mx
About this study
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
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of microRNA expression between long COVID group and control group
Measured: immediately after the blood extraction
Change of vitamin B12 concentration between long COVID group and control group
Measured: immediately after the blood extraction
Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue
Measured: immediately after the blood extraction
Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue.
Measured: immediately after the blood extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start18 Feb 2025
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alfonso B. Alfaro, Instituto Nacional de Rehabilitacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864156
- Sponsor's protocol ID
- 03/24 AD 2025
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19
- ClinicalTrials.gov ID
- NCT06864156
- Acronym / sponsor ID
- 03/24 AD 2025
- Conditions
- Long COVID, Long COVID Syndrome
- Keywords
- anxiety, depression, fatigue, microRNAs, vitamin b12, long covid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with symptoms of depression, anxiety and fatigue after having had COVID-19
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of microRNA expression between long COVID group and control group
Time frame: immediately after the blood extraction
Change of vitamin B12 concentration between long COVID group and control group
Time frame: immediately after the blood extraction
Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue
Time frame: immediately after the blood extraction
Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue.
Time frame: immediately after the blood extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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The Study of Brave-LC LDN Treatment Trial
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Epigenetic Changes in Long COVID Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Long COVID Syndrome, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of microRNA expression between long COVID group and control group (time frame: immediately after the blood extraction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.