Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An International Cross-Sectional Study

Myalgic Encephalomyelitis Clinical Trial

— ME  

Official title:

Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An International Cross-Sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059184
• Other study ID #: KRL-HI-ERC/Sep21/03
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2021
• Source: Alexandria University
• Contact: Nour M Shaheen, Student
• Phone: 01060038774
• Email: nourshaheen40[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The term recovery from COVID-19 caused by SARS-CoV-2 is unverified because the infection leaves many symptoms due to permanent effects on multiple organs; The primary objective of this research is to understand acute and chronic long COVID symptoms by asking questions detecting patient's experience especially symptoms lasting for several months which is known as chronic fatigue syndrome(Myalgic encephalitis). The study focuses on symptoms describing Myalgic encephalitis which may still affect COVID patients for several months after the infection along with making a big picture about rare symptoms that may the patient experienced during or after the infection. A secondary objective of this research is to focus on the long-term sequelae effects and comorbidities following COVID-19 vaccination.

Description:

After the appearance of COVID-19 caused by SARS-CoV-2, the pandemic has spread and had a profound effect on the lives and health of people around the Whole world causing around 3.97 million deaths and more than 183 million confirmed cases of the covid-19. The pandemic of COVID-19 may leave unexplainable symptoms after recovery. COVID-19 pandemic has a lot of serious symptoms, but some last for some time even after the recovery. Even some of the people who had mild symptoms during COVID-19 continue to have long terms effects after initial recovery. These people are called "long haulers" and these symptoms are called Long COVID-19. Long haulers still suffer from permanent symptoms due to multi-organ dysfunction despite normal nucleic acid tests that detect the virus. According to Dr. Anthony Fauci "patients with COVID-19 can develop a post-viral syndrome that's very strikingly similar to Myalgic encephalomyelitis/chronic fatigue syndrome" Long COVID-19 involves multiple organs and affects many systems mainly respiratory, cardiovascular, neurological, gastrointestinal, and musculoskeletal systems. The symptoms of long-covid include shortness of breath, cough, myalgias, disturbances in the sense of taste and smell, fatigue, fever, chills, and, less commonly, rhinitis and gastrointestinal symptoms cardiac abnormalities, cognitive impairment, sleep disturbances, symptoms of post-traumatic stress disorder, muscle pain, concentration problems, and headache. Those manifestations persist in one of 10 patients of the infection and last for 3-4 weeks of acute symptoms and chronic symptoms last for more than 12 weeks after the infection. According to The Centers for Disease Control and Prevention (CDC), 150 patients out of 300 who were PCR-positive for SARS-CoV-2 had permanent symptoms after three weeks after the positive test. In case the fatigue persists for six months, it is called Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS). Although the period of 6 months is no longer required for ME diagnosis according to 2011's ME international Consensus Criteria, it is still common in literature. Chronic fatigue syndrome /post-viral myalgia can not only covid-19 but also follow viral infections such as Epstein-Barr virus, Ross River virus, enteroviruses, human herpesvirus, Ebola virus, West Nile virus, Dengue virus, and parvovirus; bacteria, such as Borrelia burgdorferi, Coxiella burnetii, and Mycoplasma pneumonia; and sometimes parasites, such as Giardia lamblia, so it is expected but the problem is that it is unknown how severe it is or how it can affect the public health. Recently, there has been global concern about the effectiveness and safety of COVID-19 vaccines. According to WHO, the most common side effects that were reported about COVID-19 vaccines were fever, fatigue, headache, muscle pain, chills, diarrhea, and pain at the injection site which is more or less like some of the post covid infection symptoms so it was found that it is logical to add a section to gather information about the vaccine status, type, and timing with the symptoms. Also, some cases were reported from Canada reported weird and rare symptoms like Beau lines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Persons had a COVID-19 or suspected COVID-19 infection (still suffering or suffered symptoms) for longer than 1 week Even if your COVID-19 test result was negative, or you were not tested at all
• Persons who are 18 years of age or older General considerations according to Myalgic encephalomyelitis: International Consensus

Criteria:

• Patients should meet the full criteria for epidemiological studies. If specific subgroups or atypical ME are included in a research study, that should be clearly indicated.
• Specificity: Because critical symptoms are compulsory, it ensures the proper selection of patients. Key operational guidelines enhance clarity and specificity. Ranking the hierarchy of the most troublesome symptoms may be helpful in some studies.
• Reliability: Symptoms must not be viewed as a nominal checklist. The International Consensus Criteria focus on symptom patterns, which increase reliability. The International Symptom Scale ensures consistency in the way questions are asked and further increases the reliability of data collected in different locations. Patients should complete the International Symptom Scale prior to entering a research study.

Exclusion Criteria:

• persons other than selected in the inclusion criteria

Related Conditions & MeSH terms

• COVID-19
• Encephalomyelitis
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis

Intervention

Other:
• This is an observational cross-sectional study, there is no need for intervention
This is an observational cross-sectional study. There is no need for intervention

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

1. Carruthers BM, van de Sande MI, De Meirleir KL, Klimas NG, Broderick G, Mitchell T, Staines D, Powles AC, Speight N, Vallings R, Bateman L, Baumgarten-Austrheim B, Bell DS, Carlo-Stella N, Chia J, Darragh A, Jo D, Lewis D, Light AR, Marshall-Gradisnik S, Mena I, Mikovits JA, Miwa K, Murovska M, Pall ML, Stevens S. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med. 2011 Oct;270(4):327-38. doi: 10.1111/j.1365-2796.2011.02428.x. Epub 2011 Aug 22. Erratum in: J Intern Med. 2017 Oct;282(4):353. PMID: 21777306; PMCID: PMC3427890.

2. Carruthers BM, Sande MI van de, Meirleir KL De, Klimas NG, Broderick G, Mitchell T, et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med [Internet]. 2011 Oct 1 [cited 2021 Sep 10];270(4):327-38. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2796.2011.02428.x

4. WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data [Internet]. [cited 2021 Sep 10]. Available from: https://covid19.who.int/

9. Preda-Naumescu, A., Penney, K., Pearlman, R.L., Brodell, R.T., Daniel, C.R., Nahar, V.K., 2021. Nail Manifestations in COVID-19: Insight into a Systemic Viral Disease. Skin Appendage Disorders 1-6.. doi:10.1159/000518087

Carfì A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603. — View Citation

Coronavirus disease (COVID-19): Vaccines.

Komaroff AL, Bateman L. Will COVID-19 Lead to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? Front Med (Lausanne). 2021 Jan 18;7:606824. doi: 10.3389/fmed.2020.606824. eCollection 2020. — View Citation

Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology. 2004 Jan;126(1 Suppl 1):S124-8. Review. — View Citation

Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, Gibbs KW, Erickson HL, Steingrub JS, Smithline HA, Gong MN, Aboodi MS, Exline MC, Henning DJ, Wilson JG, Khan A, Qadir N, Brown SM, Peltan ID, Rice TW, Hager DN, Ginde AA, Stubblefield WB, Patel MM, Self WH, Feldstein LR; IVY Network Investigators; CDC COVID-19 Response Team; IVY Network Investigators . Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Jul 31;69(30):993-998. doi: 10.15585/mmwr.mm6930e1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing and understanding acute and chronic long COVID symptoms based on a questionnaire asking different questions on testing, diagnosis, and treatments.	List of relevant morbidities, testing, diagnosis, and treatments assessed as present/not present by medical interview (e.g. respiratory, cardiac, neurological, psychiatric diseases by interview and medical records)	once through study completion, an average of one year
Secondary	Assessing the long-term sequelae effects( Myalgic Encephalitis) and other comorbidities following COVID-19 vaccination.	List of relevant symptoms or signs assessed as present/not present by medical interview (e.g. neurological impairment categories, three immune/gastro-intestinal/genitourinary impairment categories, and at least one symptom from energy metabolism/transport impairments by interview and medical records); The patient will meet the criteria for post-exertional neuroimmune exhaustion, at least one symptom from three neurological impairment categories, at least one symptom from three immune/gastro-intestinal/genitourinary impairment categories, and at least one symptom from energy metabolism/transport impairments according to the Myalgic Encephalitis international consensus criteria	once through study completion, an average of one year

External Links

•   Preda-Naumescu, A., Penney, K., Pearlman, R.L., Brodell, R.T., Daniel, C.R., Nahar, V.K., 2021. Nail Manifestations in COVID-19: Insight into a Systemic Viral Disease. Skin Appendage Disorders 1-6.. doi:10.1159/000518087