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

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.

Study Overview

• Status: Recruiting
• Conditions: Myalgic Encephalomyelitis
• Intervention / Treatment: Other: This is an observational cross-sectional study, there is no need for intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Nour M Shaheen, Student; Phone Number: 01060038774; Email: nourshaheen40@gmail.com
• Study Contact Backup: Name: Ahmed M Shaheen, Student; Phone Number: +20 101 099 1021; Email: ahmed.saad1704@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21523
    • Recruiting
    • Alexandria Faculty of Medicine
    • Contact: Nour Shaheen, medical student; Phone Number: 01060038774; Email: nor.saad1901@alexmed.edu.eg
    • Contact: Ahmed Shaheen, medical student; Email: ahmeds1999haheen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People above 18 years old who have experienced covid-19 or suspected COVID-19 infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Carfi 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.
• 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.
• 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.
• Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology. 2004 Jan;126(1 Suppl 1):S124-8. doi: 10.1053/j.gastro.2003.10.016.
• 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/
• 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. No abstract available.
• Coronavirus disease (COVID-19): Vaccines.
• Preda-Naumescu A, Penney K, Pearlman RL, Brodell RT, Daniel CR, Nahar VK. Nail Manifestations in COVID-19: Insight into a Systemic Viral Disease. Skin Appendage Disord. 2021 Aug 17;183(6):1-6. doi: 10.1159/000518087.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: chronic fatigue syndrome; Myalgic Encephalomyelitis; Long covid syndrome; symptoms of COVID-19
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Central Nervous System Infections; COVID-19; Myalgia; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: KRL-HI-ERC/Sep21/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

There will be no information collected that may in any way identify our patients, data will be collected via Google sheet our local collaborators will make sure all entered data is true and there is no misleading data.

The questionnaire itself is online self administered.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No