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

NCT05059184 | Completed

• 1 other identifier: KRL-HI-ERC/Sep21/03
• Study Type: observational
• Target: 2,450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myalgic Encephalomyelitis

Keywords

Long covid syndrome; Myalgic Encephalomyelitis; chronic fatigue syndrome; symptoms of COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessing the long-term sequelae effects( Myalgic Encephalitis) and other comorbidities following COVID-19 vaccination.

  once through study completion, an average of one year

Interventions

This is an observational cross-sectional study, there is no need for intervention OTHER

This is an observational cross-sectional study. There is no need for intervention

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21523, Egypt

Location

Related Publications (2)

• Shaheen N, Shaheen A. Long-term sequelae of COVID-19 (myalgic encephalomyelitis): An international cross-sectional study. Medicine (Baltimore). 2022 Nov 11;101(45):e31819. doi: 10.1097/MD.0000000000031819.

  PMID: 36397426 RESULT

• Shaheen A, Shaheen N; Long COVID Collaboration Study Group in the LMICs; Shoib S, Saeed F, Buhari M, Bharmauria V, Flouty O. Deep learning analysis of long COVID and vaccine impact in low- and middle-income countries (LMICs): development of a risk calculator in a multicentric study. Front Public Health. 2025 Jun 26;13:1416273. doi: 10.3389/fpubh.2025.1416273. eCollection 2025.

  PMID: 40642241 DERIVED

Related Links

• Deep learning analysis of long COVID and vaccine impact in low- and middle-income countries (LMICs): development of a risk calculator in a multicentric study
• Main results paper

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Methods

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Shaheen

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Public Dataset, Open Source Code

Locations

EG (1)