I did a few quick Googles and I'm not sure whether this study has started recruiting yet; I'm not fully confident that it ever will. From: Dr. Marc-Alexander Fluks Sourch: Clinical Trials U.S. National Library of Medicine Date: September 28, 2021 URL: https://clinicaltrials.gov/ct2/show/NCT05059184 Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An international cross-sectional study (ME) ----------------------------------------------------------- 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. 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 Design Study Type: Observational Estimated Enrollment: 20000 participants Observational Model: Other Time Perspective: Cross-Sectional Official Title: Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An International Cross-Sectional Study Actual Study Start Date: September 1, 2021 Estimated Primary Completion Date: July 1, 2022 Estimated Study Completion Date: September 1, 2022 (...) Contacts and Locations Contacts Contact: Nour M Shaheen, Student 01060038774 nourshaheen40@gmail.com Contact: Ahmed M Shaheen, Student +20 101 099 1021 ahmed.saad1704@alexmed.edu.eg Locations Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt, 21523 Study Documents Documents provided by Alexandria University: Study Protocol, September 1, 2021, https://clinicaltrials.gov/ProvidedDocs/84/NCT05059184/Prot_000.pdf -------- (c) 2021 U.S. National Library of Medicine
i [think i foggedly] get that they are just adding v stuff to the trial and i wouldn't question the reasons too much for observational trial but i'd still like to know what they are referring to anyway: > ecently, there has been global concern about the effectiveness and safety of COVID-19 vaccines. According to WHO, the most what concern by who? at pwme levels or the 1/100k normals levels? > common side effects that were reported about COVID-19 vaccines were fever, fatigue, headache, muscle pain, chills, diarrhea, and pain at the injection site how bad and long? > 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.
Merged thread Long-term sequelae of COVID-19 (myalgic encephalomyelitis): An international cross-sectional study 2022 Shaheen and Shaheen Abstract Background: As a result of prolonged effects on multiple organs, recovery from COVID-19 caused by SARS-CoV-2 cannot be verified. This study seeks to understand chronic and acute long-term symptoms of COVID-19 lasting from a few weeks after diagnosis. The study also aims to gain insight into prevalence of chronic fatigue syndrome/myalgic encephalomyelitis, a potentially comorbid condition for several months after the infection, in addition to taking a broad perspective on rare symptoms that may have developed during or after the infection. Study design: Cross-sectional questionnaire\descriptive study. Methods: The questionnaire was developed to assess the long-term effects of the global pandemic of COVID-19 using DePaul Symptom Questionnaire-2. The DePaul Symptom Questionnaire, Patient Health Questionnaire, and other symptoms that have been introduced by literature review. Discussion: A large cohort of people from all over the world will be examined to understand the differential effects of people who have experienced COVID-19, as well as the potential occurrence of ME. In total, 20,000 COVID patients are expected to be included in the study by Sep 1, 2022. Patients who have experienced COVID-19 will be asked about their persistent symptoms from 1 week up to more than 6 months after catching or recovery from the infection. Open access, https://journals.lww.com/md-journal...g_term_sequelae_of_COVID_19__myalgic.110.aspx
This protocol does not make sense. The authors say that the study ran from September 2021 to September 2022, but they are only publishing the protocol now. Yet, they write: “The study will be conducted in centers or hospitals worldwide after getting the Institutional Review Board worldwide by the lead local investigator.” If the study was completed in September 2022, and given that the manuscript was sent to the journal on October 25th, ethical approvals for all the centers should already have been obtained. Yet only the following approvals are listed, without the relevant approval numbers from each ethics board: “Ethical approval was received from the Ethics committee of NewGiza university in November 2021(Approval No. N-14-2021) in Egypt, KRL Hospital Islamabad in Pakistan, University of Tobruk (UOT) in Libya, University of Aleppo in Syria and Hospital Riyadh Al-Jariri for fevers and treatment center for corona cases in Yemen.” Perhaps more puzzling is that only two investigators authored the paper while they mention that the study is being ran by 200 researchers in 28 countries: “This large-scale, international cross-sectional study is being conducted by ICRAA Team with collaboration with 200 researchers in 28 countries (India, Egypt, Pakistan, Brazil, Nigeria, Bangladesh, Algeria, UK, Perú, Lithuania, UAE, Jordan, Afghanistan, Yemen, Tunisia, Sudan, Turkey, Syria, Iraq, Kosovo, Morocco, Bahrain, Ecuador, Iran, United States, Palestine, Japan) around the world (Table 1).”
He’s a medical student who is probably very busy studying. I wonder was it a project for the course? Though they usually need to be finished more quickly. Anyway a very ambitious project for a student to take on without funding, hopefully there will be something of value in it.