Dolphin
Senior Member (Voting Rights)
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
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
