Status:
ACTIVE_NOT_RECRUITING
Skeletal Muscle in PASC and ME/CFS Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Patient-Led Research Collaborative Long COVID
Conditions:
LONG-COVID
Post-acute Sequelae of COVID-19
Eligibility:
All Genders
18-65 years
Brief Summary
Rationale: A common feature in patients with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are skeletal muscle-related symptoms, su...
Detailed Description
1. INTRODUCTION AND RATIONALE Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) are severely debilitating diseases mainly characterized...
Eligibility Criteria
Inclusion
- Inclusion criteria
- In order to be eligible to participate in this study, a subject with PASC must meet all of the following criteria:
- Non-hospitalized individuals with prior confirmed diagnosis of severe acute respiratory coronavirus 2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing
- Individuals with diagnosed PASC by a post-covid physician
- \>3 months of symptoms
- Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician
- No symptoms present before confirmed diagnosis of severe acute respiratory coronavirus 2
- Aged between 18-65 years
- In order to be eligible to participate in this study, a subject with ME/CFS must meet all of the following criteria:
- Fulfill the Canadian Consensus Criteria (CCC)
- Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician
- \>3 months of symptoms
- Aged between 18-65 years
- Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing
- For the healthy controls:
- Aged between 18-65 years
- Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing without admission
- Exclusion criteria
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of asthma, stroke, chronic obstructive pulmonary disease, congestive heart failure, heart surgery, or congenital heart diseases
- Severe illness (e.g., active malignancy, CHD, uncontrolled diabetes)
- Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 receptor agonists or immune modulatory drugs in the last three months.
- Severe psychiatric or mood disorders
- Insulin pump therapy
- Symptomatic autonomic or distal neuropathy
- BMI \>35 due to adiposity, since this is known to cause difficulties in obtaining muscle biopsies.
- Pregnancy
- Recent acute myocardial infarction (\<6 months)
- Uncontrolled arrhythmia/severe conduction disorder (atrial fibrillation or second/third degree AV block) causing hemodynamic compromise
- Implantable pacemaker or other cardiac device with complete ventricular pacing
- Uncontrolled heart failure with hemodynamic compromise
- Uncontrolled hypertension (Systolic Blood Pressure \>150 mmHg and Diastolic Blood Pressure \> 100 mmHg on repeated measurements)
- Active infection, anaemia, severe renal dysfunction (estimated Glomerular filtration rate \<30 ml/min/1,73m2) likely to significantly impact on exercise performance
- Chronic illness (including orthopaedic, endocrinological, haematological, malignant, gastrointestinal, neurological, muscle or inflammatory disorders) likely to significantly impact on exercise performance
- \> 6 alcohol units per day or \>14 alcohol units per week
- Use of anticoagulants or anti platelet therapy
- For the healthy controls:
- ● Individuals hospitalized in the last 6 months (i.e. after SARS-CoV-2 infection).
Exclusion
Key Trial Info
Start Date :
January 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05225688
Start Date
January 3 2022
End Date
December 1 2025
Last Update
August 6 2024
Active Locations (1)
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1
Amsterdam university medical centre AMC
Amsterdam, North Holland, Netherlands, 1105AZ