Status:
NOT_YET_RECRUITING
Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
Lead Sponsor:
Huashan Hospital
Conditions:
Post-acute Sequelae of SARS-COV-2 Infection
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is a prospective, randomized controlled, basket trial. Patients diagnosed with Post-Acute Sequelae of SARS-CoV-2 Infection who meet the inclusion and exclusion criteria are recruited and di...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years;
- 2\. Post-infection with SARS-CoV-2 for more than 3 months and meets the World Health Organization (WHO) definition of Long COVID;
- 3\. Symptom criteria: Meet the inclusion and exclusion criteria for each symptom cluster;
- 4\. Fertile female subjects are not breastfeeding or pregnant at the time of enrollment (negative urine pregnancy test);
- 5\. Willing and able to provide informed consent, complete surveys, clinical assessments, and all necessary follow-up visits;
- Symptom Cluster
- Inflammatory Cardiac Involvement Symptom Cluster
- 1\) Age: 18-75 years old;
- 2\) Presence of cardiac symptoms at the time of enrollment (e.g., Chest tightness after physical activity, chest pain, difficulty breathing, palpitations, fatigue, etc.);
- 3\) CMR shows the following abnormal findings based on any of the following criteria:
- a) Native T1 increase ≥ 1130 milliseconds at 3.0 T (or an increase of 1030 milliseconds at 1.5 T) and/or;
- b) Native T2 ≥ 39.5 milliseconds at 3.0 T (or 49.5 milliseconds at 1.5 T) and/or;
- c) Presence of non-ischemic myocardial and pericardial late gadolinium enhancement and/or;
- d) Left ventricular ejection fraction ≥ 40% and ≤50%.
- Cough Symptom Cluster
- 1\) Clinical assessment of cough according to ACCP guidelines indicates no cough caused by other diseases such as COPD, asthma, chronic bronchitis, gastroesophageal reflux, bronchiectasis, etc.;
- 2\) Chest X-ray or CT scan shows no abnormalities that could lead to cough or other serious lung diseases;
- 3\) FENO ≥25 ppb, or the proportion of eosinophils in sputum cytology ≥2.5%; or the blood eosinophil count \>0.3×10⁹/L.
- Fatigue Symptom Cluster
- 1\) Fatigue Severity Scale (FSS) average score ≥ 4;
- 2\) Any inflammatory marker (CRP, ESR, PCT, ferritin, IL-6, TNFα) is above the upper limit of normal.
Exclusion
- 1\. Known SARS-CoV-2 infection within 3 months prior to the date of informed consent signature;
- 2\. Systemic fungal infection and active infections that cannot be controlled by anti-infective agents;
- 3\. Current or recent (within the last 10 weeks) use of glucocorticoids, other immunosuppressants, or biologic agents;
- 4\. Known allergy/sensitivity or any hypersensitivity reaction to the study intervention or control components;
- 5\. Known contraindications to the study intervention;
- 6\. Any persistent central nervous system disorders, psychiatric illnesses, chronic respiratory or cardiac diseases, Underlying diseases (poorly controlled diabetes, poorly controlled hypertension, peripheral edema, cataracts or glaucoma, peptic ulcer disease, femoral head necrosis, low bone density, or osteoporosis);
- 7\. For female participants: pregnant or breastfeeding at screening, or expecting to become pregnant during the study period; women of childbearing age who are unwilling to use effective contraceptive measures (defined as PEARL index \<1, such as birth control pills, intrauterine devices);
- 8\. Known alcohol, drug, or chemical abuse;
- 9\. Currently participating in another clinical trial;
- 10\. Deemed ineligible to participate in this study by the investigator's assessment.
- Symptom Cluster
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT06597682
Start Date
March 1 2025
End Date
July 1 2027
Last Update
March 6 2025
Active Locations (1)
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1
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200040