Post-acute Sequelae of SARS-COV-2 Infection
Conditions
Keywords
Post-acute Sequelae of SARS-COV-2 Infection, Long COVID, Immunomodulatory Interventions
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 divided into three symptom clusters: Inflammatory Cardiac involvement symptoms cluster, cough symptoms cluster and fatigue symptoms cluster. Each symptom cluster is randomly divided into an experimental group and a control group, Patients who do not accept treatment can be included in the observational cohort. Subjects in the experimental group receive immunomodulatory interventions plus conventional treatment, while subjects in the control group receive conventional treatment only. Subjects in each symptom cluster undergo clinical medical record data collection, laboratory tests, and imaging examinations at specified time points, as well as records of adverse events.
Interventions
DRUGPrednisone
Total 4 weeks of treatment
DRUGBudesonide/Formoterol
Total 8 weeks of treatment
DRUGVitamin C combined with Coenzyme Q10 oral treatment
Total 4 weeks of treatment
DRUGMontelukast tablets oral treatment
Total 8 weeks of treatment
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 Inclusion Criteria: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators | 4 weeks | Assessing the difference in changes in cardiac magnetic resonance (CMR) indicators \[left ventricular ejection fraction, late gadolinium enhancement (LGE), and T1 and T2 mapping values (in milliseconds)\] from baseline between the experimental and control groups. |
| Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores | 8 weeks | Assessing the difference in changes in the Leicester Cough Questionnaire (LCQ) scale scores from baseline. The total score range of the LCQ is from 3 to 21 points, with higher scores indicating a lesser impact of cough on the patient's life. |
| Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores | 4 weeks | Assessing the difference in changes in the Fatigue Severity Scale (FSS) scale scores from baseline. The total score range of the FSS is from 9 to 63 points, with higher scores indicating a greater severity of fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels | At baseline, 4, 8, 12 and 24 weeks | Measures the change in cardiac troponin T (cTNT) levels |
| Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE) | From baseline to 52 weeks | From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups. |
| EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the EQ-5D-5L questionnaire scores between the experimental and control groups. The EQ-5D-5L is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) provides a descriptive profile that can be used to generate a health state profile. Each health state can be assigned a summary index score. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). |
| Pittsburgh Sleep Quality Index (PSQI) scores | At baseline 4, 8, 12, and 24 weeks | Assessing the changes in the PSQI scores between the experimental and control groups. The total score range of the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality. |
| Generalized Anxiety Disorder-7 (GAD-7) | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the GAD-7 scores between the experimental and control groups. The total score range of the GAD-7 is from 0 to 21, with higher scores indicating more severe anxiety. |
| Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the PHQ-9 cores between the experimental and control groups. The total score range of the PHQ-9 is from 0 to 27, with higher scores indicating more severe depression. |
| Cough symptom cluster: Visual Analogue Scale (VAS) | At baseline 4, 8 and 12 weeks | Assessing the change in the severity of cough as measured by the VAS between the experimental and control groups . The total score range of the VAS is from 0 to 100, with higher scores indicating more severe coughing in the patient. |
| Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators | 4 weeks | Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline. |
| Fatigue symptom cluster: Visual Analogue Scale (VAS) | At baseline, 4, 8, and 12 weeks | The total score range of the VAS is from 0 to 100, with higher scores indicating more severe fatigue in the patient. |
| Change in proBNP Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in N-terminal pro-brain natriuretic peptide (proBNP) levels, which are associated with heart failure. |
| Change in Angiotensin II Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in angiotensin II levels |
| Change in Ferritin Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in ferritin levels |
| Change in IL-6 Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in interleukin-6 (IL-6) levels |
| Change in hsCRP Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in high-sensitivity C-reactive protein (hsCRP) levels |
| Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels | At baseline and 8 weeks | Assessing the changes in pulmonary function and FeNO levels between the experimental and control groups. |
| Inflammatory Cardiac Involvement symptom cluster: VO2max | At baseline, 4 weeks | Assessing the changes in VO2max in cardiopulmonary exercise testing. |
| Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores | At baseline, 4, 8, 12, and 24 weeks | Assessing the changes in the KCCQ scores between the experimental and control groups. The total score range of the KCCQ is from 0 to 100, with lower scores indicating poorer quality of life for heart failure patients. |
Countries
China
Outcome results
None listed