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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
632
Total 4 weeks of treatment
Total 8 weeks of treatment
Total 4 weeks of treatment
Total 8 weeks of treatment
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators
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.
Time frame: 4 weeks
Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores
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.
Time frame: 8 weeks
Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores
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.
Time frame: 4 weeks
Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators
Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline.
Time frame: 4 weeks
Inflammatory Cardiac Involvement symptom cluster: VO2max
Assessing the changes in VO2max in cardiopulmonary exercise testing.
Time frame: At baseline, 4 weeks
Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
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.
Time frame: At baseline, 4, 8, 12, and 24 weeks
Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels
Measures the change in cardiac troponin T (cTNT) levels
Time frame: At baseline, 4, 8, 12 and 24 weeks
Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE)
From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups.
Time frame: From baseline to 52 weeks
EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores
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).
Time frame: At baseline, 4, 8, 12 and 24 weeks
Pittsburgh Sleep Quality Index (PSQI) scores
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.
Time frame: At baseline 4, 8, 12, and 24 weeks
Generalized Anxiety Disorder-7 (GAD-7)
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.
Time frame: At baseline, 4, 8, 12 and 24 weeks
Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores
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.
Time frame: At baseline, 4, 8, 12 and 24 weeks
Cough symptom cluster: Visual Analogue Scale (VAS)
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.
Time frame: At baseline 4, 8 and 12 weeks
Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels
Assessing the changes in pulmonary function and FeNO levels between the experimental and control groups.
Time frame: At baseline and 8 weeks
Fatigue symptom cluster: Visual Analogue Scale (VAS)
The total score range of the VAS is from 0 to 100, with higher scores indicating more severe fatigue in the patient.
Time frame: At baseline, 4, 8, and 12 weeks
Change in proBNP Levels
Measures the change in N-terminal pro-brain natriuretic peptide (proBNP) levels, which are associated with heart failure.
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in Angiotensin II Levels
Measures the change in angiotensin II levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in Ferritin Levels
Measures the change in ferritin levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in IL-6 Levels
Measures the change in interleukin-6 (IL-6) levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in hsCRP Levels
Measures the change in high-sensitivity C-reactive protein (hsCRP) levels
Time frame: Baseline, 4, 8, 12, 24 weeks
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