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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention | Experimental |
| |
| Inflammatory Cardiac Involvement symptom cluster | Active Comparator |
| |
| Cough symptom cluster - immunomodulatory intervention | Experimental |
| |
| Cough symptom cluster | Active Comparator |
| |
| Fatigue symptom cluster - immunomodulatory intervention | Experimental |
| |
| Fatigue symptom cluster | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Total 4 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Inflammatory Cardiac Involvement symptom cluster: VO2max |
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Inclusion Criteria:
Symptom Cluster Inclusion Criteria:
Exclusion Criteria:
Symptom Cluster Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| Budesonide/Formoterol | Drug | Total 8 weeks of treatment |
|
| Vitamin C combined with Coenzyme Q10 oral treatment | Drug | Total 4 weeks of treatment |
|
| Montelukast tablets oral treatment | Drug | Total 8 weeks of treatment |
|
Assessing the changes in VO2max in cardiopulmonary exercise testing. |
| 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. | 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 | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 4, 8, 12, 24 weeks |
| Change in Angiotensin II Levels | Measures the change in angiotensin II levels | Baseline, 4, 8, 12, 24 weeks |
| Change in Ferritin Levels | Measures the change in ferritin levels | Baseline, 4, 8, 12, 24 weeks |
| Change in IL-6 Levels | Measures the change in interleukin-6 (IL-6) levels | Baseline, 4, 8, 12, 24 weeks |
| Change in hsCRP Levels | Measures the change in high-sensitivity C-reactive protein (hsCRP) levels | Baseline, 4, 8, 12, 24 weeks |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| C093875 | montelukast |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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