Post-acute Sequelae of SARS-COV-2 InfectionRISENCT06597682
Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
A study testing Prednisone, Budesonide/Formoterol and Vitamin C combined with Coenzyme Q10 oral treatment in people with Post-acute Sequelae of SARS-COV-2 Infection, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-acute Sequelae of SARS-COV-2 Infection
- What is being tested?
- Prednisone, Budesonide/Formoterol and Vitamin C combined with Coenzyme Q10 oral treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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);
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- 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 Exclusion Criteria:
- Inflammatory Cardiac Involvement Symptom Cluster
- 1) Past medical history or cardiac magnetic resonance (CMR) evidence indicating significant cardiac disease, including:
- a) Known left ventricular ejection fraction (LVEF) <40% indicating cardiac dysfunction;
- b) Congestive heart failure (New York Heart Association Class III-IV);
- c) Ongoing treatment for heart failure (including HFrEF and HFpEF);
- d) Confirmed ischemic heart disease, peripheral artery disease, and/or cerebrovascular disease;
- e) Persistent or permanent atrial fibrillation or significant arrhythmias;
- f) Congenital or clinically relevant valvular heart disease (moderate or severe);
- g) Specific cardio myopathies (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, non-compacted cardiomyopathy, etc.);
- 2) Contraindications for contrast-enhanced cardiac magnetic resonance (CMR) imaging, such as: use of implanted devices not compatible with MRI; known allergy to gadolinium-based contrast agents (CBGA);
- 3) Patients with structural heart disease or incidental arrhythmias detected on cardiac magnetic resonance imaging will be advised to consult their physicians.
- Cough Symptom Cluster
- 1) Current smoker or having quit smoking for less than 6 months;
- 2) Intolerance to pulmonary function testing and/or FeNO;
- 3) Chest CT showing acute pulmonary infection-related diseases;
- 4) Forced expiratory volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio less than 60%;
- 5) Currently taking or having used angiotensin-converting enzyme inhibitors (ACEI) within the past 3 months of screening;
- 6) Received any relevant traditional Chinese or Western medical treatment within the last month.
- Fatigue Symptom Cluster
- 1) Received any relevant traditional Chinese or Western medical treatment within the last month, taking sedatives, hypnotics, melatonin, or antidepressants;
- 2) Known previous diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome unrelated to SARS-CoV-2 infection;
- 3) Known previous autonomic dysfunction unrelated to SARS-CoV-2 infection;
- 4) Fatigue caused by metabolism-related diseases (such as hyperthyroidism or hypothyroidism, malnutrition) that developed following SARS-CoV-2 infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD, MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
About this study
Official title: A Randomized Controlled Basket Study for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction (RISE)
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.
- Being tested
- Prednisone, Budesonide/Formoterol, Vitamin C combined with Coenzyme Q10 oral treatment, Montelukast tablets oral treatment
- Keywords
- Post-acute Sequelae of SARS-COV-2 Infection, Long COVID, Immunomodulatory Interventions
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Total 4 weeks of treatment
Budesonide/FormoterolDrug
Total 8 weeks of treatment
Vitamin C combined with Coenzyme Q10 oral treatmentDrug
Total 4 weeks of treatment
Montelukast tablets oral treatmentDrug
Total 8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention | Experimental | Not described Receives: Drug: Prednisone; Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Inflammatory Cardiac Involvement symptom cluster | Active comparator | Not described Receives: Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Cough symptom cluster - immunomodulatory intervention | Experimental | Not described Receives: Drug: Budesonide/Formoterol; Drug: Montelukast tablets oral treatment |
| Cough symptom cluster | Active comparator | Not described Receives: Drug: Montelukast tablets oral treatment |
| Fatigue symptom cluster - immunomodulatory intervention | Experimental | Not described Receives: Drug: Prednisone; Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Fatigue symptom cluster | Active comparator | Not described Receives: Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (17)
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.
Measured: 4 weeks
Inflammatory Cardiac Involvement symptom cluster: VO2max
Assessing the changes in VO2max in cardiopulmonary exercise testing.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4, 8, 12, 24 weeks
Change in Angiotensin II Levels
Measures the change in angiotensin II levels
Measured: Baseline, 4, 8, 12, 24 weeks
Change in Ferritin Levels
Measures the change in ferritin levels
Measured: Baseline, 4, 8, 12, 24 weeks
Change in IL-6 Levels
Measures the change in interleukin-6 (IL-6) levels
Measured: Baseline, 4, 8, 12, 24 weeks
Change in hsCRP Levels
Measures the change in high-sensitivity C-reactive protein (hsCRP) levels
Measured: Baseline, 4, 8, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startMar 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute Sequelae of SARS-COV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597682
- Sponsor's protocol ID
- RISE
- Acronym
- RISE
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Basket Study for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction (RISE)
- ClinicalTrials.gov ID
- NCT06597682
- Acronym / sponsor ID
- RISE / RISE
- Keywords
- Post-acute Sequelae of SARS-COV-2 Infection, Long COVID, Immunomodulatory Interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention | Experimental | Drug: Prednisone, Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Inflammatory Cardiac Involvement symptom cluster | Active comparator | Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Cough symptom cluster - immunomodulatory intervention | Experimental | Drug: Budesonide/Formoterol, Drug: Montelukast tablets oral treatment |
| Cough symptom cluster | Active comparator | Drug: Montelukast tablets oral treatment |
| Fatigue symptom cluster - immunomodulatory intervention | Experimental | Drug: Prednisone, Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
| Fatigue symptom cluster | Active comparator | Drug: Vitamin C combined with Coenzyme Q10 oral treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (34 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneTotal 4 weeks of treatment | Drug | Fatigue symptom cluster - immunomodulatory intervention, Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention |
| Budesonide/FormoterolTotal 8 weeks of treatment | Drug | Cough symptom cluster - immunomodulatory intervention |
| Vitamin C combined with Coenzyme Q10 oral treatmentTotal 4 weeks of treatment | Drug | Fatigue symptom cluster, Fatigue symptom cluster - immunomodulatory intervention, Inflammatory Cardiac Involvement symptom cluster, Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention |
| Montelukast tablets oral treatmentTotal 8 weeks of treatment | Drug | Cough symptom cluster, Cough symptom cluster - immunomodulatory intervention |
Primary outcome
Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators
Time frame: 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
Time frame: 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
Time frame: 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.
17 secondary outcomes
Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators
Time frame: 4 weeks
Inflammatory Cardiac Involvement symptom cluster: VO2max
Time frame: At baseline, 4 weeks
Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
Time frame: At baseline, 4, 8, 12, and 24 weeks
Inflammatory Cardiac Involvement symptom cluster: Change in 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)
Time frame: From baseline to 52 weeks
EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores
Time frame: At baseline, 4, 8, 12 and 24 weeks
Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: At baseline 4, 8, 12, and 24 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At baseline, 4, 8, 12 and 24 weeks
Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores
Time frame: At baseline, 4, 8, 12 and 24 weeks
Cough symptom cluster: Visual Analogue Scale (VAS)
Time frame: At baseline 4, 8 and 12 weeks
Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels
Time frame: At baseline and 8 weeks
Fatigue symptom cluster: Visual Analogue Scale (VAS)
Time frame: At baseline, 4, 8, and 12 weeks
Change in proBNP Levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in Angiotensin II Levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in Ferritin Levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in IL-6 Levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Change in hsCRP Levels
Time frame: Baseline, 4, 8, 12, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huashan Hospital of Fudan University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone, Budesonide/Formoterol and Vitamin C combined with Coenzyme Q10 oral treatment in people with Post-acute Sequelae of SARS-COV-2 Infection, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.