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Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction

ConditionPost-acute Sequelae of SARS-COV-2 Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Inflammatory Cardiac Involvement Symptom Cluster

1) Age: 18-75 years old;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone

    Drug

    Total 4 weeks of treatment

  • 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

Treatment groups

632 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Inflammatory Cardiac Involvement symptom cluster - immunomodulatory interventionExperimental treatment 2 interventions
Group B: Inflammatory Cardiac Involvement symptom clusterActive comparator 1 intervention
Group C: Cough symptom cluster - immunomodulatory interventionExperimental treatment 2 interventions
Group D: Cough symptom clusterActive comparator 1 intervention
Group E: Fatigue symptom cluster - immunomodulatory interventionExperimental treatment 2 interventions
Group F: Fatigue symptom clusterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

Inflammatory Cardiac Involvement symptom cluster: VO2max

Assessing the changes in VO2max in cardiopulmonary exercise testing.

Time frame
At baseline, 4 weeks
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: