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

NCT06597682 | Not Yet Recruiting

• 1 other identifier: RISE
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-acute Sequelae of SARS-COV-2 Infection

Keywords

Post-acute Sequelae of SARS-COV-2 Infection; Long COVID; Immunomodulatory Interventions

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (17)

• Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators

  4 weeks

• Inflammatory Cardiac Involvement symptom cluster: VO2max

  At baseline, 4 weeks

• Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores

  At baseline, 4, 8, 12, and 24 weeks

• Inflammatory Cardiac Involvement symptom cluster: Change in 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 52 weeks

Study Arms (6)

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

Interventions

Prednisone DRUG

Total 4 weeks of treatment

Fatigue symptom cluster - immunomodulatory intervention; Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention

Budesonide/Formoterol DRUG

Total 8 weeks of treatment

Cough symptom cluster - immunomodulatory intervention

Vitamin C combined with Coenzyme Q10 oral treatment DRUG

Total 4 weeks of treatment

Fatigue symptom cluster; Fatigue symptom cluster - immunomodulatory intervention; Inflammatory Cardiac Involvement symptom cluster; Inflammatory Cardiac Involvement symptom cluster - immunomodulatory intervention

Montelukast tablets oral treatment DRUG

Total 8 weeks of treatment

Cough symptom cluster; Cough symptom cluster - immunomodulatory intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years;
• \. Post-infection with SARS-CoV-2 for more than 3 months and meets the World Health Organization (WHO) definition of Long COVID;

You may not qualify if:

• \. Fertile female subjects are not breastfeeding or pregnant at the time of enrollment (negative urine pregnancy test);
• \. Willing and able to provide informed consent, complete surveys, clinical assessments, and all necessary follow-up visits;
• Inflammatory Cardiac Involvement Symptom Cluster
• \) Age: 18-75 years old;
• \) Presence of cardiac symptoms at the time of enrollment (e.g., Chest tightness after physical activity, chest pain, difficulty breathing, palpitations, fatigue, etc.);
• \) 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
• \) 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.;
• \) Chest X-ray or CT scan shows no abnormalities that could lead to cough or other serious lung diseases;
• \) 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Prednisone; Budesonide, Formoterol Fumarate Drug Combination; montelukast; Therapeutics

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)