NCT06597682

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

A Randomized Controlled Basket Study for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction (RISE)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 632 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Prednisone	Total 4 weeks of treatment
DRUG	Budesonide/Formoterol	Total 8 weeks of treatment
DRUG	Vitamin C combined with Coenzyme Q10 oral treatment	Total 4 weeks of treatment
DRUG	Montelukast tablets oral treatment	Total 8 weeks of treatment

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-09-19
• Last updated: 2025-03-06

Locations

1 site across 1 country: China