Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06597682
NA

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

632

Start Date

2025-03

Completion Date

2027-07

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

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

Locations (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China