drugset / Trial / NCT06597682

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

NCT06597682

Not yet recruiting 632 enrolled Huashan Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-03
Primary completion
2027-07
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule
Subject Formoterol Other / unclassified
Subject Prednisone Other / unclassified
Background Coenzyme Q10 Other / unclassified Oral
Background Montelukast Other / unclassified Oral
Background Vitamin C Other / unclassified Oral

Indications