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

NCT06597682 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2025-03-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597682 on ClinicalTrials.gov