Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
1. Age ≥18 years;
2. Post-infection with SARS-CoV-2 for more than 3 months and meets the World Health Organization (WHO) definition of Long COVID;
3. Symptom criteria: Meet the inclusion and
Disqualifiers
4. Fertile female subjects are not breastfeeding or pregnant at the time of enrollment (negative urine pregnancy test);
5. Willing and able to provide informed consent, complete surveys, clinical assessments, and all necessary follow-up visits;
Inflammatory Cardiac Involvement Symptom Cluster
1) Age: 18-75 years old;
Trial design
Treatments tested in this trial
- Prednisone
- Budesonide/Formoterol
- Vitamin C combined with Coenzyme Q10 oral treatment
- Montelukast tablets oral treatment
Treatment groups
632 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov