Trial · NCT06597682

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

NCT06597682, Not applicable, Not yet recruiting, Huashan Hospital

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction. Trials, record NCT06597682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06597682

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
NCT number: NCT06597682
Status: Not yet recruiting
Phases: Not applicable
Enrollment: 632 participants, estimated
Lead sponsor: Huashan Hospital
Conditions: Post-acute Sequelae of SARS-COV-2 Infection
Interventions: Prednisone, Budesonide/Formoterol, Vitamin C combined with Coenzyme Q10 oral treatment, Montelukast tablets oral treatment
First posted: 2024-09-19
Last updated: 2025-03-06

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators	4 weeks	Assessing the difference in changes in cardiac magnetic resonance (CMR) indicators \[left ventricular ejection fraction, late gadolinium enhancement (LGE), and T1 and T2 mapping values (in milliseconds)\] from baseline between the experimental and control groups.
Primary	Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores	8 weeks	Assessing the difference in changes in the Leicester Cough Questionnaire (LCQ) scale scores from baseline. The total score range of the LCQ is from 3 to 21 points, with higher scores indicating a lesser impact of cough on the patient's life.
Primary	Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores	4 weeks	Assessing the difference in changes in the Fatigue Severity Scale (FSS) scale scores from baseline. The total score range of the FSS is from 9 to 63 points, with higher scores indicating a greater severity of fatigue.
Secondary	Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators	4 weeks	Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline.
Secondary	Inflammatory Cardiac Involvement symptom cluster: VO2max	At baseline, 4 weeks	Assessing the changes in VO2max in cardiopulmonary exercise testing.
Secondary	Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores	At baseline, 4, 8, 12, and 24 weeks	Assessing the changes in the KCCQ scores between the experimental and control groups. The total score range of the KCCQ is from 0 to 100, with lower scores indicating poorer quality of life for heart failure patients.
Secondary	Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels	At baseline, 4, 8, 12 and 24 weeks	Measures the change in cardiac troponin T (cTNT) levels
Secondary	Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE)	From baseline to 52 weeks	From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups.
Secondary	EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores	At baseline, 4, 8, 12 and 24 weeks	Assessing the changes in the EQ-5D-5L questionnaire scores between the experimental and control groups. The EQ-5D-5L is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) provides a descriptive profile that can be used to generate a health state profile. Each health state can be assigned a summary index score. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Secondary	Pittsburgh Sleep Quality Index (PSQI) scores	At baseline 4, 8, 12, and 24 weeks	Assessing the changes in the PSQI scores between the experimental and control groups. The total score range of the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06597682

GET https://conductscience.org/api/trials/v1/NCT06597682/registered

API reference For AI assistants