Trial · NCT06974084
A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID
NCT06974084, Phase 2, Phase 3, Not yet recruiting, HealthBio, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID. Trials, record NCT06974084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06974084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID
- NCT number
- NCT06974084
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 252 participants, estimated
- Lead sponsor
- HealthBio, Inc.
- Conditions
- Long COVID
- Interventions
- Maraviroc (MVC), Atorvastatin, 10mg, 20mg, 40mg, Placebo, Maraviroc, Placebo, Atorvastatin
- First posted
- 2025-05-15
- Last updated
- 2026-06-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fatigue | PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12. | Fatigue will be measured via PROMIS Fatigue v1.0. The PROMIS Fatigue 10a assesses fatigue severity in the previous week. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The instrument translates the total raw score into a T-score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population (SD=10). |
| Secondary | Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31) | Scores will be determined at Visit 1 (Day 1) and EOT (week -12) | To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on dysautonomia symptoms 12 weeks after treatment initiation in individuals with Long COVID. |
| Secondary | Improved Cognitive Function, measured by the PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a | Difference in T-score measured at Visit 1 (Day 1) and EOT (week-12) | The PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS Cognitive Function item bank that assesses patient-perceived cognitive deficits. Each item has five response options ranging in value from one to five. The total raw score for a short form with all questions answered, is the sum of the values of the response to each question and ranges between 6 and 30. The raw score is translated in a T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. |
| Secondary | To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 12. | LHI will be measured at Screening and EOT (week-12) | To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on the LHI 12 weeks after treatment initiation in individuals with Long COVID. |
| Secondary | To assess the proportion of participants with a PROMIS Fatigue T-score improvement from baseline ≥5 points 12 weeks after treatment initiation. | From baseline Visit 1 (Day-1) and EOT (week-12) | In subjects with Long COVID complying with the key protocol criteria (evaluable participants) who received 12 weeks of study treatment: ● Change in the proportion of subjects who improve their PROMIS T-score from baseline to week 12 in maraviroc/atorvastatin and placebo groups. |
| Secondary | To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19 | Adverse event collection will be done during every Visit (Day-1, Week-4, Week-8, Week-12, Week-16 (EOT) and EOS (28-42 Days after last dose) | Participants report data will be compiled as follows: Percentage of participants reporting AEs from Dose 1 to 28 days after the last dose. Percentage of participants reporting SAEs from Dose 1 to 28 days after the last dose. Percentage of participants reporting AEs leading to discontinuation. Percentage of participants reporting SAEs leading to discontinuation. |
| Secondary | To evaluate IncellKINE Biomarkers | Screening and EOT (week-12) | To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on IncellKINE biomarker levels in individuals with Long COVID 12 weeks after treatment initiation. |
Source ClinicalTrials.gov
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.
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/NCT06974084
GET https://conductscience.org/api/trials/v1/NCT06974084/registered