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NCT05126563: HBPCOVID02

Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome

Completed Phase 2 Results posted Last updated 26 September 2025
What this trial tests

Phase 2 trial testing HB-adMSCs (allogeneic) in Post COVID-19 Syndrome in 79 participants. Completed in 2 April 2024.

Timeline
2 February 2022
Primary endpoint
2 April 2024
2 April 2024

Quick facts

Lead sponsorHope Biosciences Research Foundation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment79
Start date2 February 2022
Primary completion2 April 2024
Estimated completion2 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hope Biosciences Research Foundation

Who can join

Adults 18 to 70, any sex, with Post COVID-19 Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

GroupValue95% CI
HB-adMSCs-2.376± 0.496
Placebo-2.430± 0.529
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).

GroupValue95% CI
HB-adMSCs-1.908± 0.462
Placebo-1.736± 0.493
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).

GroupValue95% CI
HB-adMSCs-0.755± 0.348
Placebo-1.154± 0.371
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

GroupValue95% CI
HB-adMSCs-2.005± 0.486
Placebo-2.547± 0.518
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).

GroupValue95% CI
HB-adMSCs-0.509± 0.314
Placebo-0.462± 0.335
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).

GroupValue95% CI
HB-adMSCs-0.623± 0.241
Placebo-0.463± 0.258
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) Primary · Baseline to Week 26

Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-1.010± 0.406
Placebo-0.772± 0.428
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-1.214± 0.438
Placebo-1.439± 0.468
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-2.010± 0.463
Placebo-2.018± 0.494
EOS (Week 26)
GroupValue95% CI
HB-adMSCs-2.330± 0.490
Placebo-2.492± 0.522
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) Primary · Baseline to Week 26

Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-1.134± 0.352
Placebo-0.944± 0.371
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-1.425± 0.377
Placebo-0.837± 0.402
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-2.281± 0.419
Placebo-1.532± 0.446
End of Study (Week 26)
GroupValue95% CI
HB-adMSCs-1.827± 0.467
Placebo-1.818± 0.497
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) Primary · Baseline to Week 26

Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-0.362± 0.400
Placebo-0.548± 0.422
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-0.504± 0.388
Placebo-0.648± 0.414
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-0.696± 0.385
Placebo-0.870± 0.411
End Of Study (Week 26)
GroupValue95% CI
HB-adMSCs-0.741± 0.346
Placebo-1.181± 0.369
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-1.331± 0.340
Placebo-0.730± 0.357
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-1.845± 0.462
Placebo-1.813± 0.492
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-2.028± 0.466
Placebo-2.095± 0.497
End of Study (Week 26)
GroupValue95% CI
HB-adMSCs-2.016± 0.479
Placebo-2.551± 0.510
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-0.450± 0.234
Placebo0.235± 0.247
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-0.372± 0.325
Placebo0.523± 0.346
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-0.654± 0.339
Placebo-0.365± 0.362
End of Study (Week 26)
GroupValue95% CI
HB-adMSCs-0.569± 0.318
Placebo-0.408± 0.339
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) Primary · Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).

Infusion 2 (Week 2)
GroupValue95% CI
HB-adMSCs-0.336± 0.273
Placebo0.617± 0.288
Infusion 3 (Week 6)
GroupValue95% CI
HB-adMSCs-0.112± 0.264
Placebo-0.013± 0.281
Infusion 4 (Week 10)
GroupValue95% CI
HB-adMSCs-0.678± 0.242
Placebo-0.196± 0.258
End Of Study (Week 26)
GroupValue95% CI
HB-adMSCs-0.653± 0.241
Placebo-0.438± 0.256

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 (Infusion 1) through Week 26 (End of Study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HB-adMSCs
Serious: 0/39 (0%)
Deaths: 0/39
Placebo
Serious: 0/40 (0%)
Deaths: 0/40
Other adverse events (91 terms — click to expand)

ReactionSystemHB-adMSCsPlacebo
FatigueGeneral disorders
HeadacheNervous system disorders
Influenza like illnessGeneral disorders
NauseaGastrointestinal disorders
ChillsGeneral disorders
PyrexiaGeneral disorders
DizzinessNervous system disorders
COVID-19Infections and infestations
Back painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
PainGeneral disorders
MalaiseGeneral disorders
Brain FogNervous system disorders
Cognitive DisorderNervous system disorders
MigraineNervous system disorders
SomnolenceNervous system disorders
SinusitisInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
AstheniaGeneral disorders
Feeling abnormalGeneral disorders
Feeling hotGeneral disorders
Depressed level of consciousnessNervous system disorders
AgeusiaNervous system disorders
AnosmiaNervous system disorders
Coordination abnormalNervous system disorders
DysgeusiaNervous system disorders
LethargyNervous system disorders
Multiple SclerosisNervous system disorders
Muscle contractions involuntarilyNervous system disorders
Neuropathy peripheralNervous system disorders
ParesthesiaNervous system disorders
ParkinsonismNervous system disorders
TremorNervous system disorders
Urinary tract infectionInfections and infestations
CellulitisInfections and infestations
Clostridium difficile colitisInfections and infestations
EpididymitisInfections and infestations
Genital herpes simplexInfections and infestations
Genital infection maleInfections and infestations

Data from ClinicalTrials.gov NCT05126563 adverse events section.

Sponsor's own description

This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical trials on the pharmacological treatment of long COVID: A systematic review.
    Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289
  2. Immunomodulation of Mesenchymal Stem Cells in Acute Lung Injury: From Preclinical Animal Models to Treatment of Severe COVID-19.
    Li JP, Wu KH, Chao WR, Lee YJ, et al · · 2022 · cited 16× · PMID 35897770 · DOI 10.3390/ijms23158196
  3. Critical roles of cytokine storm and bacterial infection in patients with COVID-19: therapeutic potential of mesenchymal stem cells.
    Arjmand B, Alavi-Moghadam S, Sarvari M, Rezaei-Tavirani M, et al · · 2023 · cited 9× · PMID 36600055 · DOI 10.1007/s10787-022-01132-6
  4. Mechanisms of Potential Therapeutic Utilization of Mesenchymal Stem Cells in COVID-19 Treatment.
    Fang Y, Lao P, Tang L, Chen J, et al · · 2023 · cited 8× · PMID 37395459 · DOI 10.1177/09636897231184611
  5. Immune-Cell-Based Therapy for COVID-19: Current Status.
    Wang Y, Liang Q, Chen F, Zheng J, et al · · 2023 · cited 3× · PMID 38005826 · DOI 10.3390/v15112148
  6. Therapeutic challenges in central nervous system viral infections: advancing mesenchymal stem cell-based strategies for treating neuroinflammation and promoting tissue repair.
    Carbone-Schellman J, Fontecilla-Escobar J, Sales-Salinas N, Chaparro-Pico WF, et al · · 2025 · cited 1× · PMID 41235241 · DOI 10.3389/fimmu.2025.1677433
  7. Materiobiology-guided regulation of mesenchymal stromal cell fate for aging-related diseases: From basic parameter design to clinical application.
    Feng Y, Qiu Y, Zhang S, Dai K, et al · · 2026 · PMID 41799951 · DOI 10.1016/j.bioactmat.2026.02.034

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05126563.

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