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NCT05166876: CCBCRISIS04

Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19

Terminated Phase 2 Results posted Last updated 7 November 2023
What this trial tests

Phase 2 trial testing Brequinar Sodium in COVID-19 in 26 participants. Terminated before completion.

Timeline
1 February 2022
Primary endpoint
4 June 2022
4 June 2022

Quick facts

Lead sponsorClear Creek Bio, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment26
Start date1 February 2022
Primary completion4 June 2022
Estimated completion4 June 2022
Sites7 locations across India

Drugs / interventions tested

Conditions studied

Sponsor

Clear Creek Bio, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with COVID-19. 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.

Safety and Tolerability of the Brequinar-dipyridamole Combination in COVID-19 Subjects Primary · Day 29

There were no subjects who experienced grade 3 and 4 toxicities and serious adverse events (SAEs) considered by the investigator to be related to the combination, brequinar alone or placebo alone. therefore frequencies of these events could not be compared.

GroupValue95% CI
Brequinar Monotherapy0
Placebo0
Brequinar-Dipyridamole Combination0

Adverse events — posted to ClinicalTrials.gov

Time frame: 29 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brequinar Monotherapy
Serious: 0/7 (0%)
Deaths: 0/7
Placebo
Serious: 0/6 (0%)
Deaths: 0/6
Brequinar-Dipyridamole Combination
Serious: 0/13 (0%)
Deaths: 0/13
Other adverse events (10 terms — click to expand)

ReactionSystemBrequinar MonotherapyPlaceboBrequinar-Dipyridamole Com…
VomitingGastrointestinal disorders
HeadacheNervous system disorders
Abdominal pain upperGastrointestinal disorders
EosinophiliaBlood and lymphatic system disorders
FatigueGeneral disorders
AstheniaGastrointestinal disorders
PyrexiaGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
RashSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT05166876 adverse events section.

Sponsor's own description

A Phase 2 multi-center, assessor-blind, randomized study to assess the safety, tolerability, and antiviral activity of brequinar in combination with dipyridamole.

Publications & conference data

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

  1. Nucleotide metabolism: a pan-cancer metabolic dependency.
    Mullen NJ, Singh PK. · · 2023 · cited 308× · PMID 36973407 · DOI 10.1038/s41568-023-00557-7
  2. DHODH-mediated mitochondrial redox homeostasis: a novel ferroptosis regulator and promising therapeutic target.
    Cao J, Chen X, Chen L, Lu Y, et al · · 2025 · cited 23× · PMID 40716151 · DOI 10.1016/j.redox.2025.103788
  3. ENT1 blockade by CNX-774 overcomes resistance to DHODH inhibition in pancreatic cancer.
    Mullen NJ, Thakur R, Shukla SK, Chaika NV, et al · · 2023 · cited 22× · PMID 36341997 · DOI 10.1016/j.canlet.2022.215981
  4. The interplay between inflammation and thrombosis in COVID-19: Mechanisms, therapeutic strategies, and challenges.
    Ma L, Willey J. · · 2022 · cited 17× · PMID 38620713 · DOI 10.1016/j.tru.2022.100117
  5. Multi-omics for COVID-19: driving development of therapeutics and vaccines.
    Guo M, Xiong M, Peng J, Guan T, et al · · 2023 · cited 14× · PMID 37936830 · DOI 10.1093/nsr/nwad161
  6. Brequinar and dipyridamole in combination exhibits synergistic antiviral activity against SARS-CoV-2 in vitro: Rationale for a host-acting antiviral treatment strategy for COVID-19.
    Demarest JF, Kienle M, Boytz R, Ayres M, et al · · 2022 · cited 11× · PMID 36041646 · DOI 10.1016/j.antiviral.2022.105403
  7. Broad-acting antivirals: the pursuit of pan-viral therapeutics in the era of pandemics.
    Bayurova E, Kostyushev D, Tikhonov A, Chulanov V, et al · · 2026 · PMID 41870078 · DOI 10.1128/jvi.00077-26
  8. Brequinar and Dipyridamole in Combination Exhibits Synergistic Antiviral Activity Against SARS-CoV-2 <i>in vitro</i> : Rationale for a host-acting antiviral treatment strategy for COVID-19
    Demarest JF, Kienle M, Boytz R, Ayres M, et al · · 2022 · DOI 10.1101/2022.03.30.486499

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Other recruiting trials for COVID-19

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