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NCT05166876
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Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19 |
Recruiting |
Phase 2 |
Feb/01/2022 |
Jul/01/2022 |
- Alternative id - CCB-CRISIS-04
- Interventions - Drug: Brequinar Sodium|Drug: Dipyridamole 75 MG|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - RIMS - Government Medical College, Srikakulam, Andhra Pradesh, India|King George Hospital, Visakhapatnam, Andhra Pradesh, India|JIPMER Hospital, Pondicherry, Puducherry, India|Noble Hospital, Hadapsar, Pune, India|Panimalar Hospital, Chennai, Tamil Nadu, India
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 112
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Safety and tolerability of the brequinar-dipyridamole combination in COVID-19 subjects|Reduction of SARS-CoV-2 levels using qPCR through Day 29 and at days 4, 8, 12, 15, 22, and 29|Reduction in time to symptom improvement|Reduction in percentage of subjects requiring hospital admission/re-admission as an in-patient for >24 hours|Reduction in percentage of subjects requiring medical attended visits, e.g., hospitalization, emergency room visits, Urgent Care/Family Doctor visits|Reduction in percentage of subjects requiring supplemental support such as oxygen
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NCT04575038
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CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19 |
Completed |
Phase 2 |
Nov/19/2020 |
Apr/28/2021 |
- Alternative id - CCB-CRISIS-02
- Interventions - Drug: Brequinar|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Central Alabama Research, Homewood, Alabama, United States|Ark Clinical Research, Long Beach, California, United States|Doral Medical Research, Doral, Florida, United States|South Jersey Infectious Disease, Somers Point, New Jersey, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Wilmington Health, Wilmington, North Carolina, United States|Remington-Davis, Inc., Columbus, Ohio, United States|Toledo Institute of Clinical Research, Toledo, Ohio, United States|VitaLink - Gaffney, Gaffney, South Carolina, United States|Self Regional Healthcare Research Center - Self Medical Group, Greenwood, South Carolina, United States|VitaLink Research, Spartanburg, South Carolina, United States|Clinical Trials Center of Middle Tennessee, Franklin, Tennessee, United States|Centex Studies, Inc. - McAllen, McAllen, Texas, United States|Synexus Clinical Research US, Inc. - Olympus Family Medicine, Salt Lake City, Utah, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 115
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - SARS-CoV-2 viral load|Rates of AEs and SAEs including laboratory assessments|Viral shedding duration|Hospital Admission
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NCT04425252
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Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19 |
Completed |
Phase 1|Phase 2 |
Aug/19/2020 |
Jan/12/2021 |
- Alternative id - CCB-CRISIS-01
- Interventions - Drug: Brequinar|Other: Standard of Care
- Study type - Interventional
- Study results - Has Results
- Locations - Hartford Hospital, Hartford, Connecticut, United States|Baptist Medical Center, Jacksonville, Florida, United States|University of South Florida/Tampa General, Tampa, Florida, United States|University of New Mexico, Albuquerque, New Mexico, United States|Temple University, Philadelphia, Pennsylvania, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 25
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Safety/Tolerability Assessed by Rates of Grade 3 or 4 Post Randomization Adverse Events|Safety/Tolerability as Assessed by Rates of Serious Adverse Events (SAEs).|Safety/Tolerability Measured by Mortality at Day 29|Hospitalization Status|Duration of Hospitalization|NEWS2 Score
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