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NCT04488081
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I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
Recruiting |
Phase 2 |
Jul/31/2020 |
Nov/01/2022 |
- Alternative id - I-SPY-COVID
- Interventions - Drug: Remdesivir|Drug: Pulmozyme|Drug: IC14|Drug: Celecoxib Famotidine|Drug: Narsoplimab|Drug: Aviptadil Acetate|Drug: Cyclosporine
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Alabama at Birmingham, Birmingham, Alabama, United States|UC Davis Medical Center, Davis, California, United States|Long Beach Memorial Medical Center, Long Beach, California, United States|University of Southern California, Los Angeles, California, United States|Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States|University of California San Francisco (UCSF), San Francisco, California, United States|University of Colorado, Aurora, Colorado, United States|Yale Cancer Center, New Haven, Connecticut, United States|Georgetown University, Washington, District of Columbia, United States|Emory University, Atlanta, Georgia, United States|Northwestern University, Chicago, Illinois, United States|University of Iowa, Iowa City, Iowa, United States|Kalispell Regional Medical Center, Kalispell, Montana, United States|Montefiore Medical Center, Bronx, New York, United States|Columbia University Medical Center, New York, New York, United States|Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States|University of Pennsylvania (U Penn), Philadelphia, Pennsylvania, United States|Main Line Health - Lankenau Medical Center, Wynnewood, Pennsylvania, United States|Sanford Health, Sioux Falls, South Dakota, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1500
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19|Improvement in disease severity|Health care utilization|Frequency of serious AEs|Mortality
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NCT05085574
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Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1) |
Not yet recruiting |
Phase 2 |
Jan/01/2022 |
Nov/01/2022 |
- Alternative id - LDOS-21-001-01
- Interventions - Drug: Famotidine|Drug: Celecoxib|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 404
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time-to-event to achieve WHO level ≤3|Death rate|Hospital discharge to chronic palliative care|Hospital discharge with no additional medical care|Related adverse events (AEs) and serious adverse events (SAEs)|Study discontinuation due to related AEs or SAEs
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NCT05077332
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LEAP-CT for Treatment of COVID-19 Patients (Master Protocol) |
Active, not recruiting |
Phase 2 |
Dec/29/2021 |
Nov/01/2022 |
- Alternative id - LDOS-21-001
- Interventions - Drug: Famotidine|Drug: Celecoxib|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - US02-04: Integrated Health Solutions, Miami, Florida, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 2000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - (LDOS-21-001-01) Time-to-event to achieve WHO level ≤3|(LDOS-21-001-01) All-Cause Mortality rate|(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity|(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality)
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NCT05077969
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Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2) |
Recruiting |
Phase 2 |
Dec/29/2021 |
Nov/01/2022 |
- Alternative id - LDOS-21-001-02
- Interventions - Drug: Famotidine|Drug: Celecoxib|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Integrated Therapeutic Solutions USA, Inc., Newport Beach, California, United States|Integrated Therapeutic Solutions USA, Inc., Miami, Florida, United States|Integrated Health Solutions USA, Inc., Atlanta, Georgia, United States|Integrated Therapeutic Solutions USA, Inc., Chicago, Illinois, United States|Integrated Therapeutic Solutions USA, Inc, Gaithersburg, Maryland, United States|Integrated Therapeutic Solutions USA, Inc., Newark, New Jersey, United States|Integrated Therapeutic Solutions USA, Inc., New York, New York, United States|Integrated Therapeutic Solutions USA, Inc., Huntingdon, Pennsylvania, United States|Integrated Therapeutic Solutions USA, Inc., Charleston, South Carolina, United States|Integrated Therapeutic Solutions USA, Inc., Dallas, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 1465
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity|Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).|Incidence of Treatment-Emergent Serious Adverse Events (SAE) as assessed by participant withdrawal|Incidence of death
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