| Trial registration number
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NCT05077332 |
Full text link
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05077332
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First author
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov
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Brian A Roberts, MS, PMP
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Contact
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov
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brian.a.roberts@leidos.com
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Registration date
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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2021-10-14
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Recruitment status
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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- for eligibility criteria specific to the protocol, see:
- addendum #1 (ldos-21-001-01) or
- addendum #2 (ldos-21-001-02)
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Exclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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None
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Number of arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Leidos Life Sciences
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Inclusion age min
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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2000
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primary outcome
Last imported at : Dec. 11, 2021, 1 a.m.
Source : ClinicalTrials.gov
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(LDOS-21-001-01) All-Cause Mortality rate;(LDOS-21-001-01) Time-to-event to achieve WHO level ≤3;(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality);(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity
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Notes
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1991, "treatment_name": "Celecoxib+famotidine", "treatment_type": "Non-steroidal anti-inflammatory+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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