- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077969
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)
A Virtual Phase 2 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Post-exposure Prophylaxis (PEP) for Newly-infected COVID-19 Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Qualifying patients will have been confirmed positive for COVID-19 and have symptoms of World Health Organization (WHO) Ordinal Scale for Clinical Improvement with scores of ≤3 on the 11-point scale and will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 659 participants per group, as follows:
Group 1 (study product) participants will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib (PO) 2 times per day (BID), for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Group 2 (reference therapy) participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Safety and efficacy of famotidine and celecoxib will be evaluated.
This is a completely virtual trial and you can participate from your own home. Please call 1-888-370-9330 to speak to someone regarding study participation in your area.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92603
- Integrated Therapeutic Solutions USA, Inc.
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Florida
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Miami, Florida, United States, 33126
- Integrated Therapeutic Solutions USA, Inc.
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Georgia
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Atlanta, Georgia, United States, 30363
- Integrated Health Solutions USA, Inc.
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Hazlehurst, Georgia, United States, 31539
- Integrated Therapeutic Solutions USA, Inc
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Illinois
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Chicago, Illinois, United States, 60611
- Integrated Therapeutic Solutions USA, Inc.
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Kentucky
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Prospect, Kentucky, United States, 40059
- Integrated Therapeutic Solutions USA, Inc
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Maryland
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Frederick, Maryland, United States, 21702
- Integrated Therapeutic Solutions USA, Inc
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Gaithersburg, Maryland, United States, 20878
- Integrated Therapeutic Solutions USA, Inc
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Rockville, Maryland, United States, 20850
- Integrated Therapeutic Solutions USA, Inc
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Michigan
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Dearborn, Michigan, United States, 48120
- Integrated Therapeutic Solutions USA, Inc
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New Jersey
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Newark, New Jersey, United States, 07102
- Integrated Therapeutic Solutions USA, Inc.
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New York
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New York, New York, United States, 10005
- Integrated Therapeutic Solutions USA, Inc.
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Pennsylvania
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Huntingdon, Pennsylvania, United States, 16652
- Integrated Therapeutic Solutions USA, Inc.
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South Carolina
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Charleston, South Carolina, United States, 29414
- Integrated Therapeutic Solutions USA, Inc.
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Texas
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Dallas, Texas, United States, 75219
- Integrated Therapeutic Solutions USA, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female participants must be at least 18 years of age, inclusive, at the time of signing the informed consent form.
- Confirmed SARS-CoV-2 polymerase chain reaction (PCR) positive patient within 5 days of enrollment, as shown by medical history and reported PCR test result.
- Reports having one or more symptoms consistent with SARS-CoV-2, as defined in Master Protocol Appendix 3 Table 4.
- COVID-19 diagnosis must be WHO grade ≤3.
- Contraceptive use by men or women should be consistent with Appendix 4 of the Master protocol (LDOS-21-001).
- Reliable access to the Internet via a browser installed on personal device or computer.
- Capable of understanding and providing signed informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding
- Ongoing antiviral or antiretroviral treatment
- Known history of HIV
Ongoing anti-inflammatory treatment that cannot be temporarily discontinued during the study. This includes nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids - including Dexamethasone (dexamethasone administration restricted to recommended standard of care use per NIH COVID-19 Guidelines)
- drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;
- tizanidine (CYP1A2) substrate;
- drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors (SNRIs]);
- angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;
- diuretics;
- digoxin
- Ongoing treatment that cannot be temporarily discontinued during the study, with: antimalarials, antiarrhythmics, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta
- Ongoing famotidine or celecoxib or other COVID-19 clinical investigational treatment(s) within the past 30 days, or current participation in another investigational clinical trial
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- History of immunosuppression
- Rejection of participation by Principal Investigator or Sponsor
Any contraindication for famotidine or celecoxib treatment:
- Famotidine or celecoxib hypersensitivity
- Retinopathy, visual field or visual acuity disturbances
- History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias
- Myasthenia gravis
- Psoriasis or porphyria
- History of renal failure/dialysis or a glomerular clearance <60 mL/min
- History of severe hypoglycemia
- Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C
- Known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history or experience with other CYP2C9 substrates, such as warfarin and phenytoin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1 (Study Product)
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days.
Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
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80 mg tablet, QID for 14 days
Other Names:
400 mg (initial dose), then 200 mg capsule, BID for 5 days
Other Names:
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Placebo Comparator: Group 2 (Reference Therapy)
Participants will receive matching placebos QID and BID, for 5 days.
Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
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tablet, QID for 14 days; capsule, BID for 5 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity
Time Frame: Through Day 30
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Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.
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Through Day 30
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Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).
Time Frame: Through Day 30
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Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.
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Through Day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Treatment-Emergent Serious Adverse Events (SAE) as assessed by participant withdrawal
Time Frame: 90 days
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Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.
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90 days
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Incidence of death
Time Frame: 90 days
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Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.
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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Brian A Roberts, MS, PMP, Leidos, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Coronavirus Infections
- Infections
- Communicable Diseases
- Virus Diseases
- Respiration Disorders
- Respiratory Tract Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Cyclooxygenase 2 Inhibitors
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Celecoxib
- Famotidine
Other Study ID Numbers
- LDOS-21-001-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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