Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

July 20, 2022 updated by: Leidos Life Sciences

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

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

Study Overview

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Newport Beach, California, United States, 92603
        • Integrated Therapeutic Solutions USA, Inc.
    • Florida
      • Miami, Florida, United States, 33126
        • Integrated Therapeutic Solutions USA, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30363
        • Integrated Health Solutions USA, Inc.
      • Hazlehurst, Georgia, United States, 31539
        • Integrated Therapeutic Solutions USA, Inc
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Integrated Therapeutic Solutions USA, Inc.
    • Kentucky
      • Prospect, Kentucky, United States, 40059
        • Integrated Therapeutic Solutions USA, Inc
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Integrated Therapeutic Solutions USA, Inc
      • Gaithersburg, Maryland, United States, 20878
        • Integrated Therapeutic Solutions USA, Inc
      • Rockville, Maryland, United States, 20850
        • Integrated Therapeutic Solutions USA, Inc
    • Michigan
      • Dearborn, Michigan, United States, 48120
        • Integrated Therapeutic Solutions USA, Inc
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Integrated Therapeutic Solutions USA, Inc.
    • New York
      • New York, New York, United States, 10005
        • Integrated Therapeutic Solutions USA, Inc.
    • Pennsylvania
      • Huntingdon, Pennsylvania, United States, 16652
        • Integrated Therapeutic Solutions USA, Inc.
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Integrated Therapeutic Solutions USA, Inc.
    • Texas
      • Dallas, Texas, United States, 75219
        • Integrated Therapeutic Solutions USA, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

    1. drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;
    2. tizanidine (CYP1A2) substrate;
    3. drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors (SNRIs]);
    4. angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;
    5. diuretics;
    6. 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:

    1. Famotidine or celecoxib hypersensitivity
    2. Retinopathy, visual field or visual acuity disturbances
    3. History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias
    4. Myasthenia gravis
    5. Psoriasis or porphyria
    6. History of renal failure/dialysis or a glomerular clearance <60 mL/min
    7. History of severe hypoglycemia
    8. Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C
    9. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
80 mg tablet, QID for 14 days
Other Names:
  • Pepcid
400 mg (initial dose), then 200 mg capsule, BID for 5 days
Other Names:
  • Celebrex
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.
tablet, QID for 14 days; capsule, BID for 5 days

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
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.
Through Day 30
Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).
Time Frame: Through Day 30
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.
Through Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Serious Adverse Events (SAE) as assessed by participant withdrawal
Time Frame: 90 days
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.
90 days
Incidence of death
Time Frame: 90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Brian A Roberts, MS, PMP, Leidos, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

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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