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Trial record 10 of 17 for:    famotidine | COVID-19

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085574
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Leidos Life Sciences

Brief Summary:
This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib in patients hospitalized with moderate-to-severe COVID-19 (based on World Health Organization [WHO] Ordinal Scale for Clinical Improvement). Both famotidine and celecoxib separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and appear to have separate and complementary mechanisms of action.

Condition or disease Intervention/treatment Phase
2019 Novel Coronavirus Disease 2019 Novel Coronavirus Infection 2019-nCoV Disease 2019-nCoV Infection COVID-19 Pandemic COVID-19 Virus Disease COVID-19 Virus Infection Covid19 Coronavirus Disease 2019 SARS-CoV-2 Infection SARS-CoV-2 Acute Respiratory Disease COVID-19 Drug: Famotidine Drug: Celecoxib Drug: Placebo Phase 2

Detailed Description:

Participants will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 202 subjects per group as follows:

Group 1 (study product) subjects 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, subjects will continue their famotidine treatment for an additional 9 days.

Group 2 (reference therapy) subjects will receive matching placebos QID and BID, for 5 days. Following this 5-day period, subjects will continue to receive matching famotidine placebo, QID, for an additional 9 days.

Safety, efficacy and pharmacokinetics of famotidine and celecoxib will be evaluated.

All participants will receive the standard of care (SOC), which typically consists of remdesivir, decadron (dexamethasone), lovenox, tociluzimab, and convalescent plasma. At the discretion of the investigator, study treatment can be stopped and dexamethasone initiated in study participants who require supplemental oxygen (WHO 5) as outlined in the NIH COVID-19 Treatment Guidelines. Investigators are required to stop study treatment and initiate dexamethasone, as indicated in participants who require high-flow oxygen (WHO 6), non-invasive ventilation (NIV; WHO 6), invasive mechanical ventilation (WHO 7-8) or extracorporeal membrane oxygenation (ECMO; WHO 9), in accordance with the NIH COVID-19 Treatment Guidelines. The NIH COVID-19 Treatment Guidelines recommend against the use of dexamethasone only in hospitalized patients not requiring supplemental oxygen (WHO 4).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects randomized 1:1, study drug:placebo
Masking: Single (Participant)
Masking Description: Single-blind
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Treatment in Moderate-to-severe Patients Hospitalized for COVID-19
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Group 1 (Study Product)
Subjects 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, subjects will continue their famotidine treatment for an additional 9 days.
Drug: Famotidine
80 mg tablet, QID for 14 days
Other Name: Pepcid

Drug: Celecoxib
400 mg (initial dose), then 200 mg capsule, BID for 5 days
Other Name: Celebrex

Placebo Comparator: Group 2 (Reference Therapy)
Subjects will receive matching placebos QID and BID, for 5 days. Following this 5-day period, subjects will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Drug: Placebo
tablet, QID for 14 days; capsule, BID for 5 days




Primary Outcome Measures :
  1. Time-to-event to achieve WHO level ≤3 [ Time Frame: 30 days ]
    Evaluation of the time-to-event to achieve a WHO level score ≤3

  2. Death rate [ Time Frame: 30 days ]
    Evaluation of the time-to-event where all-cause mortality occurs


Secondary Outcome Measures :
  1. Hospital discharge to chronic palliative care [ Time Frame: 30 days ]
    Measured incidence of hospital discharge to chronic palliative care

  2. Hospital discharge with no additional medical care [ Time Frame: 30 days ]
    Measured incidence of hospital discharge with no additional medical care required

  3. Related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 90 days ]
    Measured incidence of related AEs and SAEs

  4. Study discontinuation due to related AEs or SAEs [ Time Frame: 90 days ]
    Measured incidence of study discontinuation due to related AEs or SAEs


Other Outcome Measures:
  1. Pharmacokinetic (PK) endpoint-Assess area under the curve [ Time Frame: 14 days ]
    Measure area under the curve (AUC) for famotidine and celecoxib combination in 10 patients per group

  2. Pharmacokinetic (PK) endpoint-Assess time to maximum plasma concentration [ Time Frame: 14 days ]
    Measure time to maximum plasma concentration (tmax) for famotidine and celecoxib combination in 10 patients per group

  3. Pharmacokinetic (PK) endpoint-Assess maximum serum concentration [ Time Frame: 14 days ]
    Measure maximum serum concentration (Cmax) for famotidine and celecoxib combination in 10 patients per group

  4. Exploratory endpoint-Incidence of symptom reduction [ Time Frame: 14 days ]
    Cumulative incidence of clinically significant symptom reduction (severity and duration) using COVID-19 Symptom Score

  5. Exploratory endpoint-Incidence of clinical improvement [ Time Frame: 14 days ]
    Cumulative incidence of clinically significant symptom reduction (severity and duration) using WHO Ordinal Scale for Clinical Improvement

  6. Special Assessment - High-resolution computed tomography (HRCT), 20 patients/group, change from baseline [ Time Frame: Study Day 1 (baseline), Day 16 (discharge), 30 days after first dose, and 90 days after first dose ]
    HRCT scan of the chest

  7. Special Assessment - Total lung capacity (TLC), 20 patients/group, change from baseline [ Time Frame: Study Day 1 (baseline), 16 (discharge), 30 days after first dose, and 90 days after first dose ]
    TLC

  8. Special Assessment - Prostaglandin E2 (PGE2), 20 patients/group, change from baseline [ Time Frame: Study Day 1 (baseline), 16 (discharge), 30 days after first dose, and 90 days after first dose ]
    PGE2 testing

  9. Special Assessments - Urinalysis, 20 patients/group, change from baseline [ Time Frame: Study Day 1 (baseline) and 16 (discharge) ]
    Urinalysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 COVID-19 or symptom onset within 7 days of hospitalization, as shown by medical history, physical exam, and laboratory tests (PCR), and who have been hospitalized for COVID-19 at WHO Grade 4-5.
  • Contraceptive use by men or women should be consistent with Appendix 4 of the Master Protocol (LDOS-21-001).
  • Capable of understanding and providing a signed informed consent form.
  • Reliable access to the internet.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Pregnant or breastfeeding
  • History of HIV
  • Ongoing treatment that cannot be temporarily discontinued during the study: anti-inflammatory treatment (nonsteroidal anti-inflammatory drugs [NSAIDS]);corticosteroids; antimalarials; antiarrhythmics; tricyclic antidepressants; natalizumab; quinolones; macrolides; and agalsidase alfa and beta

    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 famotidine, celecoxib, or other COVID-19 clinical investigational treatment(s) within the past 30 days or current participation in another investigational clinical trial
  • History of immunosuppression
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • Rejection of participation at the discretion of the Principal Investigator or Sponsor
  • Any contraindication for famotidine or celecoxib treatment:

    a. Famotidine or celecoxib hypersensitivity; b. Retinopathy, visual field or visual acuity disturbances; c. History of cardiovascular disease, such as congestive heart failure, QT prolongation, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias, as determined at screening electrocardiogram (ECG) or medical history; d. Potassium <3 mEq/L (milliequivalent/liter) as determined at Visit 1; e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 upper normal limit, as determined at Visit 1; f. Previous myocardial infarction; e. Myasthenia gravis; h. Psoriasis or porphyria; i. Glomerular clearance, 60 mL/min; j. Previous history of severe hypoglycemia; k. 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; l. Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085574


Contacts
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Contact: Brian A Roberts, MS, PMP 240-529-0455 brian.a.roberts@leidos.com
Contact: Tilly Lawrence, BSN, RN 240-529-0497 tilly.lawrence@leidos.com

Sponsors and Collaborators
Leidos Life Sciences
United States Department of Defense
Investigators
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Study Director: Brian A Roberts, MS, PMP Leidos, Inc.
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Responsible Party: Leidos Life Sciences
ClinicalTrials.gov Identifier: NCT05085574    
Other Study ID Numbers: LDOS-21-001-01
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make individual participant data (IPD) available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leidos Life Sciences:
COVID-19
COVID
COVID19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Famotidine
Infections
Communicable Diseases
Virus Diseases
Coronavirus Infections
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action