A Phase 2 interventional study of Famotidine and Celecoxib in 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection and 2019-nCoV Disease, sponsored by Leidos Life Sciences. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Leidos Life Sciences · Phase 2, Interventional, and Treatment
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.
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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Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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
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.
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 · Drug: Celecoxib
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
80 mg tablet, QID for 14 days
Also known as: Pepcid
400 mg (initial dose), then 200 mg capsule, BID for 5 days
Also known as: Celebrex
tablet, QID for 14 days; capsule, BID for 5 days
Time-to-event to achieve WHO level ≤3
Evaluation of the time-to-event to achieve a WHO level score ≤3
Time frame: 30 days
Death rate
Evaluation of the time-to-event where all-cause mortality occurs
Time frame: 30 days
Hospital discharge to chronic palliative care
Measured incidence of hospital discharge to chronic palliative care
Time frame: 30 days
Hospital discharge with no additional medical care
Measured incidence of hospital discharge with no additional medical care required
Time frame: 30 days
Related adverse events (AEs) and serious adverse events (SAEs)
Measured incidence of related AEs and SAEs
Time frame: 90 days
Study discontinuation due to related AEs or SAEs
Measured incidence of study discontinuation due to related AEs or SAEs
Time frame: 90 days
Pharmacokinetic (PK) endpoint-Assess area under the curve
Measure area under the curve (AUC) for famotidine and celecoxib combination in 10 patients per group
Time frame: 14 days
Pharmacokinetic (PK) endpoint-Assess time to maximum plasma concentration
Measure time to maximum plasma concentration (tmax) for famotidine and celecoxib combination in 10 patients per group
Time frame: 14 days
Pharmacokinetic (PK) endpoint-Assess maximum serum concentration
Measure maximum serum concentration (Cmax) for famotidine and celecoxib combination in 10 patients per group
Time frame: 14 days
Exploratory endpoint-Incidence of symptom reduction
Cumulative incidence of clinically significant symptom reduction (severity and duration) using COVID-19 Symptom Score
Time frame: 14 days
Exploratory endpoint-Incidence of clinical improvement
Cumulative incidence of clinically significant symptom reduction (severity and duration) using WHO Ordinal Scale for Clinical Improvement
Time frame: 14 days
Special Assessment - High-resolution computed tomography (HRCT), 20 patients/group, change from baseline
HRCT scan of the chest
Time frame: Study Day 1 (baseline), Day 16 (discharge), 30 days after first dose, and 90 days after first dose
Special Assessment - Total lung capacity (TLC), 20 patients/group, change from baseline
TLC
Time frame: Study Day 1 (baseline), 16 (discharge), 30 days after first dose, and 90 days after first dose
Special Assessment - Prostaglandin E2 (PGE2), 20 patients/group, change from baseline
PGE2 testing
Time frame: Study Day 1 (baseline), 16 (discharge), 30 days after first dose, and 90 days after first dose
Special Assessments - Urinalysis, 20 patients/group, change from baseline
Urinalysis
Time frame: Study Day 1 (baseline) and 16 (discharge)
No study locations are listed for this record.
Plan to share: Undecided — It is not yet known if there will be a plan to make individual participant data (IPD) available.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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