2019 Novel Coronavirus DiseasePhase 2NCT05085574
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)
A Phase 2 study testing Famotidine and Celecoxib in people with 2019 Novel Coronavirus Disease and 2019 Novel Coronavirus Infection, run by Leidos Life Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease
- What is being tested?
- Famotidine and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Feb 2023to 7 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;
- tizanidine (CYP1A2) substrate;
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- 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 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:
- 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.
About this study
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
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.
Read the 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).
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, 2019-nCoV Infection, COVID-19 Pandemic, COVID-19 Virus Disease
- Being tested
- Famotidine, Celecoxib, Placebo
- Keywords
- COVID-19, COVID, COVID19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
Also called Pepcid
80 mg tablet, QID for 14 days
CelecoxibDrug
Also called Celebrex
400 mg (initial dose), then 200 mg capsule, BID for 5 days
PlaceboDrug
tablet, QID for 14 days; capsule, BID for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Study Product) | Experimental | 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. Receives: Drug: Famotidine; Drug: Celecoxib |
| Group 2 (Reference Therapy) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-event to achieve WHO level ≤3
Evaluation of the time-to-event to achieve a WHO level score ≤3
Measured: 30 days
Death rate
Evaluation of the time-to-event where all-cause mortality occurs
Measured: 30 days
Secondary outcomes (4)
Hospital discharge to chronic palliative care
Measured incidence of hospital discharge to chronic palliative care
Measured: 30 days
Hospital discharge with no additional medical care
Measured incidence of hospital discharge with no additional medical care required
Measured: 30 days
Related adverse events (AEs) and serious adverse events (SAEs)
Measured incidence of related AEs and SAEs
Measured: 90 days
Study discontinuation due to related AEs or SAEs
Measured incidence of study discontinuation due to related AEs or SAEs
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start7 Feb 2023
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Why it stopped: COVID environment, lack of site confidence to enroll subjects, sites not suited to study procedures, decline of potential inpatient subjects at site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019 Novel Coronavirus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized 1:1, study drug:placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leidos Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Tilly Lawrence, BSN, RN, Study director, Leidos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085574
- Sponsor's protocol ID
- LDOS-21-001-01
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05085574
- Acronym / sponsor ID
- LDOS-21-001-01
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, 2019-nCoV Infection, COVID-19 Pandemic, COVID-19 Virus Disease
- Keywords
- COVID-19, COVID, COVID19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID environment, lack of site confidence to enroll subjects, sites not suited to study procedures, decline of potential inpatient subjects at site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leidos Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects randomized 1:1, study drug:placebo
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Study Product) | Experimental | Drug: Famotidine, Drug: CelecoxibSubjects 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. |
| Group 2 (Reference Therapy) | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamotidineAlso: Pepcid80 mg tablet, QID for 14 days | Drug | Group 1 (Study Product) |
| CelecoxibAlso: Celebrex400 mg (initial dose), then 200 mg capsule, BID for 5 days | Drug | Group 1 (Study Product) |
| Placebotablet, QID for 14 days; capsule, BID for 5 days | Drug | Group 2 (Reference Therapy) |
Primary outcome
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
Death rate
Time frame: 30 days
Evaluation of the time-to-event where all-cause mortality occurs
4 secondary outcomes
Hospital discharge to chronic palliative care
Time frame: 30 days
Hospital discharge with no additional medical care
Time frame: 30 days
Related adverse events (AEs) and serious adverse events (SAEs)
Time frame: 90 days
Study discontinuation due to related AEs or SAEs
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilly Lawrence, BSN, RN study director
Leidos, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Famotidine and Celecoxib in people with 2019 Novel Coronavirus Disease and 2019 Novel Coronavirus Infection, run by Leidos Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-event to achieve WHO level ≤3 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.