2019 Novel Coronavirus DiseasePhase 2NCT05077969
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
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 at 15 sites in United States.
Trial summary
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… 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
- 4 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Dec 2021to 8 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Integrated Health Solutions USA, Inc.
Atlanta, Georgia, 30363
Integrated Therapeutic Solutions USA, Inc.
Charleston, South Carolina, 29414
Integrated Therapeutic Solutions USA, Inc.
Chicago, Illinois, 60611
Integrated Therapeutic Solutions USA, Inc.
Dallas, Texas, 75219
Integrated Therapeutic Solutions USA, Inc
Dearborn, Michigan, 48120
Integrated Therapeutic Solutions USA, Inc
Frederick, Maryland, 21702
Integrated Therapeutic Solutions USA, Inc
Gaithersburg, Maryland, 20878
Integrated Therapeutic Solutions USA, Inc
Hazlehurst, Georgia, 31539
Integrated Therapeutic Solutions USA, Inc.
Huntingdon, Pennsylvania, 16652
Integrated Therapeutic Solutions USA, Inc.
Miami, Florida, 33126
Integrated Therapeutic Solutions USA, Inc.
New York, New York, 10005
Integrated Therapeutic Solutions USA, Inc.
Newark, New Jersey, 07102
Integrated Therapeutic Solutions USA, Inc.
Newport Beach, California, 92603
Integrated Therapeutic Solutions USA, Inc
Prospect, Kentucky, 40059
Integrated Therapeutic Solutions USA, Inc
Rockville, Maryland, 20850
About this study
Official title: 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.
Read the 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.
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, 2019-nCoV Infection, COVID-19, COVID-19 Pandemic
- 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 | 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. Receives: Drug: Famotidine; Drug: Celecoxib |
| Group 2 (Reference Therapy) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity
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.
Measured: Through Day 30
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).
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.
Measured: Through Day 30
Secondary outcomes (2)
Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal
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.
Measured: 90 days
Incidence of Death
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.
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 posted14 Oct 2021
- Study start29 Dec 2021
- Primary completion28 Jun 2022
- Study completion8 Jul 2022
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Participants randomized 1:1, study drug:placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 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
- Brian A Roberts, MS, PMP, Study director, Leidos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077969
- Sponsor's protocol ID
- LDOS-21-001-02
- Status last verified
- Jul 2024
- First submitted
- 7 Oct 2021
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05077969
- Acronym / sponsor ID
- LDOS-21-001-02
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, 2019-nCoV Infection, COVID-19, COVID-19 Pandemic
- Keywords
- COVID-19, COVID, COVID19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Leidos Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Posted 9 Jul 2024
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. 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants randomized 1:1, study drug:placebo
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Study Product) | Experimental | Drug: Famotidine, Drug: CelecoxibParticipants 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. |
| Group 2 (Reference Therapy) | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (25 listed)
- 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)
- Ongoing treatment that cannot be temporarily discontinued during the study, with: antimalarials, antiarrhythmics, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta
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
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.
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.
2 secondary outcomes
Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal
Time frame: 90 days
Incidence of Death
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
Brian A Roberts, MS, PMP study director
Leidos, Inc.
15 sites in 1 country: see every site and its status.
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 at 15 sites in United States.
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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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 9 Jul 2024.