Celecoxib + Famotidine for COVID-19

Overseen By Tilly Lawrence, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Leidos Life Sciences

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, celecoxib (an anti-inflammatory medication) and famotidine (a medication that reduces stomach acid), to determine their effectiveness in treating COVID-19. Researchers aim to discover if these medications can improve symptoms or speed up recovery. Participants will receive either the study drugs or a placebo (a harmless pill that resembles the drug but has no effect) for comparison. Individuals diagnosed with COVID-19 and experiencing symptoms may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please refer to the specific addendums for detailed eligibility criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown mixed safety results when using celecoxib and famotidine together. While both drugs are well-known individually, their combination has raised some concerns. One study stopped this combination early due to potential harm. However, this does not mean they are always unsafe; caution is simply advised.

Celecoxib is often used for pain and swelling, such as in arthritis, and famotidine is commonly used for stomach issues like heartburn. Both drugs have a history of being well-tolerated when used separately. However, reactions can vary from person to person.

It is important to discuss any concerns or questions with the study team. They can provide more information and help determine if joining the trial is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of celecoxib and famotidine for COVID-19 because it offers a novel approach to managing inflammation and symptoms associated with the virus. Unlike traditional treatments that primarily focus on antiviral action, celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), targets inflammation and pain relief, potentially reducing the severity of COVID-19 symptoms. Famotidine, typically used for heartburn, is being explored for its potential anti-inflammatory and antiviral effects. This combination could provide a dual-action strategy that addresses both symptom relief and viral activity, setting it apart from the standard care options like remdesivir and dexamethasone.

What evidence suggests that celecoxib and famotidine might be an effective treatment for COVID-19?

Research shows that famotidine, a drug typically used for heartburn, might help reduce COVID-19 symptoms. Some studies suggest it could lessen the disease's severity, although the mechanism remains unclear. In this trial, one group of participants will receive famotidine with celecoxib to assess their combined effect on COVID-19 outcomes. A small study with 25 patients using both drugs showed some improvement, but the results were inconclusive. However, another trial halted the combination due to concerns about potential harm. Overall, more research is needed to determine if this combination is truly effective against COVID-19. ^{1 2 6 7 8}

Who Is on the Research Team?

Brian A Roberts, MS, PMP

Principal Investigator

Leidos, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with COVID-19. Specific eligibility details are in separate documents (Addendum #1 and #2), which likely outline the health status, age range, and other factors needed to join.

Inclusion Criteria

See Addendum #1 (LDOS-21-001-01) or Addendum #2 (LDOS-21-001-02) for eligibility criteria specific to the protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive famotidine and celecoxib for 5 days, followed by famotidine for an additional 9 days

2 weeks

Daily visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Celecoxib
• Famotidine
• Placebo

Trial Overview The study is testing Celecoxib and Famotidine against a placebo to see if they're effective in treating COVID-19 patients. It's part of a larger effort that includes both hospitalized and non-hospitalized patients.

How Is the Trial Designed?

Group I: Group 1 (Study Product) Experimental Treatment 2 Interventions

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.

Group II: Group 2 (Reference Therapy) Placebo Group 1 Intervention

Participants 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.

Celecoxib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Celebrex for:

• Pain relief
• Inflammation
• Osteoarthritis
• Rheumatoid arthritis
• Menstrual cramps
• Colorectal polyps prevention

Approved in European Union as Celebrex for:

• Symptomatic relief in osteoarthritis
• Symptomatic relief in rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea
• Adenomatous polyposis coli

Approved in Canada as Celebrex for:

• Symptomatic relief of osteoarthritis
• Symptomatic relief of rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea

Who Is Running the Clinical Trial?

Leidos Life Sciences

Lead Sponsor

Trials

3

Recruited

2,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Celecoxib is a selective COX-2 inhibitor that offers similar pain relief as traditional NSAIDs but has a safer gastrointestinal profile, making it a preferable option for patients at risk of GI complications.

Despite its GI safety, celecoxib carries similar risks of other adverse effects as NSAIDs, and caution is advised for certain populations, including the elderly and those with cardiovascular issues, as it does not provide antithrombotic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of celecoxib administration]. Babić-Naglić, D.[2017]

Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.

In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. Essex, MN., Zhang, RY., Berger, MF., et al.[2022]

In a study of 77 NSAID-sensitive patients, celecoxib was administered safely without any adverse effects, indicating it can be tolerated by individuals with a history of NSAID reactions.

Celecoxib does not exhibit cross-intolerance with other NSAIDs, making it a promising alternative for patients who have experienced adverse reactions to traditional NSAIDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The selective cyclooxygenase-2 inhibitor celecoxib is a safe alternative in patients with pseudo-allergic reactions to nonsteroidal anti-inflammatory drugs]. Ahlbach, S., Usadel, KH., Kaufmann, R., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05077332

NCT05077332 | LEAP-CT for Treatment of COVID-19 ... Hospitalized COVID-19 Patients Treated with Celecoxib and High Dose Famotidine ... Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients.

2. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=3646583

Hospitalized COVID-19 Patients Treated With Celecoxib ... We report a single institution, consecutive case series of 25 COVID-19 hospitalized patients treated with celecoxib and HD famotidine as adjuvant therapy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8021898/

COVID-19: Famotidine, Histamine, Mast Cells, and Mechanisms Clinical data suggest that famotidine may mitigate COVID-19 disease, but both mechanism of action and rationale for dose selection remain obscure. We have ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9981330/

Report of the first seven agents in the I-SPY COVID trial The data monitoring committee stopped Celecoxib/Famotidine for potential harm (median posterior HR for recovery 0.5, 95% credible interval ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05077969?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(covid19%20OR%20covid-19%20OR%20%22covid%2019%22%20OR%202019ncov%20OR%202019-ncov%20OR%20%222019%20ncov%22%20OR%20%222019%20Novel%20Coronavirus%22%20OR%20%222019%20novel%20cov%22%20OR%20(wuhan%20AND%20(ncov%20OR%20coronavirus)))))&rank=6

NCT05077969 | Leidos-Enabled Adaptive ... This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05077969

Study Details | NCT05077969 | Leidos-Enabled Adaptive ... 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 ...

7. thelancet.com thelancet.com/pdfs/journals/eclinm/PIIS2589-5370(23)00066-4.pdf

Report of the first seven agents in the I-SPY COVID trial Celecoxib/Famotidine was stopped early for potential harm. Adaptive platform trials may provide a useful approach to rapidly screen multiple ...

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05085574/

Trial | NCT05085574 This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib in patients hospitalized ...