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

2000 Participants Needed

Trial Summary

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 the combination of Celecoxib and Famotidine generally safe for humans?

Celecoxib is generally considered safe for humans, with a better gastrointestinal safety profile compared to other similar drugs, but it may still cause some side effects, especially in people with certain conditions like heart disease or allergies to sulfonamides. Famotidine, commonly used to reduce stomach acid, is also generally safe, but like any medication, it can have side effects. Always consult with a healthcare provider to understand the risks and benefits for your specific situation. ^{1 2 3 4 5}

How is the drug Celecoxib + Famotidine for COVID-19 different from other treatments?

Celecoxib + Famotidine is unique because it combines an anti-inflammatory drug (Celecoxib) with a stomach acid reducer (Famotidine), which is not a common combination for treating COVID-19. This approach may offer a novel way to manage inflammation and other symptoms associated with the virus. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a combination of famotidine and celecoxib to help hospitalized COVID-19 patients and newly infected individuals. The goal is to see if these drugs can reduce inflammation and help fight the virus. Famotidine is usually used to reduce stomach acid but is being tested to see if it can help treat COVID-19.

Research Team

Brian A Roberts, MS, PMP

Principal Investigator

Leidos, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]

2. Germany 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]. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Drug Discovery of New Anti-Inflammatory Compounds by Targeting Cyclooxygenases. [2022]

4. Croatia pubmed.ncbi.nlm.nih.gov

[Safety of celecoxib administration]. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Potentially inappropriate concomitant medicine use with the selective COX-2 inhibitor celecoxib: Analysis and comparison of spontaneous adverse event reports from Australia, Canada and the USA. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The usefulness of a new triple combination treatment utilizing methotrexate, salazosulfapyridine, and bucillamine in rheumatoid arthritis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine in patients with rheumatoid arthritis. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Basic therapeutic combination therapy in chronic polyarthritis: an overview]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention and treatment of Pneumocystis carinii pneumonia. [2007]

10. Italy pubmed.ncbi.nlm.nih.gov

Combination therapy with DMARDs and biological agents in collagen-induced arthritis. [2017]