What side effects are associated with this type of intervention?

Common treatments for COVID-19 include hydroxychloroquine, remdesivir, and interleukin-6 inhibitors. Hydroxychloroquine has been associated with side effects such as cardiac arrhythmias, gastrointestinal disturbances, and retinal toxicity. Remdesivir's side effects include liver enzyme elevations, gastrointestinal symptoms, and potential allergic reactions. Interleukin-6 inhibitors can cause increased risk of infections, liver enzyme abnormalities, and infusion-related reactions. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

The FDA has approved remdesivir for the treatment of COVID-19 in both hospitalized and nonhospitalized adults and children aged ≥28 days who weigh ≥3 kg. Remdesivir is an antiviral that inhibits RNA-dependent RNA polymerase. Monoclonal antibodies, such as bebtelovimab, were also authorized for use but are no longer authorized due to their variable activity against different SARS-CoV-2 variants. Additionally, inhaled corticosteroids like ciclesonide have shown some benefit in reducing emergency department visits or hospital admissions in nonsevere COVID-19 cases.

What other types of research exist?

Promising novel alternatives for COVID-19 treatment in 2024 include antiviral drugs, immunomodulatory drugs, and other novel approaches such as drug repurposing and inhaled nitric oxide (NO) therapy. These treatments are currently under investigation and show potential in managing COVID-19.

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Nonsteroidal Anti-inflammatory Drug

Celecoxib + Famotidine for COVID-19

Phase 2

Waitlist Available

Research Sponsored by Leidos Life Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Addendum #1 (LDOS-21-001-01) or * Addendum #2 (LDOS-21-001-02

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from Celecoxib may include stomach pain, swelling, dizziness, or heart issues. Famotidine could cause headache, constipation or diarrhea. Placebos typically have no active ingredients but can lead to perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(LDOS-21-001-01) All-Cause Mortality rate

(LDOS-21-001-01) Time-to-event to achieve WHO level ≤3

(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 (Study Product)Experimental Treatment2 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 Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Celecoxib

2019

Completed Phase 4

~1740

Famotidine

2005

Completed Phase 4

~1220

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral drugs like remdesivir, which inhibits viral RNA polymerase, and immunomodulatory agents such as dexamethasone, which reduces inflammation by suppressing the immune response. Monoclonal antibodies can neutralize the virus by targeting the spike protein, preventing it from entering cells. These treatments are essential for managing the disease as they can reduce viral load, mitigate severe inflammatory responses, and improve patient recovery rates. Tailoring these therapies to individual patient profiles is vital for optimizing outcomes and minimizing adverse effects.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.A brief review of the latest pharmacological treatments of COVID-19.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.