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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
Awards & highlights
Study Summary
This trial is for inpatient and outpatient studies that share common elements.
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.Check my eligibility
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.See study design
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(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 moreSide effects data
From 2010 Phase 2 trial • 255 Patients • NCT010621135%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Placebo
Additional Dose Celecoxib 200 mg
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
~1700
Find a Location
Who is running the clinical trial?
Leidos Life SciencesLead Sponsor
2 Previous Clinical Trials
9 Total Patients Enrolled
2 Trials studying COVID-19
9 Patients Enrolled for COVID-19
United States Department of DefenseFED
861 Previous Clinical Trials
225,194 Total Patients Enrolled
19 Trials studying COVID-19
4,975 Patients Enrolled for COVID-19
Brian A Roberts, MS, PMPStudy DirectorLeidos, Inc.
2 Previous Clinical Trials
9 Total Patients Enrolled
2 Trials studying COVID-19
9 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (Reference Therapy)
- Group 2: Group 1 (Study Product)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count for this clinical experiment?
"This clinical trial has now closed its recruitment phase; which began on December 29th 2021 and concluded on August 15th 2022. If you're searching for other medical studies, there are 1866 trials currently enrolling patients with COVID-19 and 51 active studies investigating the efficacy of Celecoxib."
Answered by AI
For which maladies is Celecoxib commonly prescribed?
"Celecoxib is frequently prescribed to address muscular spasms, as well as rheumatoid arthritis, juvenile idiopathic arthritis and acid indigestion."
Answered by AI
Is this trial recruiting participants at present?
"According to the clinicaltrials.gov page, this particular medical trial is not currently recruiting patients, as its last edit was on August 15th 2022. Nonetheless, there are a plethora of other trials out there that require participants and presently remain open for recruitment."
Answered by AI
To what extent does Celecoxib present a health risk for individuals?
"Due to only having proof of safety, and not efficacy, celecoxib received a rating of 2 on our team's scale."
Answered by AI
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