LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)

NCT05077332 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LDOS-21-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.

Conditions

COVID-19 Virus Disease; COVID-19 Virus Infection; Coronavirus Disease 2019; SARS-CoV-2 Infection; SARS-CoV-2 Acute Respiratory Disease; COVID-19; 2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; 2019-nCoV Infection; COVID-19 Pandemic

Keywords

COVID-19; COVID; COVID19; SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

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

  Evaluation of the time-to-event to achieve a WHO level score ≤3

  30 days

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

  Measured in whole numbers by participants removed from the study with reason of "death" in the electronic data capture system

  30 days

• (LDOS-21-001-02) 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

  30 days

• (LDOS-21-001-02) 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.

  30 days

Study Arms (2)

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.

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, subjects will continue to receive matching famotidine placebo, QID, for an additional 9 days.

Other: Placebo

Interventions

Famotidine DRUG

80 mg tablet, QID for 14 days

Also known as: Pepcid

Group 1 (Study Product)

Celecoxib DRUG

400 mg (initial dose) then 200 mg capsule, BID for 5 days

Also known as: Celebrex

Group 1 (Study Product)

Placebo OTHER

tablet, QID for 14 days; capsule, BID for 5 days

Group 2 (Reference Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* For eligibility criteria specific to the protocol, see: * Addendum #1 (LDOS-21-001-01) or * Addendum #2 (LDOS-21-001-02)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leidos Life Sciences: lead
• United States Department of Defense: collaborator

Study Sites (1)

US02-04: Integrated Health Solutions

Miami, Florida, 33126, United States

Location

Related Publications (10)

• Malone RW, Tisdall P, Fremont-Smith P, Liu Y, Huang XP, White KM, Miorin L, Moreno E, Alon A, Delaforge E, Hennecker CD, Wang G, Pottel J, Blair RV, Roy CJ, Smith N, Hall JM, Tomera KM, Shapiro G, Mittermaier A, Kruse AC, Garcia-Sastre A, Roth BL, Glasspool-Malone J, Ricke DO. COVID-19: Famotidine, Histamine, Mast Cells, and Mechanisms. Front Pharmacol. 2021 Mar 23;12:633680. doi: 10.3389/fphar.2021.633680. eCollection 2021.

  PMID: 33833683 BACKGROUND

• Janowitz T, Gablenz E, Pattinson D, Wang TC, Conigliaro J, Tracey K, Tuveson D. Famotidine use and quantitative symptom tracking for COVID-19 in non-hospitalised patients: a case series. Gut. 2020 Sep;69(9):1592-1597. doi: 10.1136/gutjnl-2020-321852. Epub 2020 Jun 4.

  PMID: 32499303 BACKGROUND

• Hogan Ii RB, Hogan Iii RB, Cannon T, Rappai M, Studdard J, Paul D, Dooley TP. Dual-histamine receptor blockade with cetirizine - famotidine reduces pulmonary symptoms in COVID-19 patients. Pulm Pharmacol Ther. 2020 Aug;63:101942. doi: 10.1016/j.pupt.2020.101942. Epub 2020 Aug 29.

  PMID: 32871242 BACKGROUND

• Tomera K, Malone R, Kittah J. Hospitalized COVID-19 Patients Treated with Celecoxib and High Dose Famotidine Adjuvant Therapy Sow Significant Clinical Responses. Frontiers in Pharmacology. 2021.

  BACKGROUND

• Sun C, Chen Y, Hu L, Wu Y, Liang M, Ayaz Ahmed M, Bhan C, Guo Z, Yang H, Zuo Y, Yan Y, Zhou Q. Does Famotidine Reduce the Risk of Progression to Severe Disease, Death, and Intubation for COVID-19 Patients? A Systemic Review and Meta-Analysis. Dig Dis Sci. 2021 Nov;66(11):3929-3937. doi: 10.1007/s10620-021-06872-z. Epub 2021 Feb 24.

  PMID: 33625613 BACKGROUND

• Shoaibi A, Fortin SP, Weinstein R, Berlin JA, Ryan P. Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients. Am J Gastroenterol. 2021 Apr;116(4):692-699. doi: 10.14309/ajg.0000000000001153.

  PMID: 33982938 BACKGROUND

• Sander WJ, O'Neill HG, Pohl CH. Prostaglandin E2 As a Modulator of Viral Infections. Front Physiol. 2017 Feb 14;8:89. doi: 10.3389/fphys.2017.00089. eCollection 2017.

  PMID: 28261111 BACKGROUND

• Morimoto K, Shirata N, Taketomi Y, Tsuchiya S, Segi-Nishida E, Inazumi T, Kabashima K, Tanaka S, Murakami M, Narumiya S, Sugimoto Y. Prostaglandin E2-EP3 signaling induces inflammatory swelling by mast cell activation. J Immunol. 2014 Feb 1;192(3):1130-7. doi: 10.4049/jimmunol.1300290. Epub 2013 Dec 16.

  PMID: 24342806 BACKGROUND

• Hong W, Chen Y, You K, Tan S, Wu F, Tao J, Chen X, Zhang J, Xiong Y, Yuan F, Yang Z, Chen T, Chen X, Peng P, Tai Q, Wang J, Zhang F, Li YX. Celebrex Adjuvant Therapy on Coronavirus Disease 2019: An Experimental Study. Front Pharmacol. 2020 Nov 6;11:561674. doi: 10.3389/fphar.2020.561674. eCollection 2020.

  PMID: 33312125 BACKGROUND

• Chen JS, Alfajaro MM, Chow RD, Wei J, Filler RB, Eisenbarth SC, Wilen CB. Non-steroidal anti-inflammatory drugs dampen the cytokine and antibody response to SARS-CoV-2 infection. J Virol. 2021 Mar 10;95(7):e00014-21. doi: 10.1128/JVI.00014-21. Epub 2021 Jan 13.

  PMID: 33441348 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Famotidine; Celecoxib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Pyrazoles

Study Officials

• Brian A Roberts, MS, PMP

  Leidos, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Only the participant is blinded in LDOS-21-001-01 (Addendum #1; inpatient study); All are blinded in LDOS-21-001-02 (Addendum #2; outpatient study).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects randomized 1:1, study drug:placebo

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 14, 2021
• Study Start: December 29, 2021
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)