COVID-19 Clinical Trial
Official title:
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) to Evaluate the Safety and Efficacy of Drug Combinations in COVID-19 Patients
| Verified date | October 2023 |
| Source | Leidos Life Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.
| Status | Active, not recruiting |
| Enrollment | 2000 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | - For eligibility criteria specific to the protocol, see: - Addendum #1 (LDOS-21-001-01) or - Addendum #2 (LDOS-21-001-02) |
| Country | Name | City | State |
|---|---|---|---|
| United States | US02-04: Integrated Health Solutions | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Leidos Life Sciences | United States Department of Defense |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | (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 | |
| Primary | (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 | |
| Primary | (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 | |
| Primary | (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 |
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