Last reviewed · How we verify
NCT05085574
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)
Phase 2 trial testing Famotidine in 2019 Novel Coronavirus Disease. Withdrawn.
7 February 2023
Quick facts
| Lead sponsor | Leidos Life Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 7 February 2023 |
| Primary completion | 7 February 2023 |
| Estimated completion | 7 February 2023 |
Drugs / interventions tested
- Famotidine (famotidine) — full drug profile →
- Celecoxib (celecoxib) — full drug profile →
- Placebo
Conditions studied
- 2019 Novel Coronavirus Disease — all drugs for 2019 Novel Coronavirus Disease →
- 2019 Novel Coronavirus Infection — all drugs for 2019 Novel Coronavirus Infection →
- 2019-nCoV Disease — all drugs for 2019-nCoV Disease →
- 2019-nCoV Infection — all drugs for 2019-nCoV Infection →
Sponsor
Leidos Life Sciences
Who can join
18 and older, any sex, with 2019 Novel Coronavirus Disease or 2019 Novel Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib in patients hospitalized with moderate-to-severe COVID-19 (based on World Health Organization \[WHO\] Ordinal Scale for Clinical Improvement). Both famotidine and celecoxib separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and appear to have separate and complementary mechanisms of action.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05085574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Famotidine
Trials testing the same drug.
- NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
- NCT07101445 — Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injecti · Phase 4 · recruiting
- NCT06743243 — Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia · Phase 4 · enrolling by invitation
- NCT07018635 — A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Adm · Phase 1 · completed
- NCT06819670 — A Study to Prevent Infantile Spasms Relapse · Phase 2 · recruiting
Other Leidos Life Sciences trials
Trials by the same sponsor.
- NCT07190105 — Vagal Approaches on Long COVID-19 · NA · completed
- NCT05077332 — LEAP-CT for Treatment of COVID-19 Patients (Master Protocol) · Phase 2 · completed
- NCT05077969 — Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patie · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05085574 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Leidos Life Sciences
- Last refreshed: 10 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05085574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing