Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1) : A Phase 2 Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Treatment in Moderate-to-severe Patients Hospitalized for COVID-19

Participants will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 202 subjects per group as follows:Group 1 (study product) subjects will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib PO, 2 times per day (BID), for 5 days. Following this 5-day period, subjects will continue their famotidine treatment for an additional 9 days.Group 2 (reference therapy) subjects 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.Safety, efficacy and pharmacokinetics of famotidine and celecoxib will be evaluated.All participants will receive the standard of care (SOC), which typically consists of remdesivir, decadron (dexamethasone), lovenox, tociluzimab, and convalescent plasma. At the discretion of the investigator, study treatment can be stopped and dexamethasone initiated in study participants who require supplemental oxygen (WHO 5) as outlined in the NIH COVID-19 Treatment Guidelines. Investigators are required to stop study treatment and initiate dexamethasone, as indicated in participants who require high-flow oxygen (WHO 6), non-invasive ventilation (NIV; WHO 6), invasive mechanical ventilation (WHO 7-8) or extracorporeal membrane oxygenation (ECMO; WHO 9), in accordance with the NIH COVID-19 Treatment Guidelines. The NIH COVID-19 Treatment Guidelines recommend against the use of dexamethasone only in hospitalized patients not requiring supplemental oxygen (WHO 4)..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 10. Okt. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 COVID-19 Communicable Diseases Coronavirus Infections Infections Phase: Phase 2 Recruitment Status: Withdrawn Respiration Disorders Respiratory Tract Diseases Study Type: Interventional Virus Diseases

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: October 20, 2021, Last downloaded: ClinicalTrials.gov processed this data on October 18, 2023, Last updated: October 18, 2023

Study ID:	NCT05085574 LDOS-21-001-01
Veröffentlichungen zur Studie:

fisyears:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	CTG007952597