Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia

• Status: Completed
• Trial end date: 2021-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.

Recent publications show that a significant number of COVID-19 patients are co-infected with one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19 disease and a considerable number of patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin and not severe enough for requiring hospitalization. It therefore seems reasonable to adopt therapeutic strategies for these patients that are effective and easy to follow in the outpatient setting.

Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad spectrum of activity and is particularly active against the bacterial pathogens involved in community respiratory tract infections. Besides that, the use of CDN has been associated with a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and mediators of epithelial damage. The aim of this study is to demonstrate that CDN improves clinical condition in patients with mild-moderate COVID-19 and symptoms of bacterial pneumonia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meiji Pharma Spain S.A.
• Treatments: Cefditoren; Cefditoren pivoxil

Criteria

Inclusion Criteria:

• Adult ≥18 years

• Positive for SARS CoV-2

• Radiological and clinical signs of mild-moderate pneumonia

• Fever ≥37.7 ºC

• Sat O2> 94% and respiratory rate <24 on admission

• Able of taking oral medication

• HIV negative

• Written and signed consent

Exclusion Criteria:

• Concomitant treatments with drugs of demonstrated or potential action against SARS CoV-2 within the previous 24 hours.

• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5 times the upper limit

• corrected QT (QTc) interval prolongation> 450 msg,

• Moderate or severe renal impairment (creatinine<50ml/min)

• Severe hepatic impairment (Child-Pugh C)

• Pregnancy or childbearing

• Allergy to penicillin or any other beta-lactam

• Primary carnitine deficiency

• Malabsorption or swallowing problems

• Inability to understand and follow study procedures