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

NCT04709172 | Completed Phase 4

• 1 other identifier: MPS-ME1207/401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; pneumonia; cefditoren; outpatient

Outcome Measures

Primary Outcomes (2)

• Evolution of patient status

  Evolution of the status of the patient defined by the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19. This is a 0-8 score where higher scores mean a better or worse outcome.

  28 days

• Assessment of Clinical improvement

  Evaluation of clinical condition through a Clinical Improvement questionnaire.

  28 days

Secondary Outcomes (3)

• Additional visit to the Emergency room

  28 days

• Need for hospitalization

  28 days

• Occurrence of adverse events

  28 days

Study Arms (1)

Cefditoren pivoxil 400mg

EXPERIMENTAL

Cefditoren pivoxil 400mg bid for 7 days

Drug: Cefditoren pivoxil 400mg

Interventions

Cefditoren pivoxil 400mg DRUG

Cefditoren pivoxil 400mg bid for 7 days

Also known as: CDN-PI 400mg

Cefditoren pivoxil 400mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meiji Pharma Spain S.A.: lead

Study Sites (1)

HU Henares

Coslada, Madrid, 28822, Spain

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

cefditoren pivoxil

Condition Hierarchy (Ancestors)

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

Study Officials

• Cristóbal Rodríguez Leal, Dr

  HU Henares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 5, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-01

Locations

ES (1)