Status:
COMPLETED
Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia
Lead Sponsor:
Meiji Pharma Spain S.A.
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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% requ...
Detailed Description
The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The novel coronavirus is now referred to as severe and critica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04709172
Start Date
January 5 2021
End Date
August 15 2021
Last Update
October 6 2021
Active Locations (1)
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1
HU Henares
Coslada, Madrid, Spain, 28822