COVID-19 PneumoniaPhase 4NCT04709172
Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia
A Phase 4 study testing Cefditoren pivoxil 400mg in people with COVID-19 Pneumonia, run by Meiji Pharma Spain S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Cefditoren pivoxil 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jan 2021to 15 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Allergy to penicillin or any other beta-lactam
- Primary carnitine deficiency
- Malabsorption or swallowing problems
- Inability to understand and follow study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-controlled Pilot Study to Evaluate the Efficacy and Safety of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia
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.
Read the 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 critical acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.
Recent publications show that a variable 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 in a retrospective study, secondary infection was observed in 50% of non-survivor patients.
In COVID-19 patients the elevated inflammatory cytokines and other inflammatory mediators present suggest that a cytokine storm, also known as cytokine release syndrome (CRS), may play a major role in the pathology of this disease. The elevated cytokine levels, specifically IL-6, may also be responsible for the lethal complications of COVID-19. Therefore, the interleukin-6 (IL-6) blockade has been proposed as one of the strategies to manage COVID-19-induced CRS.
A considerable number of COVID-19 patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin 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 to avoid overloading the Health System.
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. The results of clinical trials with CDN on community-acquired pneumonia showed percentages of clinical and microbiological efficacy around 85%. On the other hand, 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 such as Krebs von den Lungen-6 (KL-6).
Considering the above and the current estate of knowledge against SARS-CoV-2, we have considered of relevance to study the efficacy of CDN in a series of patients with mild-moderate COVID-19 and with symptoms compatible with pneumonia of presumed bacterial origin, seen at the Emergency room of a public hospital and followed on outpatient basis.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Cefditoren pivoxil 400mg
- Keywords
- COVID-19, pneumonia, cefditoren, outpatient
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefditoren pivoxil 400mgDrug
Also called CDN-PI 400mg
Cefditoren pivoxil 400mg bid for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Cefditoren pivoxil 400mg | Experimental | Cefditoren pivoxil 400mg bid for 7 days Receives: Drug: Cefditoren pivoxil 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Assessment of Clinical improvement
Evaluation of clinical condition through a Clinical Improvement questionnaire.
Measured: 28 days
Secondary outcomes (3)
Additional visit to the Emergency room
New attendance to the hospital due to worsening
Measured: 28 days
Need for hospitalization
Hospitalization due to worsening
Measured: 28 days
Occurrence of adverse events
Adverse reactions
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start5 Jan 2021
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Pharma Spain S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristóbal Rodríguez Leal, Dr, Principal investigator, HU Henares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709172
- Sponsor's protocol ID
- MPS-ME1207/401
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-controlled Pilot Study to Evaluate the Efficacy and Safety of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia
- ClinicalTrials.gov ID
- NCT04709172
- Acronym / sponsor ID
- MPS-ME1207/401
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, pneumonia, cefditoren, outpatient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meiji Pharma Spain S.A.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 critical acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.
Recent publications show that a variable 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 in a retrospective study, secondary infection was observed in 50% of non-survivor patients.
In COVID-19 patients the elevated inflammatory cytokines and other inflammatory mediators present suggest that a cytokine storm, also known as cytokine release syndrome (CRS), may play a major role in the pathology of this disease. The elevated cytokine levels, specifically IL-6, may also be responsible for the lethal complications of COVID-19. Therefore, the interleukin-6 (IL-6) blockade has been proposed as one of the strategies to manage COVID-19-induced CRS.
A considerable number of COVID-19 patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin 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 to avoid overloading the Health System.
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. The results of clinical trials with CDN on community-acquired pneumonia showed percentages of clinical and microbiological efficacy around 85%. On the other hand, 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 such as Krebs von den Lungen-6 (KL-6).
Considering the above and the current estate of knowledge against SARS-CoV-2, we have considered of relevance to study the efficacy of CDN in a series of patients with mild-moderate COVID-19 and with symptoms compatible with pneumonia of presumed bacterial origin, seen at the Emergency room of a public hospital and followed on outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefditoren pivoxil 400mg | Experimental | Drug: Cefditoren pivoxil 400mgCefditoren pivoxil 400mg bid for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefditoren pivoxil 400mgAlso: CDN-PI 400mgCefditoren pivoxil 400mg bid for 7 days | Drug | Cefditoren pivoxil 400mg |
Primary outcome
Evolution of patient status
Time frame: 28 days
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.
Assessment of Clinical improvement
Time frame: 28 days
Evaluation of clinical condition through a Clinical Improvement questionnaire.
3 secondary outcomes
Additional visit to the Emergency room
Time frame: 28 days
Need for hospitalization
Time frame: 28 days
Occurrence of adverse events
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristóbal Rodríguez Leal, Dr principal investigator
HU Henares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefditoren pivoxil 400mg in people with COVID-19 Pneumonia, run by Meiji Pharma Spain S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of patient status (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.