COVID-19Phase 2Caards-1NCT04384731
Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19
A Phase 2 study testing poractant alfa in people with COVID-19 and ARDS, Human, run by Dr Christophe LENCLUD at 1 site in France.
Trial summary
Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, ARDS, Human
- What is being tested?
- poractant alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2020to 31 Jul 2021
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years
- Intensive care unit admission.
- Intubation and mechanical ventilation since less than 72h.
- Positive end-expiratory pressure ≥ 5 cmH2O.
- Acute respiratory distress syndrome following Berlin definition.
- COVID-19
- PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
- Compliance of the respiratory system < 50 mL/cmH2O
Who cannot join
- Contraindication to prone position.
- Pregnancy.
- Weight < 40 kg
- height < 140 cm or height > 190 cm.
- Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
- Other significant cause than ARDS to the respiratory failure.
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- Decision to limit active therapies.
- No arterial line in place.
- Obesity with weight / height ratio > 1 kg / cm.
- Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global pandemia).
- Severe chronic respiratory failure with oxygen at home.
- Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe chronic cardiac failure).
- History of pneumonectomy or pulmonary lobectomy.
- Patient scheduled for extracorporeal membrane oxygenation.
- Known hypersensibility to Curosurf.
- Contraindication to bronchial fibroscopy.
- Person under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Francois Quesnay
Mantes-la-Jolie
Christophe LENCLUD, MD
Chrstophe LENCLUD, MD
About this study
Official title: Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia
Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
- Conditions
- COVID-19, ARDS, Human
- Being tested
- poractant alfa
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poractant alfaDrug
Patient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total volume will be divided in each of the five lobar bronchi.
| Study group | Role | What they receive |
|---|---|---|
| Surfactant arm | Experimental | patient receiving the surfactant Receives: Drug: poractant alfa |
| Control arm | No intervention | patient not receiving the surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).
Measured: 1 hour post treatment
Secondary outcomes (10)
Oxygenation : PaO2 / FiO2 ratio.
Measured: up to Day 1 and up to Day 7
Oxygenation : area under the PaO2 / FiO2 curve.
Measured: up to Day 1 and up to Day 7
Oxygenation : area under the SpO2 curve.
Measured: up to Hour 1 and up to Hour 24
Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.
Measured: 1 hour
Overall survival rate
Measured: at 28 days, 56 days.
Mortality rate at discharge from the intensive care unit.
Measured: through study completion, an average of 6 months.
Mortality rate at discharge from the hospital.
Measured: through study completion, an average of 6 months.
Number of ventilator-free days
Measured: Day 28, Day 56
Number of prone position sessions.
Measured: up to 56 days
Time between inclusion and the last prone position session.
Measured: up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start29 May 2020
- Primary completion29 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Christophe LENCLUD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Christophe LENCLUD, Versailles Hospital
- Investigators
- Christophe LENCLUD, MD, Principal investigator, Hospital of Mantes-la-Jolie, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384731
- Sponsor's protocol ID
- P20/06
- Acronym
- Caards-1
- Status last verified
- Feb 2021
- First submitted
- 7 May 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia
- ClinicalTrials.gov ID
- NCT04384731
- Acronym / sponsor ID
- Caards-1 / P20/06
- Conditions
- COVID-19, ARDS, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr Christophe LENCLUDUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 29 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 12 May 2020 (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.
Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant arm | Experimental | Drug: poractant alfapatient receiving the surfactant |
| Control arm | No intervention | –patient not receiving the surfactant |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years
- Intensive care unit admission.
- Intubation and mechanical ventilation since less than 72h.
- Positive end-expiratory pressure ≥ 5 cmH2O.
- Acute respiratory distress syndrome following Berlin definition.
Key exclusion criteria (17 listed)
- Contraindication to prone position.
- Pregnancy.
- Weight < 40 kg
- height < 140 cm or height > 190 cm.
- Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
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 |
|---|---|---|
| poractant alfaPatient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total volume will be divided in each of the five lobar bronchi. | Drug | Surfactant arm |
Primary outcome
Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).
Time frame: 1 hour post treatment
10 secondary outcomes
Oxygenation : PaO2 / FiO2 ratio.
Time frame: up to Day 1 and up to Day 7
Oxygenation : area under the PaO2 / FiO2 curve.
Time frame: up to Day 1 and up to Day 7
Oxygenation : area under the SpO2 curve.
Time frame: up to Hour 1 and up to Hour 24
Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.
Time frame: 1 hour
Overall survival rate
Time frame: at 28 days, 56 days.
Mortality rate at discharge from the intensive care unit.
Time frame: through study completion, an average of 6 months.
Mortality rate at discharge from the hospital.
Time frame: through study completion, an average of 6 months.
Number of ventilator-free days
Time frame: Day 28, Day 56
Number of prone position sessions.
Time frame: up to 56 days
Time between inclusion and the last prone position session.
Time frame: up to 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Christophe LENCLUD, MD principal investigator
Hospital of Mantes-la-Jolie, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing poractant alfa in people with COVID-19 and ARDS, Human, run by Dr Christophe LENCLUD at 1 site in France.
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 17 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: status not confirmed, as of the sponsor's last update on 3 Feb 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine ROUX (+33139239777, sroux@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1). (time frame: 1 hour post treatment). 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 3 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.