A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19 (COVSurf)
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| ClinicalTrials.gov Identifier: NCT04362059 |
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Recruitment Status :
Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : May 28, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Infections | Device: COVSurf Drug Delivery System Other: Standard of Care | Not Applicable |
The hypothesis behind the proposed trial of surfactant therapy for COVID-19 infected patients requiring ventilator support is that endogenous surfactant is dysfunctional. This could be due to decreased concentration of surfactant phospholipid and protein, altered surfactant phospholipid composition, surfactant protein proteolysis and/or oedema protein inhibition of surfactant surface tension function and/or oxidative inactivation of surfactant proteins. Variations of these dysfunctional mechanisms have been reported in a range of lung diseases, including cystic fibrosis and severe asthma, and in child and adult patients with ARDS. Our studies of surfactant metabolism in adult ARDS patients showed altered percentage composition of surfactant PC, with decreased DPPC and increased surface tension-inactive unsaturated species, and decreased concentrations of both total PC and phosphatidylglycerol (PG)
The SARS-CoV-2 virus binds to the angiotensin converting enzyme-2 (ACE2) receptor, which is preferentially expressed in the peripheral lung ATII cells. Consequent viral infection of ATII cells could reduce cell number and impair the capacity of the lungs to synthesise and secrete surfactant. This, however, has not yet been demonstrated empirically in COVID-19 patients. If this is the case, then exogenous surfactant administration to the lungs is potential one treatment option to mitigate disease severity in these patients.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19 |
| Estimated Study Start Date : | June 27, 2020 |
| Estimated Primary Completion Date : | July 27, 2020 |
| Estimated Study Completion Date : | November 2, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Arm
Patients will be administered surfactant via COVSurf Drug Delivery System
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Device: COVSurf Drug Delivery System
Device introduces surfactant to the patients lungs |
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Active Comparator: Control Arm
Patients shall receive regular Standard of Care treatment
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Other: Standard of Care
Standard of care treatment for respiratory illness |
- Oxygenation Improvement [ Time Frame: 3 months ]To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment
- Pulmonary ventilation Improvement [ Time Frame: 3 months ]To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP − PEEP) × PaCO2]/1000 after study treatment.
- Safety Assessment of Frequency and Severity of Adverse Events [ Time Frame: 3 months ]To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 years old
- Confirmed COVID-19 positive by PCR
- Within 24 hours of mechanical ventilation
- Assent or professional assent obtained
Exclusion Criteria:
- Imminent expected death within 24 hours
- Specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage)
- Known or suspected pregnancy
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR < 30)
- Liver failure
- Anticipated transfer to another hospital, which is not a study site within 72 hours.
- Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362059
| Contact: Danny B Pratt | 02381204989 ext 3943 | danny.pratt@uhs.nhs.uk |
| Principal Investigator: | Michael P Grocott, MD | University Hospital Southampton NHS Foundation Trust |
Publications of Results:
| Responsible Party: | University Hospital Southampton NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT04362059 |
| Other Study ID Numbers: |
RHM CRI0399 |
| First Posted: | April 24, 2020 Key Record Dates |
| Last Update Posted: | May 28, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Respiratory Tract Infections Infection Respiratory Tract Diseases |