COVID-19Phase 1NCT04592705
Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
A Phase 1 study testing Therapeutic plasma exchange in people with COVID-19, run by Larkin Community Hospital at 1 site in United States.
Trial summary
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Therapeutic plasma exchange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2020to 30 Aug 2021
- Phase
- Phase 1
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
- Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
- Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
- Subjects between 18 and 69 years of age.
- If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
- A positive COVID-19 test via nasopharyngeal swab RT-PCR.
- Agree to not participate in another clinical trial during the study period.
Who cannot join
- Under 18 years of age or older than 69 years of age.
- Severe disease, defined as:
- dyspnea ii. respiratory frequency ≥ 30/min iii. blood oxygen saturation ≤ 93% iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours;
- Life-threatening disease, defined as:
- respiratory failure ii. septic shock, and/or iii. multiple organ dysfunction or failure
- Unable to provide informed consent or decline to consent.
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- Sequential Organ Failure Assessment (SOFA) score of 12 or above.
- Hemodynamic instability, sepsis, or other conditions causing inability to tolerate fluid shifts
- Inability to tolerate central line placement
- Allergy to FFP or albumin
- Severe hypocalcemia
- Patients with heparin allergies should not receive heparin as an anticoagulant during plasmapheresis
- Patients taking angiotensin-converting enzyme (ACE) inhibitors are advised to stop taking the medication for at least 24 hours before starting plasmapheresis
- Active or recent bleeding (unless controlled for >48 hours).
- Thrombocytopenia (≤25,000/L).
- Advanced cirrhosis with a history of esophageal varices.
- Chronic kidney disease requiring hemodialysis.
- Active solid or non-solid malignancy or Lymphoma within the last 2 years.
- Heart failure (NYHA class III or IV).
- HIV infection (AIDS criteria), a history of immunodeficiency, or subject is currently receiving immunosuppressive therapy.
- Women of childbearing age who are pregnant or intend to become pregnant during the study period.
- Known history of chromosomal or genetic abnormalities.
- History of hypersensitivity or any kind of adverse reaction to blood products.
- Contraindication to transfusion of blood products, or refusal due to religious/personal reasons.
- Any kind of drug or alcohol dependence that would interfere with adherence to the study requirements.
- Already part of this trial, recruited at a different hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Larkin Community Hospital
South Miami, Florida, 33143
Michael Talalaev, D.O., 305-284-7500, MTalalaev@larkinhospital.com
About this study
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. The goal of this trial is to study the efficacy and safety of TPE therapy in subjects with moderate to severe COVID-19 by determining the morbidity and mortality after TPE therapy.
- Conditions
- COVID-19
- Being tested
- Therapeutic plasma exchange
- Keywords
- therapeutic plasma exchange, covid19, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeDevice
TPE is the process of plasmapheresis, an invasive procedure separating plasma from red blood cells using centrifuge-based devices.
Filtration involves the insertion of a central venous catheter in the internal jugular, femoral or subclavian vein after which blood is drawn from the patient's circulation and transferred to a filter that separates the plasma from blood cells. Thereafter, the plasma extracted is substituted with human albumin and/or FFP.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic plasma exchange | Experimental | Not described Receives: Device: Therapeutic plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical status downgrade or discharge.
Clinical improvement will be defined as a point reduction in subjects' clinical status on the 8-point WHO ordinal scale for clinical improvement or discharge from the hospital, whichever comes first.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start11 Sep 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 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 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larkin Community Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Talalaev, M.D., D.O., Larkin Community Hospital
- Investigators
- Michael Talalaev, D.O., Principal investigator, Larkin Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592705
- Sponsor's protocol ID
- LCH-1-092020
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04592705
- Acronym / sponsor ID
- LCH-1-092020
- Conditions
- COVID-19
- Keywords
- therapeutic plasma exchange, covid19, coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Larkin Community HospitalUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 19 Oct 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.
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. The goal of this trial is to study the efficacy and safety of TPE therapy in subjects with moderate to severe COVID-19 by determining the morbidity and mortality after TPE therapy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic plasma exchange | Experimental | Device: Therapeutic plasma exchange |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
- Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
- Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
- Subjects between 18 and 69 years of age.
- If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
Key exclusion criteria (26 listed)
- Under 18 years of age or older than 69 years of age.
- Severe disease, defined as:
- Life-threatening disease, defined as:
- Unable to provide informed consent or decline to consent.
- Sequential Organ Failure Assessment (SOFA) score of 12 or above.
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 |
|---|---|---|
| Therapeutic plasma exchangeTPE is the process of plasmapheresis, an invasive procedure separating plasma from red blood cells using centrifuge-based devices. Filtration involves the insertion of a central venous catheter in the internal jugular, femoral or subclavian vein after which blood is drawn from the patient's circulation and transferred to a filter that separates the plasma from blood cells. Thereafter, the plasma extracted is substituted with human albumin and/or FFP. | Device | Therapeutic plasma exchange |
Primary outcome
Time to clinical status downgrade or discharge.
Time frame: 60 days
Clinical improvement will be defined as a point reduction in subjects' clinical status on the 8-point WHO ordinal scale for clinical improvement or discharge from the hospital, whichever comes first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Michael Talalaev, D.O. principal investigator
Larkin Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Therapeutic plasma exchange in people with COVID-19, run by Larkin Community Hospital at 1 site in United States.
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 7 inclusion and 26 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 19 Oct 2020. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Michael Talalaev, D.O. (305-284-7500, MTalalaev@larkinhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical status downgrade or discharge. (time frame: 60 days). 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 19 Oct 2020.