CoronavirusPhase 2REP-COVIDNCT04374539
Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
A Phase 2 study testing Plasma exchange and Standar medical treatmen in people with Coronavirus, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus
- What is being tested?
- Plasma exchange and Standar medical treatmen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 29 Apr 2020to 29 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject ≥18 years and < 80 years of age;
- Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;
- Subjects admitted in ICU with invasive mechanical ventilation;
- Informed consent granted via telephone by relatives or legal representative
Who cannot join
- More than seven days with invasive mechanical ventilation
- Refractory Shock (Noradrenaline dose > 0.5 micrograms/ kg/minute)
- Decompensated Cirrhosis
- Chronic kidney disease requiring hemodialysis
- Active neoplastic disease
- Severe chronic heart failure (NYHA class III or IV)
- Severe pulmonary disease (GOLD III or IV)
- HIV infection (AIDS criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
Read the detailed description
Plasma exchange (PE) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, with deleterious effects on the function of different organs and systems. The efficacy and safety of PE has been demonstrated in patients with fulminant hepatitis (FH), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. In FH, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. Such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (PAMPs and DAMPs), proinflammatory mediators (cytokines and ROS), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. Several case reports also suggest that PE is an effective rescue therapy in critically ill patients with influenza A (H1N1). However, the efficacy of PE has not been evaluated in critically ill patients with COVID-19 disease.
- Conditions
- Coronavirus
- Being tested
- Plasma exchange, Standar medical treatmen
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchangeBiological
Plasma exchanges with 5% human albumin and fresh frozen plasma in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
Polyclonal immunoglobulin will be administered at a dose of 100 mg / kg ev after each plasma exchange.
Standar Medical treatment Kaletra:
lopinavir/ritonavir: 2c/12h 7 days
- Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days
- Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV)
- Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg)
- Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days
- Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days
- Clexane 40-60 mg/d
Standar medical treatmenDrug
Kaletra: lopinavir/ritonavir: 2c/12h 7 days
- Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days
- Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV)
- Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg)
- Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days
- Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days
- Clexane 40-60 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Plasma exchange | Experimental | Plasma exchange with human serum albumin + Polyclonal immunoglobulin + standard medical treatment Receives: Biological: Plasma exchange |
| Standar medical treatment | Active comparator | Standar medical treatment Receives: Drug: Standar medical treatmen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of plasma exchange
Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.
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 posted5 May 2020
- Study start29 Apr 2020
- Primary completion6 Jun 2021
- Study completion29 Jun 2021
Why it stopped: inability to recruit more patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Model description
- Multicenter open label randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374539
- Sponsor's protocol ID
- 2020-001722-66
- Acronym
- REP-COVID
- Status last verified
- Mar 2022
- First submitted
- 2 May 2020
- Last updated
- 5 Apr 2022
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04374539
- Acronym / sponsor ID
- REP-COVID / 2020-001722-66
- Conditions
- Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to recruit more patients
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 5 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.
Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
Detailed description
Plasma exchange (PE) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, with deleterious effects on the function of different organs and systems. The efficacy and safety of PE has been demonstrated in patients with fulminant hepatitis (FH), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. In FH, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. Such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (PAMPs and DAMPs), proinflammatory mediators (cytokines and ROS), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. Several case reports also suggest that PE is an effective rescue therapy in critically ill patients with influenza A (H1N1). However, the efficacy of PE has not been evaluated in critically ill patients with COVID-19 disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter open label randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Plasma exchange | Experimental | Biological: Plasma exchangePlasma exchange with human serum albumin + Polyclonal immunoglobulin + standard medical treatment |
| Standar medical treatment | Active comparator | Drug: Standar medical treatmenStandar medical treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject ≥18 years and < 80 years of age;
- Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;
- Subjects admitted in ICU with invasive mechanical ventilation;
- Informed consent granted via telephone by relatives or legal representative
Key exclusion criteria (8 listed)
- More than seven days with invasive mechanical ventilation
- Refractory Shock (Noradrenaline dose > 0.5 micrograms/ kg/minute)
- Decompensated Cirrhosis
- Chronic kidney disease requiring hemodialysis
- Active neoplastic disease
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 |
|---|---|---|
| Plasma exchangePlasma exchanges with 5% human albumin and fresh frozen plasma in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit. Polyclonal immunoglobulin will be administered at a dose of 100 mg / kg ev after each plasma exchange. Standar Medical treatment Kaletra: lopinavir/ritonavir: 2c/12h 7 days * Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days * Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV) * Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg) * Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days * Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days * Clexane 40-60 mg/d | Biological | Plasma exchange |
| Standar medical treatmenKaletra: lopinavir/ritonavir: 2c/12h 7 days * Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days * Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV) * Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg) * Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days * Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days * Clexane 40-60 mg/d | Drug | Standar medical treatment |
Primary outcome
Impact of plasma exchange
Time frame: 28 days
Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.
Results and safety
The study was stopped early (reason given: inability to recruit more patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Plasma exchange and Standar medical treatmen in people with Coronavirus, run by Fundacion Clinic per a la Recerca Biomédica 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 Apr 2022. 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 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?
The study was stopped early (reason given: inability to recruit more patients). Results are not available in the source record.
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?
Impact of plasma exchange (time frame: 28 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 5 Apr 2022.