Severe COVID-19Phase 2IPCONCT04712344
Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO)
A Phase 2 study testing COVID-19 convalescent plasma in people with Severe COVID-19, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe COVID-19
- What is being tested?
- COVID-19 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2021to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged ≥18 years.
- Estimated BMI ≥19kg/m² to ≤40kg/m².
- Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- ARDS with Horovitz index <300mmHg.
- Necessity of invasive mechanical ventilation.
- Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
- Subject's assent if obtainable
Who cannot join
- Previous exposure to COVID-19 convalescent plasma.
- Adverse reaction to plasma proteins in medical history.
- Interval >72h since endotracheal intubation.
- Current or imminent necessity of ECMO treatment.
- Pre-existing COPD GOLD stage 4.
- Chronic congestive heart failure NYHA ≥3.
- Pre-existing left ventricular ejection fraction <30%.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen
Carsten Willam, MD
About this study
Official title: Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
Read the detailed description
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
- Conditions
- Severe COVID-19
- Being tested
- COVID-19 convalescent plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 convalescent plasmaBiological
Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 convalescent plasma | Experimental | A total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment. Receives: Biological: COVID-19 convalescent plasma |
| Standard treatment | No intervention | Standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SOFA score from Baseline Visit
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data. SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets. All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score. The lower the SOFA score, the better is the prognosis (Maximum value 24)
Measured: [Day 1, Visit 2] to Day 8 [Visit 9]
Secondary outcomes (9)
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
Mean number of days without invasive mechanical ventilation during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject.
Time from Baseline Visit [Day 1, Visit 2] to extubation.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
Assessment of mortality during defined time-frame
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
Number of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
Proportion of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
Mean number of days without supplemental oxygen during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
Mean relative change of PEEP from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
Mean relative change of FiO2 from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
Mean relative change of driving pressure from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
Time from Baseline Visit [Day 1, Visit 2] to stop of invasive mechanical ventilation.
Measured: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start18 Jan 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COVID-19Studies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carsten Willam, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712344
- Sponsor's protocol ID
- UKER-COV2-01
- Acronym
- IPCO
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 20 Jan 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04712344
- Acronym / sponsor ID
- IPCO / UKER-COV2-01
- Conditions
- Severe COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 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.
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
Detailed description
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 convalescent plasma | Experimental | Biological: COVID-19 convalescent plasmaA total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment. |
| Standard treatment | No intervention | –Standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subject aged ≥18 years.
- Estimated BMI ≥19kg/m² to ≤40kg/m².
- Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- ARDS with Horovitz index <300mmHg.
- Necessity of invasive mechanical ventilation.
Key exclusion criteria (7 listed)
- Previous exposure to COVID-19 convalescent plasma.
- Adverse reaction to plasma proteins in medical history.
- Interval >72h since endotracheal intubation.
- Current or imminent necessity of ECMO treatment.
- Pre-existing COPD GOLD stage 4.
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 |
|---|---|---|
| COVID-19 convalescent plasmaInfusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment. | Biological | COVID-19 convalescent plasma |
Primary outcome
Change in SOFA score from Baseline Visit
Time frame: [Day 1, Visit 2] to Day 8 [Visit 9]
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data. SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets. All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score. The lower the SOFA score, the better is the prognosis (Maximum value 24)
9 secondary outcomes
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 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.
Carsten Willam, MD principal investigator
University Hospital Erlangen
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 COVID-19 convalescent plasma in people with Severe COVID-19, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 7 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 20 Jan 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 Germany. 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 Mario Schiffer, MD (+49913185 ext. 39002, mario.schiffer@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SOFA score from Baseline Visit (time frame: [Day 1, Visit 2] to Day 8 [Visit 9]). 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 20 Jan 2021.