COVID-19Phase 2/3ConCoVid-19NCT04342182

Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)

A Phase 2/3 study testing Convalescent plasma in people with COVID-19, run by Erasmus Medical Center at 18 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Passive immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious diseases. Immunoglobulins are used for the treatment of CMV disease, and is effective as prophylaxis when given soon after exposure to varicella zoster virus, rabies, and hepatitis B virus. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Convalescent plasma
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 18 sitesNetherlands
Study dates: 8 Apr 2020to 30 Sep 2020
Phase: Phase 2/3
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

Patients with PCR confirmed COVID disease
Admitted to the hospital
The most recent PCR positive sample is <96hrs old
Written informed consent by patient or legal patient representative
Age at least 18 years

Who cannot join

Participation in another intervention trial on the treatment of COVID-19 that falls under the Dutch law human research (WMO) and in which individual patients are randomized to different treatment options
Known IgA deficiency
Invasive ventilation for already >96 hours
Donors: Eligibility for plasma donation
Inclusions Criteria:
A history of COVID infection that was documented by PCR

Show all 21Show fewer

Known ABO-Resus(D) blood group
A screening for irregular antibodies with a titer ≤ 1:32
Asymptomatic for at least 14 days
Written informed consent regarding the plasmapheresis procedure
Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
Age <18 years and > 65 years
Weight <50kg
Medical history of heart failure
History of transfusion with red blood cells, platelets or plasma
History of organ- or tissue transplant
A cumulative stay in the United Kingdom of ≥ 6 months in the period between 01-01-1980 and 31-12-1996
A history of i.v. drug use
Insulin dependent diabetes
An underlying severe chronic illness (i.e. history of heart failure, cancer or stroke)
Tested positive for HLA- or HNA-antibodies

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Netherlands18 sites

NoordWest Ziekenhuisgroep
Alkmaar
Onze Lieve Vrouwen Gasthuis
Amsterdam
Rijnstate Ziekenhuis
Arnhem
Reinier de Graaf Gasthuis
Delft
Catharina Ziekenhuis
Eindhoven
Medisch Spectrum Twente
Enschede
Groene Hart Ziekenhuis
Gouda
Martini Hospital
Groningen
Spaarna Gasthuis
Haarlem
Alrijne Ziekenhuis
Leiderdorp
Sint Antonius Ziekenhuis
Nieuwegein
Canisius-Wilhelmina Hospital
Nijmegen
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
Maasstad Ziekenhuis
Rotterdam
ZorgSaam Hospital
Terneuzen
Haaglanden Medisch Centrum
The Hague
Bernhoven Hospital
Uden
VieCuri
Venlo

Other trials in Netherlands

About this study

Official title: Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19

Neutralizing antibodies against MERS, SARS-CoV-1 and SARS-CoV-2 have been shown to be present in patients previously infected with MERS, SARS-CoV-1 and SARS-CoV-2 respectively. During the 2003 SARS outbreak in Hong-Kong,a non-randomized study in hospitalized SARS patients showed that treatment with convalescent plasma (convP) from SARS-recovered donors significantly increased the day 22 discharge rate and decreased mortality. A study in non-human primates showed that rhesus macaques could not be re-infected with SARS-CoV-2 after primary infection.

With no proven effective therapy against COVID, this study will evaluate the safety and efficacy of convalescent plasma from COVID-recovered donors as a treatment for hospitalized patients with symptomatic COVID-19. The study will focus on patients who tested positive for SARS-CoV-2 in the last 96 hours before inclusion

Primary objectives

Decrease overall mortality in patients within COVID disease

Study design:

This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care.

Patient population:

Patients with PCR confirmed COVID disease, age >18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days.

Intervention: 300mL of convP Duration of treatment: ConvP will be given as a one-time infusion Duration of follow up: For the primary endpoint: until discharge or death before day 60, whichever comes first. For the secondary endpoints (with separate consent) up to 1 year.

Target number of patients: 426 Target number of donors: 100 Expected duration of accrural: 36 months

Read the detailed description

Secondary (exploratory) objectives

Evaluate the effect of 300ml convP on hospital stay
Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 and 30
Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) <80
Evaluate the effect of 300ml convP on mortality in patients admitted to the ICU
Evaluate the effect of 300ml plasma therapy on hospital days for patients admitted to the ICU within 24 hours after admission
Evaluate the impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
Evaluate the difference in effect of convP on mortality in patients with a duration of symptoms < or > the median duration of symptoms in the study population
Evaluate the impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
Safety of convP therapy
Evaluate the impact of covP on long-term lung function

Conditions: COVID-19
Being tested: 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.

Convalescent plasmaBiological
Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.
Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products

Study groups in NCT04342182
Study group	Role	What they receive
Convalescent plasma	Experimental	Standard of care plus 300mL of convalescent plasma from COVID-19 recovered donors Receives: Biological: Convalescent plasma
Standard of care	No intervention	standard of care (supportive care, oxygen, antibiotics)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first
the mortality in the 300ml convP group will be compared with the control arm
Measured: until hospital discharge or a maximum of 60 days whichever comes first

Secondary outcomes (12)

Impact of 300ml convP therapy on hospital days
the hospital days in the 300ml convP group will be compared with the control arm
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on weaning from oxygen therapy
A patient will be considered weaned from oxygen therapy when the patient did not receive oxygen for at least 24 hours.
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on overall mortality in patients admitted to the ICU within 24 hours after admission
the overall mortality in hospital days in patients admitted tot the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Difference in the effect of convP on mortality in patients with a duration of symptoms less or more the median duration of symptoms in the study population
The mortality in patients with a duration of symptoms less than the median duration of symptoms in the study population will be compared with the mortality in patients with a duration of symptoms more than the median duration of symptoms in the study population
Measured: hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP therapy on ICU days in patients admitted to the ICU within 24 hours after admission
the ICU days in hospital days in patients admitted to the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Measured: Until hospital discharge, estimated average 4 weeks
Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
airway samples will be taken on day 1 - 3 - 5 - 7 - 10 - 14 - and at discharge
Measured: until hospital discharge, estimated average 2 weeks
Impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
Blood wil be drawn at day 1, day 7 and day 14
Measured: until hospital discharge, extimated average 2 weeks
Safety of convP therapy
Evaluation of Severe Adverse Events and transfusion related adverse events
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Change of the 8-point WHO COVID19 disease severity scale on day 15
The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1
Measured: until day 15
Change of the 8-point WHO COVID19 disease severity scale on day 30
The WHO COVID19 disease severity scale on day 30 will be compared with the WHO COVID19 disease severity scale on day 1 and day 15
Measured: until day 30
Change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) <80.
The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1 in patients with a baseline neutralizing antibody titer (PRNT50) <80.
Measured: until day 15
Impact of plasma therapy on risk of long-term structural lung damage and lung function
Low dose CT and lung function is done 6 weeks after discharge and if abnormal again 3 months after discharge.
Measured: up to 12 months after plasma transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202030 Sep 2020

First posted10 Apr 2020
Study start8 Apr 2020
Primary completion1 Jul 2020
Study completion30 Sep 2020

Why it stopped: new insights into COVID19 pathogenesis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP versus the standard of care.
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04342182
Sponsor's protocol ID: NL73489.078.20
Acronym: ConCoVid-19
Status last verified: Mar 2022
First submitted: 31 Mar 2020
Last updated: 1 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
PubMed 37162745
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
PubMed 36734509
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
PubMed 34013969
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
PubMed 33044747

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19
ClinicalTrials.gov ID: NCT04342182
Acronym / sponsor ID: ConCoVid-19 / NL73489.078.20
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: new insights into COVID19 pathogenesis
Enrolment: 86 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Collaborators: Prothya Biosolutions
Study start: 8 Apr 2020 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 10 Apr 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.

Primary objectives

Decrease overall mortality in patients within COVID disease

Study design:

This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care.

Patient population:

Patients with PCR confirmed COVID disease, age >18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days.

Target number of patients: 426 Target number of donors: 100 Expected duration of accrural: 36 months

Detailed description

Secondary (exploratory) objectives

Evaluate the effect of 300ml convP on hospital stay
Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 and 30
Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) <80
Evaluate the effect of 300ml convP on mortality in patients admitted to the ICU
Evaluate the effect of 300ml plasma therapy on hospital days for patients admitted to the ICU within 24 hours after admission
Evaluate the impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
Evaluate the difference in effect of convP on mortality in patients with a duration of symptoms < or > the median duration of symptoms in the study population
Evaluate the impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
Safety of convP therapy
Evaluate the impact of covP on long-term lung function

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP versus the standard of care.

Arm	Type	Receives
Convalescent plasma	Experimental	Biological: Convalescent plasmaStandard of care plus 300mL of convalescent plasma from COVID-19 recovered donors
Standard of care	No intervention	–standard of care (supportive care, oxygen, antibiotics)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with PCR confirmed COVID disease
Admitted to the hospital
The most recent PCR positive sample is <96hrs old
Written informed consent by patient or legal patient representative
Age at least 18 years

Key exclusion criteria (21 listed)

Participation in another intervention trial on the treatment of COVID-19 that falls under the Dutch law human research (WMO) and in which individual patients are randomized to different treatment options
Known IgA deficiency
Invasive ventilation for already >96 hours
Donors: Eligibility for plasma donation
A history of COVID infection that was documented by PCR

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
Convalescent plasmaInfusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID. Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products	Biological	Convalescent plasma

Primary outcome

Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
the mortality in the 300ml convP group will be compared with the control arm

12 secondary outcomes

Impact of 300ml convP therapy on hospital days
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on weaning from oxygen therapy
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on overall mortality in patients admitted to the ICU within 24 hours after admission
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Difference in the effect of convP on mortality in patients with a duration of symptoms less or more the median duration of symptoms in the study population
Time frame: hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP therapy on ICU days in patients admitted to the ICU within 24 hours after admission
Time frame: Until hospital discharge, estimated average 4 weeks
Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
Time frame: until hospital discharge, estimated average 2 weeks
Impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
Time frame: until hospital discharge, extimated average 2 weeks
Safety of convP therapy
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Change of the 8-point WHO COVID19 disease severity scale on day 15
Time frame: until day 15
Change of the 8-point WHO COVID19 disease severity scale on day 30
Time frame: until day 30
Change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) <80.
Time frame: until day 15
Impact of plasma therapy on risk of long-term structural lung damage and lung function
Time frame: up to 12 months after plasma transfusion

Results and safety

The study was stopped early (reason given: new insights into COVID19 pathogenesis). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Derived from this study: PubMed 37162745Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
Derived from this study: PubMed 36734509Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
Derived from this study: PubMed 34013969Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Derived from this study: PubMed 33044747Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

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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.

Bart Rijnders, MD, PhD principal investigator

Erasmus Medical Center

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Convalescent plasma in people with COVID-19, run by Erasmus Medical Center at 18 sites in Netherlands.

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 5 inclusion and 21 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 1 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 18 sites in Netherlands. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: new insights into COVID19 pathogenesis). 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?

Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first (time frame: until hospital discharge or a maximum of 60 days whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342182, which also lists 4 linked publications.

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 1 Apr 2022.