Covid-19COP20NCT04600440
Convalescent Plasma in the Treatment of Covid-19
A study testing Convalescent plasma in people with Covid-19 and Respiratory Insufficiency, run by Skane University Hospital at 1 site in Sweden.
Trial summary
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment. Primary outcome is number of days the patients need oxygen within 28 days from inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Respiratory Insufficiency
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 25 Apr 2020to 28 Feb 2022
- Phase
- Interventional
- 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
- Verified diagnosis of Covid-19
- <94% oxygen saturation
- willingness to participate
- ability to sign informed consent
Who cannot join
- unability to understand information and sign informed consent
- immunosuppressed patient
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, SE-22185
Mona Landin-Olsson, MD, Prof, +4646171000 ext. 71452, mona.landin-olsson@med.lu.se
Magnus Rasmussen, MD, Prof, +4646171000, magnus.rasmussen@med.lu.se
About this study
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment.
Primary outcome is number of days the patients need oxygen within 28 days from inclusion.
Secondary outcome is number of days in hospital, number of days in respirator and mortality.
Side effects of treatment is monitored.
Read the detailed description
Subjects with previous verified COVID-19 are asked to donate plasma 14 days or later after recovery. IgG antibodies against Covid-19 are measured and only subjects with high titers are accepted. Plasmaphereses is done and up to 600 ml plasma is drawn and aliquoted in 200 ml portions.
Patients with acute respiratory symptoms, verified Covid-19, hospitalized and in need of oxygen treatment are asked to participate in the study. The patients are randomized 50/50 to get either convalescent plasma or routine treatment without plasma. The patients randomized to get plasma will have infusion of 200 ml blood group compatible convalescent plasma daily during three days from different donors.
The clinical course will be carefully monitored and days with oxygen requirement will be compared between the groups. Secondary clinical outcomes as mortality, need of assisted ventilation, total days in hospital and side effects to treatment will be observed.
- Conditions
- Covid-19, Respiratory Insufficiency
- Being tested
- Convalescent plasma
- Keywords
- Covid-19, Convalescent plasma
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent plasmaBiological
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
| Study group | Role | What they receive |
|---|---|---|
| Plasma treatment | Experimental | Convalescent plasma 200 ml daily during three days Receives: Biological: Convalescent plasma |
| No plasma | No intervention | Best conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days in need of oxygen
Number of days in need of oxygen within 28 days from inclusion
Measured: 28 days
Secondary outcomes (3)
Number of days before discharge from hospital
number of days before discharge from hospital
Measured: 3 months
Mortality within 3 months
death of patient
Measured: 3 months
Number of days before need of assisted ventilation
number of days before need of assisted 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 posted23 Oct 2020
- Study start25 Apr 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Landin-Olsson, Skane University Hospital
- Investigators
- Mona Landin-Olsson, MD, Prof, Principal investigator, Skane University HospitalMaria N Lundgren, MD, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600440
- Sponsor's protocol ID
- Covid convalescent plasma
- Acronym
- COP20
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holm K, Lundgren MN, Kjeldsen-Kragh J, Ljungquist O, Bottiger B, Wiken C, Oberg J, Fernstrom N, Rosendal E, Overby AK, Wigren Bystrom J, Forsell M, Landin-Olsson M, Rasmussen M. Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden. BMC Res Notes. 2021 Dec 4;14(1):440. doi: 10.1186/s13104-021-05847-7.
PubMed 34863304
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma in the Treatment of Covid-19
- ClinicalTrials.gov ID
- NCT04600440
- Acronym / sponsor ID
- COP20 / Covid convalescent plasma
- Conditions
- Covid-19, Respiratory Insufficiency
- Keywords
- Covid-19, Convalescent plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 23 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.
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment.
Primary outcome is number of days the patients need oxygen within 28 days from inclusion.
Secondary outcome is number of days in hospital, number of days in respirator and mortality.
Side effects of treatment is monitored.
Detailed description
Subjects with previous verified COVID-19 are asked to donate plasma 14 days or later after recovery. IgG antibodies against Covid-19 are measured and only subjects with high titers are accepted. Plasmaphereses is done and up to 600 ml plasma is drawn and aliquoted in 200 ml portions.
Patients with acute respiratory symptoms, verified Covid-19, hospitalized and in need of oxygen treatment are asked to participate in the study. The patients are randomized 50/50 to get either convalescent plasma or routine treatment without plasma. The patients randomized to get plasma will have infusion of 200 ml blood group compatible convalescent plasma daily during three days from different donors.
The clinical course will be carefully monitored and days with oxygen requirement will be compared between the groups. Secondary clinical outcomes as mortality, need of assisted ventilation, total days in hospital and side effects to treatment will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Plasma treatment | Experimental | Biological: Convalescent plasmaConvalescent plasma 200 ml daily during three days |
| No plasma | No intervention | –Best conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Verified diagnosis of Covid-19
- <94% oxygen saturation
- willingness to participate
- ability to sign informed consent
Key exclusion criteria (2 listed)
- unability to understand information and sign informed consent
- immunosuppressed patient
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 plasmaPlasma donated from patients recovered from Covid-19 and having high titres of antibodies | Biological | Plasma treatment |
Primary outcome
Number of days in need of oxygen
Time frame: 28 days
Number of days in need of oxygen within 28 days from inclusion
3 secondary outcomes
Number of days before discharge from hospital
Time frame: 3 months
Mortality within 3 months
Time frame: 3 months
Number of days before need of assisted ventilation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34863304Holm K, Lundgren MN, Kjeldsen-Kragh J, Ljungquist O, Bottiger B, Wiken C, Oberg J, Fernstrom N, Rosendal E, Overby AK, Wigren Bystrom J, Forsell M, Landin-Olsson M, Rasmussen M. Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden. BMC Res Notes. 2021 Dec 4;14(1):440. doi: 10.1186/s13104-021-05847-7.
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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.
Mona Landin-Olsson, MD, Prof principal investigator
Skane University Hospital
Maria N Lundgren, MD study chair
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convalescent plasma in people with Covid-19 and Respiratory Insufficiency, run by Skane University Hospital at 1 site in Sweden.
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 2 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 23 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 Sweden. 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.
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 Magnus Rasmussen, MD, Prof (+4646171000, magnus.rasmussen@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days in need of oxygen (time frame: 28 days). 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 NCT04600440, which also lists 1 linked publication.
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 23 Oct 2020.