COVID-19Phase 1/2NCT04390178
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)
A Phase 1/2 study testing SARS-CoV-2 convalescent plasma in people with COVID-19, run by Joakim Dillner at 1 site in Sweden.
Trial summary
There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 10 Apr 2020to 31 Dec 2020
- Phase
- Phase 1/2
- 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
- Age 18 and <81 years
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment
- A negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- Written informed consent after meeting with a study physician and ability and willingness to complete follow up.
Who cannot join
- No matching plasma donor (exact matching in both the ABO system and the Rh system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Disease duration >8 Days
- Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg), breast feeding,
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- History of severe allergic reactions
- Inability to give informed consent
- Significantly compromised immunity.*
- Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.
Read the detailed description
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 convalescent plasma
- Keywords
- COVID-19 convalescent plasma treatment, SARS-CoV-2 infection, Safety, Effectiveness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 convalescent plasmaBiological
Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma treatment | Experimental | All participants will receive a bag of convalescent plasma. The bag volume will be 180-200 ml. The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions. The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines. Receives: Biological: SARS-CoV-2 convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Decrease in progression to requiring non-invasive or invasive ventilation
Measured: 28 days
Secondary outcomes (9)
Adverse events (AE)
Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Measured: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
Time ro resolution of fever and symptoms
Measured daily until discharged from the hospital.
Measured: Until discharged from the hospital, up to 2 months
Clearance of viraemia
SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measured: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
Inflammatory parameter C-reactive protein (CRP)
Time to normalization of inflammatory parameter C-reactive protein (CRP). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Measured: Until discharged from the hospital, up to 2 months
Inflammatory parameter white blood cell count
Time to normalization of inflammatory parameter white blood cell count (WBC). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Measured: Until discharged from the hospital, up to 2 months
Inflammatory parameter haemoglobin (Hb)
Time to normalization of inflammatory parameter haemoglobin (Hb). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Measured: Until discharged from the hospital, up to 2 months
Inflammatory parameter Pro-calcitonin
Time to normalization of inflammatory parameter Pro-calcitonin. Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Measured: Until discharged from the hospital, up to 2 months
Inflammatory parameter Creatine Kinase
Time to normalization of inflammatory parameter Creatine Kinase. Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Measured: Until discharged from the hospital, up to 2 months
Antibody response to SARS-CoV-2
Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measured: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start10 Apr 2020
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open, non-randomised controlled, clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joakim Dillner
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska Institutet, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Joakim Dillner, Karolinska University Hospital
- Investigators
- Johan Ursing, MD, PhD, Principal investigator, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390178
- Sponsor's protocol ID
- CP1
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will be sharing data but data the management plan is being designed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04390178
- Acronym / sponsor ID
- CP1
- Conditions
- COVID-19
- Keywords
- COVID-19 convalescent plasma treatment, SARS-CoV-2 infection, Safety, Effectiveness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joakim DillnerUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska Institutet, Karolinska University Hospital
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 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.
There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.
Detailed description
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open, non-randomised controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma treatment | Experimental | Biological: SARS-CoV-2 convalescent plasmaAll participants will receive a bag of convalescent plasma. The bag volume will be 180-200 ml. The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions. The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and <81 years
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment
- A negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- Written informed consent after meeting with a study physician and ability and willingness to complete follow up.
Key exclusion criteria (10 listed)
- No matching plasma donor (exact matching in both the ABO system and the Rh system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Disease duration >8 Days
- Estimated glomerular filtration rate <60 (kidney failure stage III or more)
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 |
|---|---|---|
| SARS-CoV-2 convalescent plasmaTreatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection | Biological | Convalescent plasma treatment |
Primary outcome
Disease progression
Time frame: 28 days
Decrease in progression to requiring non-invasive or invasive ventilation
9 secondary outcomes
Adverse events (AE)
Time frame: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
Time ro resolution of fever and symptoms
Time frame: Until discharged from the hospital, up to 2 months
Clearance of viraemia
Time frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
Inflammatory parameter C-reactive protein (CRP)
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter white blood cell count
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter haemoglobin (Hb)
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter Pro-calcitonin
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter Creatine Kinase
Time frame: Until discharged from the hospital, up to 2 months
Antibody response to SARS-CoV-2
Time frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Yes. We will be sharing data but data the management plan is being designed.
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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.
Johan Ursing, MD, PhD principal investigator
Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SARS-CoV-2 convalescent plasma in people with COVID-19, run by Joakim Dillner 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Dec 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 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.
What does this combined 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease progression (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 16 Dec 2021.