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Covid19Phase 2/3NCT04649879

Convalescent Plasma for Treatment of COVID-19

A Phase 2/3 study testing SARS-CoV-2 convalescent plasma in people with Covid19, run by Joakim Dillner at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
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
59 participants
Where
3 sitesSweden
Study dates
3 Dec 2020to 26 Jan 2022
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

  • Age greater than or equal to 18
  • Admitted to a study hospital
  • Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples and blood
  • 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 the ABO system is required)
  • Unavailability of plasma
  • Estimated glomerular filtration rate <30 (kidney failure stage III or more)
  • Pregnancy (urinary-hcg)
  • Breast feeding
  • Inability to give informed consent

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Department of Infectious Disease, Falu Hospital

    Falun, Dalarn, 79182

  • Department of Geriatrics, Karolinska University Hospital

    Stockholm, 171 76

  • Danderyd Hospital

    Stockholm, 18257

Other trials in Sweden

About this study

Official title: Convalescent Plasma for Treatment of COVID-19: An Open Randomised Controlled Trial

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).

Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.

Conditions
Covid19
Being tested
SARS-CoV-2 convalescent plasma, Standard of care
Keywords
COVID-19 convalescent plasma treatment, SARS-CoV-2 infection, Viremia
Medical subject headings
COVID-19, Viremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 convalescent plasmaBiological

    Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. CP will be given as a slow infusion over 2 hours. CP neutralization titre of ≥ 1/640 or an ELISA reactivity against the Spike protein of SARS-CoV-2 by the Euroimmun commercial assay >9 is desired. New antibody tests are under development and can be used instead if equivalence to neutralization or Euroimmun ELISA is demonstrated.

  • Standard of careOther

    Standard of care as determined by hospital practices for COVID-19 patients.

Study groups in NCT04649879
Study groupRoleWhat they receive
Convalescent plasma treatmentExperimental* Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. * If steroid therapy has not already been initiated, betamethasone 3 mg daily will be given concomitantly with steroid therapy or longer if clinically indicated but for a maximum of 10 days.
Receives: Biological: SARS-CoV-2 convalescent plasma
ControlActive comparatorStandard of care for COVID-19 patients.
Receives: Other: Standard of care

What is being measured

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

  1. COVID-19 related mortality within 28 days

    Death of a study participant within 28 days.

    Measured: Measured 28 days after inclusion into the study.

Secondary outcomes (5)

  1. COVID-19 related mortality within 60 days

    Death of a study participant within 60 days.

    Measured: Measured 60 days after inclusion into the study.

  2. Requirement of invasive ventilation or Pao2/FiO2 ≤ 70 for ≥ 12 hours in the case of patients not eligible for intensive care

    • The need for mechanical ventilation and date when this was initiated
    • For patients not eligible for intensive care: each day when PaO2/FiO2 ratio was less than 70 for ≥ 12 hours. PaO2 and FiO2 will be estimated from SO2% and O2 flow in nasal cannula, face mask or face mask with reservoir based on EPIC II data. A ratio of 70 is approximately equal to 90% SO2 with 8-9 L of Oxygen flow using a face mask with a reservoir.

    Measured: Until discharged from the hospital, up to 2 months

  3. Adverse events

    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.

  4. Dose of plasma needed to clear viremia

    Measured as doses of convalescent plasma administered (1-10 infusions, 200ml).

    Measured: 28 days

  5. Time to clearance of viremia

    Blood samples for detection of SARS-CoV-2 in the blood will be taken prior to treatment start, daily during treatment and until two consecutive negative results are obtained.

    Measured: Until discharged from the hospital, up to 2 months

Timeline

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

  1. First posted2 Dec 2020
  2. Study start3 Dec 2020
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

Resources

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
Patients will be randomised 2:1 to treatment with convalescent plasma and standard of care only. Randomisation is by random permutated blocks using Redcap or equivalent.
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649879
Sponsor's protocol ID
CP3
Status last verified
Jan 2022
First submitted
1 Dec 2020
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will be sharing the data, but the management plan is being designed.

Publications

  • Dillner J, Ursing J. Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden. BMJ Open. 2021 Dec 8;11(12):e048337. doi: 10.1136/bmjopen-2020-048337.

    PubMed 34880010

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SARS-CoV-2 convalescent plasma in people with Covid19, run by Joakim Dillner at 3 sites 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 6 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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 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?

COVID-19 related mortality within 28 days (time frame: Measured 28 days after inclusion into the study.). 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 NCT04649879, 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 9 Feb 2022.

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