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Background: The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease, showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown.
Methods: DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 hours before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 hours after randomization, with a second administration of 2 units 24 to 36 hours after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma.
Discussion: This trial will either provide support or discourage the use of convalescent plasma as early intervention for the treatment of hospitalized patients with COVID-19 infection.
Trial registration: Clinicaltrials.gov, Identifier: NCT04429854. Registered 12 June 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04429854.
Keywords
SARS-CoV-2, COVID-19, Convalescent plasma, Antibodies, Immunity
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CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #2 received
Received 03 Nov, 2020
Editorial decision: Accept
On 03 Nov, 2020
Reviewer #2 agreed
On 01 Nov, 2020
Reviewer #1 agreed
On 30 Oct, 2020
Review #1 received
Received 30 Oct, 2020
Reviewers invited
Invitations sent on 28 Oct, 2020
Editor assigned
On 12 Oct, 2020
Submission checks complete
On 11 Oct, 2020
Version 1
Posted 18 Aug, 2020
No comments provided
Editorial decision: Major revision
On 28 Sep, 2020
Review #2 received
Received 27 Sep, 2020
Reviewer #2 agreed
On 29 Aug, 2020
Review #1 received
Received 26 Aug, 2020
Reviewer #1 agreed
On 21 Aug, 2020
Reviewers invited
Invitations sent on 20 Aug, 2020
Editor assigned
On 14 Aug, 2020
Submission checks complete
On 13 Aug, 2020
First submitted
On 06 Aug, 2020
Metrics
Comments: 0
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #2 received
Received 03 Nov, 2020
Editorial decision: Accept
On 03 Nov, 2020
Reviewer #2 agreed
On 01 Nov, 2020
Reviewer #1 agreed
On 30 Oct, 2020
Review #1 received
Received 30 Oct, 2020
Reviewers invited
Invitations sent on 28 Oct, 2020
Editor assigned
On 12 Oct, 2020
Submission checks complete
On 11 Oct, 2020
Version 1
Posted 18 Aug, 2020
No comments provided
Editorial decision: Major revision
On 28 Sep, 2020
Review #2 received
Received 27 Sep, 2020
Reviewer #2 agreed
On 29 Aug, 2020
Review #1 received
Received 26 Aug, 2020
Reviewer #1 agreed
On 21 Aug, 2020
Reviewers invited
Invitations sent on 20 Aug, 2020
Editor assigned
On 14 Aug, 2020
Submission checks complete
On 13 Aug, 2020
First submitted
On 06 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease, showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown.
Methods: DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 hours before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 hours after randomization, with a second administration of 2 units 24 to 36 hours after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma.
Discussion: This trial will either provide support or discourage the use of convalescent plasma as early intervention for the treatment of hospitalized patients with COVID-19 infection.
Trial registration: Clinicaltrials.gov, Identifier: NCT04429854. Registered 12 June 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04429854.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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