COVID-19 Convalescent Plasma TreatmentNCT04616976
COVID-19 With Convalescent Plasma
An observational study of COVID-19 Convalescent Plasma Treatment, run by Southeast University, China at 1 site in China.
Trial summary
To clarify the effects of convalescent plasma therapy on SARS-CoV-2 negative conversion rate during hospital stay and 28-day mortality of severe and life-threatening COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Convalescent Plasma Treatment
- What is being tested?
- convalescent plasma
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Nov 2020
- Phase
- Observational
- 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
Study population: All adult patients with COVID-19 who were admitted to ICUs of the participating hospitals between January 1 to February 29, 2020 were screened.
Who may be able to join
- > 18 years of age;
- laboratory-confirmed diagnosis of COVID-19;
- respiratory failure requiring advanced respiratory support (i.e. high flow nasal cannula[HFNC], noninvasive mechanical ventilation [NIV], and invasive mechanical ventilation [IMV]).
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Convalescent Plasma Therapy in Management of Critically Ill Patients With COVID-19: a Matched Case-control Study
To clarify the effects of convalescent plasma therapy on SARS-CoV-2 negative conversion rate during hospital stay and 28-day mortality of severe and life-threatening COVID-19 patients.
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Being tested
- convalescent plasma
- Keywords
- convalescent plasma therapy, COVID-19, mortality
- 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
convalescent plasma was get from the patients who recovery from COVID-19
| Study group | Role | What they receive |
|---|---|---|
| convalescent plasma therapy group | the patients received convalescent plasma therapy Receives: Biological: convalescent plasma | |
| Control group | the patients with similar situation without convalescent plasma therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
the mortality from ICU admission to 28 days after admission
Measured: 28 days
Secondary outcomes (1)
SARS-CoV-2 negative conversion rate
SARS-CoV-2 viral shedding
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jan 2020
- Primary completion29 Feb 2020
- Study completion1 Nov 2020
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-19 Convalescent Plasma TreatmentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616976
- Sponsor's protocol ID
- COVID-19 convalescent plasma
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan C, Chen H, Xie J, Huang Y, Yang Y, Du B, Qiu H. The Efficiency of Convalescent Plasma Therapy in the Management of Critically Ill Patients Infected With COVID-19: A Matched Cohort Study. Front Med (Lausanne). 2022 Jun 16;9:822821. doi: 10.3389/fmed.2022.822821. eCollection 2022.
PubMed 35783610
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Convalescent Plasma Therapy in Management of Critically Ill Patients With COVID-19: a Matched Case-control Study
- ClinicalTrials.gov ID
- NCT04616976
- Acronym / sponsor ID
- COVID-19 convalescent plasma
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Keywords
- convalescent plasma therapy, COVID-19, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 5 Nov 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.
To clarify the effects of convalescent plasma therapy on SARS-CoV-2 negative conversion rate during hospital stay and 28-day mortality of severe and life-threatening COVID-19 patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| convalescent plasma therapy group | – | Biological: convalescent plasmathe patients received convalescent plasma therapy |
| Control group | – | –the patients with similar situation without convalescent plasma therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with COVID-19 who were admitted to ICUs of the participating hospitals between January 1 to February 29, 2020 were screened.
Key inclusion criteria (3 listed)
- > 18 years of age;
- laboratory-confirmed diagnosis of COVID-19;
- respiratory failure requiring advanced respiratory support (i.e. high flow nasal cannula[HFNC], noninvasive mechanical ventilation [NIV], and invasive mechanical ventilation [IMV]).
Key exclusion criteria (1 listed)
- no
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 plasmaconvalescent plasma was get from the patients who recovery from COVID-19 | Biological | convalescent plasma therapy group |
Primary outcome
28-day mortality
Time frame: 28 days
the mortality from ICU admission to 28 days after admission
1 secondary outcome
SARS-CoV-2 negative conversion rate
Time frame: up to 60 days
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 5 Nov 2020.
- Derived from this study: PubMed 35783610Pan C, Chen H, Xie J, Huang Y, Yang Y, Du B, Qiu H. The Efficiency of Convalescent Plasma Therapy in the Management of Critically Ill Patients Infected With COVID-19: A Matched Cohort Study. Front Med (Lausanne). 2022 Jun 16;9:822821. doi: 10.3389/fmed.2022.822821. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Convalescent Plasma Treatment, run by Southeast University, China at 1 site in China.
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 3 inclusion and 1 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 5 Nov 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 China. 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?
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?
28-day mortality (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 NCT04616976, 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 5 Nov 2020.