COVID-19 With Convalescent Plasma

November 3, 2020 updated by: Chun Pan, Southeast University, China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital, Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. > 18 years of age;
  2. laboratory-confirmed diagnosis of COVID-19;
  3. respiratory failure requiring advanced respiratory support (i.e. high flow nasal cannula[HFNC], noninvasive mechanical ventilation [NIV], and invasive mechanical ventilation [IMV]).

Exclusion Criteria:

  • no

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
convalescent plasma therapy group
the patients received convalescent plasma therapy
Biological: convalescent plasma
convalescent plasma was get from the patients who recovery from COVID-19
Control group
the patients with similar situation without convalescent plasma therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
the mortality from ICU admission to 28 days after admission
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 negative conversion rate
Time Frame: up to 60 days
SARS-CoV-2 viral shedding
up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 convalescent plasma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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