Efficacy and Safety of COVID-19 Convalescent Plasma

May 10, 2021 updated by: Institute for Transfusion Medicine of RNM

Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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

  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Institute for Transfusion Medicine of RNM

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

Blood donors:

  1. Age: >18 and <60 years
  2. Body weight : >55 kg
  3. Confirmed previous SARS CoV-2 infection
  4. Minimum 28 days after the last symptom or finishing of the isolation, or
  5. 21 day without symptoms from the date of the negative SARS CoV-2 test
  6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
  7. Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
  8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
  9. Individuals who meet all regular voluntary donor eligibility requirements

Patients/recipients:

  1. Age: >18 years
  2. Admitted to an acute care facility for the treatment of COVID-19 complications
  3. Patients with severe or immediately life-threatening COVID-19, or
  4. Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
  5. Informed consent provided by the patient or healthcare proxy

Exclusion Criteria:

Blood donors:

  1. Age : <18 or >60 years
  2. Female subjects who are pregnant
  3. HIV1,2 hepatitis B,C or syphilis infection
  4. Donors ineligible for regular voluntary blood donation

Patients/recipients:

  1. Age : <18 years
  2. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
  3. Patients who received in the past 30 days immunoglobulin therapy
  4. Females who are pregnant or breastfeeding

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Hospitalized patients with SARS CoV-2 infection
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
Biological: anti-SARS-CoV-2 convalescent plasma
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of oxygenation and ventilation support
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
The total number of days patients required respiratory support.
28 days after transfusion or until hospital discharge (whichever comes first)
Hospital length of stay (LOS)
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of days patients were admitted to the hospital.
28 days after transfusion or until hospital discharge (whichever comes first)
ICU admission
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
28 days after transfusion or until hospital discharge (whichever comes first)
Ventilator free days
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Days without oxygenation support after receiving convalescent plasma
28 days after transfusion or until hospital discharge (whichever comes first)
Incidence of serious adverse events
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Cumulation incidence of serious adverse events during the study protocol
28 days after transfusion or until hospital discharge (whichever comes first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of respiratory support
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)
28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants with different clinical outcomes including death, critical illness and recovery
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants with different clinical outcomes including death, critical illness and recovery
28 days after transfusion or until hospital discharge (whichever comes first)

Collaborators and Investigators

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

Sponsor

Institute for Transfusion Medicine of RNM

Collaborators

University Clinic for Infectious Diseases, North Macedonia

Investigators

  • Principal Investigator: Rada Grubovic Rastvorceva, MD MSci PhD, Institute for Transfusion Medicine of RNM
  • Principal Investigator: Sedulla Useini, MD, Institute for Transfusion Medicine of RNM

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

Helpful Links

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)

April 30, 2020

Primary Completion (ACTUAL)

May 10, 2021

Study Completion (ACTUAL)

May 10, 2021

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITM05/2020MKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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