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Efficacy and Safety of COVID-19 Convalescent Plasma

Primary Purpose

Convalescent Plasma, COVID-19, SARS-CoV 2

Status
Completed
Phase
Not Applicable
Locations
North Macedonia
Study Type
Interventional
Intervention
anti-SARS-CoV-2 convalescent plasma
Sponsored by
Institute for Transfusion Medicine of RNM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convalescent Plasma focused on measuring COVID-19, anti SARS-CoV-2 convalescent plasma, COVID-19 convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute for Transfusion Medicine of RNM

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hospitalized patients with SARS CoV-2 infection

Arm Description

Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma

Outcomes

Primary Outcome Measures

Duration of oxygenation and ventilation support
The total number of days patients required respiratory support.
Hospital length of stay (LOS)
Total number of days patients were admitted to the hospital.
ICU admission
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Ventilator free days
Days without oxygenation support after receiving convalescent plasma
Incidence of serious adverse events
Cumulation incidence of serious adverse events during the study protocol

Secondary Outcome Measures

Type of respiratory support
Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)
Number of participants with different clinical outcomes including death, critical illness and recovery
Number of participants with different clinical outcomes including death, critical illness and recovery

Full Information

First Posted
May 20, 2020
Last Updated
May 10, 2021
Sponsor
Institute for Transfusion Medicine of RNM
Collaborators
University Clinic for Infectious Diseases, North Macedonia
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1. Study Identification

Unique Protocol Identification Number
NCT04397523
Brief Title
Efficacy and Safety of COVID-19 Convalescent Plasma
Official Title
Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Transfusion Medicine of RNM
Collaborators
University Clinic for Infectious Diseases, North Macedonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convalescent Plasma, COVID-19, SARS-CoV 2
Keywords
COVID-19, anti SARS-CoV-2 convalescent plasma, COVID-19 convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospitalized patients with SARS CoV-2 infection
Arm Type
Other
Arm Description
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
Intervention Type
Biological
Intervention Name(s)
anti-SARS-CoV-2 convalescent plasma
Intervention Description
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Primary Outcome Measure Information:
Title
Duration of oxygenation and ventilation support
Description
The total number of days patients required respiratory support.
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Title
Hospital length of stay (LOS)
Description
Total number of days patients were admitted to the hospital.
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Title
ICU admission
Description
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Title
Ventilator free days
Description
Days without oxygenation support after receiving convalescent plasma
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Title
Incidence of serious adverse events
Description
Cumulation incidence of serious adverse events during the study protocol
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Secondary Outcome Measure Information:
Title
Type of respiratory support
Description
Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)
Time Frame
28 days after transfusion or until hospital discharge (whichever comes first)
Title
Number of participants with different clinical outcomes including death, critical illness and recovery
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Blood donors: Age: >18 and <60 years Body weight : >55 kg Confirmed previous SARS CoV-2 infection Minimum 28 days after the last symptom or finishing of the isolation, or 21 day without symptoms from the date of the negative SARS CoV-2 test Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing. 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) Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies Individuals who meet all regular voluntary donor eligibility requirements Patients/recipients: Age: >18 years Admitted to an acute care facility for the treatment of COVID-19 complications Patients with severe or immediately life-threatening COVID-19, or Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Informed consent provided by the patient or healthcare proxy Exclusion Criteria: Blood donors: Age : <18 or >60 years Female subjects who are pregnant HIV1,2 hepatitis B,C or syphilis infection Donors ineligible for regular voluntary blood donation Patients/recipients: Age : <18 years Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) Patients who received in the past 30 days immunoglobulin therapy Females who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rada Grubovic Rastvorceva, MD MSci PhD
Organizational Affiliation
Institute for Transfusion Medicine of RNM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sedulla Useini, MD
Organizational Affiliation
Institute for Transfusion Medicine of RNM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Transfusion Medicine of RNM
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32113510
Citation
Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
Results Reference
background
PubMed Identifier
32219428
Citation
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Results Reference
background
Citation
Huaxia, (2020). 'China puts 245 COVID-19 patients on convalescent plasma therapy', Xinhua.net, 2 February. Available at: http://www.xinhuanet.com/english/2020-02/28/c_138828177.htm
Results Reference
background
PubMed Identifier
32167489
Citation
Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
Results Reference
background
PubMed Identifier
32219429
Citation
Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.
Results Reference
background
Citation
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-deviceexemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds Accessed on March 30,2020
Results Reference
background
Citation
Guidance on collection, testing, processing, storage, distribution and monitored use. An EU programme of COVID-19 convalescent plasma collection and transfusion. EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, 08 April, 2020
Results Reference
background
Citation
AABB's CCP Collection Protocol - Donor Eligibility, Processing, Labeling and Distribution, 03 April, 2020 http://www.aabb.org/advocacy/regulatorygovernment/Documents/COVID-19-Convalescent-Plasma-Collection.pdf
Results Reference
background
PubMed Identifier
36295001
Citation
Grubovic Rastvorceva RM, Useini S, Stevanovic M, Demiri I, Petkovic E, Franchini M, Focosi D. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial. Life (Basel). 2022 Oct 9;12(10):1565. doi: 10.3390/life12101565.
Results Reference
derived
Links:
URL
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds
Description
Investigational COVID-19 Convalescent Plasma - Emergency INDs - April 03, 2020

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Efficacy and Safety of COVID-19 Convalescent Plasma

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