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Efficacy and Safety of COVID-19 Convalescent Plasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397523
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
University Clinic for Infectious Diseases, North Macedonia
Information provided by (Responsible Party):
Institute for Transfusion Medicine of RNM

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

Condition or disease Intervention/treatment Phase
Convalescent Plasma COVID-19 SARS-CoV 2 Biological: anti-SARS-CoV-2 convalescent plasma Not Applicable

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. A plasmapheresis donation will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : April 29, 2021
Estimated Study Completion Date : April 29, 2021
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Ventilator free days [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]
    Days without oxygenation support after receiving convalescent plasma

  5. 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


Secondary Outcome Measures :
  1. 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)

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Blood donors:

  1. Age: >18 and <60 years
  2. Body weight : >60 kg
  3. Confirmed previous SARS CoV-2 infection
  4. Two negative SARS CoV-2 test result
  5. 21 day without symptoms from the second negative SARS CoV2 negative 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397523


Contacts
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Contact: Rada Grubovic Rastvorceva, MD MSci PhD +38923226923 ext 126 drgrubovic@gmail.com

Locations
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North Macedonia
Institute for Transfusion Medicine of RNM Recruiting
Skopje, North Macedonia, 1000
Contact: Rada Grubovic Rastvorceva, MD MSci PhD    +38923226923 ext 126    drgrubovic@gmail.com   
Sponsors and Collaborators
Institute for Transfusion Medicine of RNM
University Clinic for Infectious Diseases, North Macedonia
Investigators
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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
More Information
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Additional Information:

Publications:
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
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
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
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

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Responsible Party: Institute for Transfusion Medicine of RNM
ClinicalTrials.gov Identifier: NCT04397523    
Other Study ID Numbers: ITM05/2020MKD
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute for Transfusion Medicine of RNM:
COVID-19
anti SARS-CoV-2 convalescent plasma
COVID-19 convalescent plasma