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Trial record 1 of 135 for:    covid-19 convalescent plasma
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Efficacy and Safety of COVID-19 Convalescent Plasma

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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

Tracking Information
First Submitted Date  ICMJE May 20, 2020
First Posted Date  ICMJE May 21, 2020
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • 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.
  • 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.
  • 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.
  • Ventilator free days [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]
    Days without oxygenation support after receiving convalescent plasma
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • 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)
  • Clinical outcome [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of COVID-19 Convalescent Plasma
Official Title  ICMJE Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Convalescent Plasma
  • COVID-19
  • SARS-CoV 2
Intervention  ICMJE Biological: anti-SARS-CoV-2 convalescent plasma
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Study Arms  ICMJE Hospitalized patients with SARS CoV-2 infection
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
Intervention: Biological: anti-SARS-CoV-2 convalescent plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 29, 2021
Estimated Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rada Grubovic Rastvorceva, MD MSci PhD +38923226923 ext 126 drgrubovic@gmail.com
Listed Location Countries  ICMJE North Macedonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04397523
Other Study ID Numbers  ICMJE ITM05/2020MKD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institute for Transfusion Medicine of RNM
Study Sponsor  ICMJE Institute for Transfusion Medicine of RNM
Collaborators  ICMJE University Clinic for Infectious Diseases, North Macedonia
Investigators  ICMJE
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
PRS Account Institute for Transfusion Medicine of RNM
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP