Safety in Convalescent Plasma Transfusion to COVID-19
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Convalescent plasma
Eligibility Criteria
Inclusion Criteria
- Patients 18 years and older
- Confirmed SARS-CoV-2 Infection by RT-PCR.
Serious or life-threatening infection defined as:
Serious:
- Dyspnea
- Respiratory rate greater than or equal to 30 cycles / minute.
- Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.
Life-threatening infection:
- respiratory failure.
- septic shock.
- dysfunction or multiple organ failure.
- Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.
- Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).
Exclusion Criteria:
- Patients with a history of allergic reaction to any type of previous transfusion.
- Heart failure patients at risk of volume overload.
- Patients with a history of chronic kidney failure in the dialysis phase.
- Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
- Any case where the investigator decides that the patient is not suitable for the protocol.
Sites / Locations
- Hospital San José
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COVID-19 patients receiving Convalescent Plasma
Arm Description
Convalescent Plasma from patients who recently recover from COVID-19
Outcomes
Primary Outcome Measures
Side effects
Identify possible adverse effects after the administration of convalescent plasma
Secondary Outcome Measures
Heart Failure
Development of heart failure during convalescent plasma transfusion or after it.
Pulmonary Edema
Development of pulmonary edema during convalescent plasma transfusion or after it.
Allergic Reaction
Development of any allergic reaction during convalescent plasma transfusion or after it.
Viral load of SARS-CoV-2
RT PCR SARS-CoV-2
Viral load of SARS-CoV-2
RT PCR SARS-CoV-2
Full Information
NCT ID
NCT04333355
First Posted
March 31, 2020
Last Updated
February 8, 2021
Sponsor
Hospital San Jose Tec de Monterrey
Collaborators
Tecnologico de Monterrey
1. Study Identification
Unique Protocol Identification Number
NCT04333355
Brief Title
Safety in Convalescent Plasma Transfusion to COVID-19
Official Title
Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
August 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Jose Tec de Monterrey
Collaborators
Tecnologico de Monterrey
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
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
Detailed Description
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.
The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.
Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, SARS-CoV-2, Convalescent plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 patients receiving Convalescent Plasma
Arm Type
Experimental
Arm Description
Convalescent Plasma from patients who recently recover from COVID-19
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Other Intervention Name(s)
Supportive standard care
Intervention Description
Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
Primary Outcome Measure Information:
Title
Side effects
Description
Identify possible adverse effects after the administration of convalescent plasma
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Heart Failure
Description
Development of heart failure during convalescent plasma transfusion or after it.
Time Frame
14 days
Title
Pulmonary Edema
Description
Development of pulmonary edema during convalescent plasma transfusion or after it.
Time Frame
14 days
Title
Allergic Reaction
Description
Development of any allergic reaction during convalescent plasma transfusion or after it.
Time Frame
14 days
Title
Viral load of SARS-CoV-2
Description
RT PCR SARS-CoV-2
Time Frame
48 hrs
Title
Viral load of SARS-CoV-2
Description
RT PCR SARS-CoV-2
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients 18 years and older
Confirmed SARS-CoV-2 Infection by RT-PCR.
Serious or life-threatening infection defined as:
Serious:
Dyspnea
Respiratory rate greater than or equal to 30 cycles / minute.
Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.
Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.
Life-threatening infection:
respiratory failure.
septic shock.
dysfunction or multiple organ failure.
Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.
Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).
Exclusion Criteria:
Patients with a history of allergic reaction to any type of previous transfusion.
Heart failure patients at risk of volume overload.
Patients with a history of chronic kidney failure in the dialysis phase.
Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
Any case where the investigator decides that the patient is not suitable for the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Fe Castilleja-Leal, MD.
Organizational Affiliation
Hospital San José
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San José
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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
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Safety in Convalescent Plasma Transfusion to COVID-19
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