Status:
TERMINATED
Safety in Convalescent Plasma Transfusion to COVID-19
Lead Sponsor:
TecSalud Investigación Clínica
Collaborating Sponsors:
Tecnologico de Monterrey
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, howe...
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, howe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04333355
Start Date
May 8 2020
End Date
August 20 2020
Last Update
February 10 2021
Active Locations (1)
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1
Hospital San José
Monterrey, Nuevo León, Mexico, 64718