Status:
COMPLETED
Convalescent Plasma Compared to the Best Available Therapy for the Treatment of SARS-CoV-2 Pneumonia
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Hea...
Detailed Description
Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for the treatment of severely ill and critically ill patient with COVID-19: Patients will be electronically rand...
Eligibility Criteria
Inclusion
- Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
- Vascular access suitable for administration of hemocomponents.
- SARS-CoV-2 positive RT-PCR.
- Negative pregnancy test in case of a woman of reproductive age
- Signing of evidentiary document of informed consent.
- Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
- Subjects who access the storage of biological samples for future examination.
Exclusion
- Respiratory rate \>30 RPM, SO2 \<93%, PaO2/FiO2 \<200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
- New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
- PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- Pregnant or breastfeeding patients.
- Patients that the investigators consider inappropriate to participate in the clinical trial
- Contraindication to transfusion or history of previous severe reaction to blood products.
- Have received any blood products in the last 120 days.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04358783
Start Date
April 27 2020
End Date
May 1 2021
Last Update
May 26 2021
Active Locations (1)
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1
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460