Status:
UNKNOWN
Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19
Lead Sponsor:
Universidad Autonoma de Coahuila
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
COVID-19 Pneumonia
Convalescent Plasma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against th...
Detailed Description
The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against th...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Donors):
- Signed informed consent
- At least positive for 1 q-PCR test for SARS-CoV-2
- 14 days of COVID-19 clinical remission
- Positive serologic test for SARS-CoV-2
- Requirements to donate according to NOM-253-SSA1-2012
- To accept sample storing for future study
- Inclusion Criteria (Receptors):
- Signed informed consent provided by the patient, legal guardian or the health provider if not available
- Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients
- At least positive for 1 q-PCR test for SARS-CoV-2
- Patients with COVID-19 defined as severe or critically ill:
- Severe: RF \> 30 bpm, oxygen saturation \<94%, Pa/FiO2 \<301, bilateral lung infiltrates that extends in \>50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory failure (PaO2 \<60 mmHg or SatO2 \<90% with FiO2 \>60%) and septic shock (MAP \<65 mmHg with vasoactive requirement, lactate \> 2 mmol/L and SOFA score \>1)
- Exclusion Criteria:
- Positive pregnancy test
- Patients in lactation
- Informed consent not signed
- Patients involved in other treatment protocols
- Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule drugs)
Exclusion
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04452812
Start Date
July 6 2020
End Date
April 1 2021
Last Update
July 7 2020
Active Locations (1)
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1
Hospital Universitario "Dr. Gonzalo Valdés Valdés"
Saltillo, Coahuila, Mexico, 25000