Status:
UNKNOWN
CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19
Lead Sponsor:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Collaborating Sponsors:
SECRETARIA DE SALUD DEL ESTADO DE SONORA
CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ...
Detailed Description
Specific objectives 1. Show the efficacy and safety of fresh plasma in different doses in severe cases and in very severe cases. 2. Assess whether fresh plasma can overcome negative prognostic factor...
Eligibility Criteria
Inclusion
- All patients with COVID-19 test positive and... Severe ill patient
- Respiratory difficulty
- Sat O2 \<93% without O2 but improves with the use of supplemental oxygen
- CT scan image: COVID-19 compatible pneumonia
- one or more of at least: SOFA = 0 D-dimer ≥500 Age ≥ 65 years Comorbidities such as high blood pressure, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, ≥ 1 degree of obesity
- Very severe ill:
- Respiratory difficulty that does not improve with supplemental oxygen, requiring intubation and connecting to ventilatory support of no more than 72hrs or 3 days.
- CT image: COVID-19 compatible pneumonia
- one or more of at least: SOFA ≥1 Dimer D ≥ 750 Age ≥ 65 years Comorbidities such as hypertension, diabetes mellitus type I and II, Chronic Kidney Failure, Controlled or cured cancer, ≥ 1 degree of obesity.
- Survival over 5 days.
- Other inclusion criteria:
- a) Pregnant women are accepted
Exclusion
- patients with asymptomatic/mild disease for COVID-19
- Children less than 16 years old
- patients with atypical pneumonia without COVID-19 diagnostic for PCR-RT
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04356482
Start Date
May 20 2020
End Date
December 1 2020
Last Update
June 5 2020
Active Locations (3)
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1
Hospital Del Issste Regional En Guadalajara Jalisco
Guadalajara, Jalisco, Mexico, 45100
2
Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado
Hermosillo, Sonora, Mexico, 64890
3
Hospital Central Norte Pemex
Mexico City, Mexico, 02720