PERUCONPLASMA: EVALUATING THE USE OF CONVALESCENT PLASMA AS MANAGEMENT OF COVID-19

PERUCONPLASMA: RANDOMIZED CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF CONVALESCENT PLASMA IN HOSPITALIZED PATIENTS WITH COVID-19

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-016-20

Enrollment

Registered

2020-06-27

Start date

2020-06-01

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group Type of group

1 to 2 units of 200 ml to 250 ml of COVID-19 convalescent from recovered COVID-19 patients Group name:Control group Type of group

Local standard of care

Eligibility

Inclusion criteria

Inclusion criteria: 􀀀 18 years old or older 􀀀 Hospitalized patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation. 􀀀 Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria: • Respiratory frequency >22 • O2 saturation ≤93% • PaO2 50mmHg o • PaO2/FiO2 <300 Or Critical disease with one or more o the following criteria: • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours • Shock 􀀀 Inform consent signed by patient or direct family member

Exclusion criteria

Exclusion criteria: 􀀀 Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components 􀀀 Multiorgan failure, defined by a SOFA score of >5 􀀀 Hemodinamically unstable, with PA<60 mmH, refractory to the use of vasopressors 􀀀 Uncontroled concomitant infection 􀀀 Disseminated intravascular coagulation 􀀀 Miocardial infarction 􀀀 Acute coronary disease 􀀀 Patient on dialysis 􀀀 Intracranieal bleeding active within last 7 days.

Design outcomes

Primary

Measure	Time frame
Outcome name:rate of development of serious adverse events Measure:Serious adverse events related to transfusion of convalescent plasma Timepoints:6 months	—

Secondary

Measure	Time frame
Outcome name:determination of 30-day mortality rate Measure:all-cause mortality Timepoints:6 months ; Outcome name:Calculation of the median of hospital stay Measure:Hospital length stay Timepoints:6 months ; Outcome name:Median length of ICU stay Measure:Length of ICU stay Timepoints:6 months ; Outcome name:Median time of mechanical ventilation required from the day of enrollment Measure:Length of mechanical ventilation Timepoints:6 months	—

Measure

Time frame

Outcome name:determination of 30-day mortality rate Measure:all-cause mortality Timepoints:6 months ; Outcome name:Calculation of the median of hospital stay Measure:Hospital length stay Timepoints:6 months ; Outcome name:Median length of ICU stay Measure:Length of ICU stay Timepoints:6 months ; Outcome name:Median time of mechanical ventilation required from the day of enrollment Measure:Length of mechanical ventilation Timepoints:6 months

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Countries

Peru

Contacts

Public ContactPatricia Garcia

UNIVERSIDAD PERUANA CAYETANO HEREDIA

patricia.garcia@upch.pe991886872

Outcome results