Convalescent Plasma for Patients With COVID-19: A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-07-28

Brief Summary

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Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

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Detailed Description

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The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Conditions

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Coronavirus Coronavirus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol.

Group Type EXPERIMENTAL

Plasma

Intervention Type DRUG

Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.

Interventions

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Plasma

Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.

Intervention Type DRUG

Other Intervention Names

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Convalescent Plasma COVID-19

Eligibility Criteria

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Inclusion Criteria

1. Aged between 18 and 60 years, male or female.
2. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.
3. Without treatment.
4. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".
5. Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) \>= 2.
6. Sequential Organ Failure Assessment score (SOFA) \< 6.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Female subjects who are pregnant or breastfeeding.
2. Patients with prior allergic reactions to transfusions.
3. Critical ill patients in intensive care units.
4. Patients with surgical procedures in the last 30 days.
5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
6. HIV diagnosed patients with viral failure (detectable viral load\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
7. Patients who have suspicion or evidence of coinfections.
8. End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
9. Child Pugh C stage liver cirrhosis.
10. High cardiac output diseases.
11. Autoimmune diseases or Immunoglobulin A nephropathy.
12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No