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

Universidad del Rosario

Status and phase: Completed; Phase 2

Conditions: Coronavirus Infection; Coronavirus

Treatments: Drug: Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04332380

ABN011-1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Fulfilling all the following 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Intervention Group

Experimental group

Description:

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.

Treatment:

Drug: Plasma