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

• Status: Completed
• Trial end date: 2020-07-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad del Rosario
• Collaborators: CES University; Fundación Universitaria de Ciencias de la Salud; Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud

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.