Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Phase 2

Completed

• Conditions: Coronavirus; Coronavirus Infection
• Interventions: Drug: Standard Therapy; Drug: Plasma

• Registration Number: NCT04332835
• Lead Sponsor: Universidad del Rosario

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Study Start: 2020-08-08
• Primary Completion: 2020-10-31
• Status Verified: 2020-11
• Study Completion: 2020-11-15
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Fulfilling all the following criteria

1. Olerder than 18.
2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
4. Sequential Organ Failure Assessment score (SOFA) < 6.
5. 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 with requierment of Invasive Mechanical Venitlation.
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. Demonstrated coinfection that explains the patient's symptoms
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Therapy	Participants included in the control group will receive standard therapy defined by institutional protocol.
Intervention Group	Plasma	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. Simultaneously, they will receive the standard therapy defined by institutional protocol.
Intervention Group	Standard Therapy	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. Simultaneously, they will receive the standard therapy defined by institutional protocol.

Primary Outcome Measures

Name	Time	Method
Change in Viral Load	Days 0, 4, 7, 14 and 28	Copies of COVID-19 per ml
Change in Immunoglobulin G COVID-19 Titers	Days 0, 4, 7, 14 and 28	Immunoglobulin G COVID-19 antibodies

Secondary Outcome Measures

Name	Time	Method
Mortality	Days 7, 14 and 28	Proportion of death patients at days 7, 14 and 28
Intensive Care Unit Admission	Days 7, 14 and 28	Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Length of Intensive Care Unit stay	Days 7, 14 and 28	Days of Intensive Care Unit management (days 7, 14 and 28)
Length of hospital stay (days)	Days 7, 14 and 28	Days of Hospitalization (days 7, 14 and 28)
Duration (days) of mechanical ventilation	Days 7, 14 and 28	Days with mechanical ventilation (days 7, 14 and 28)
Clinical status assessed according to the World Health Organization guideline	Days 7, 14 and 28	1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)
Requirement of mechanical ventilation	Days 7, 14 and 28	Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Trial Locations

Locations (1)

Universidad del Rosario; 🇨🇴 Bogota, Cundinamarca, Colombia