Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Plasma
- Conditions
- Coronavirus
- Sponsor
- Universidad del Rosario
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Change in Viral Load
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
Juan Manuel Anaya Cabrera
MD, PhD, Principal Investigator
Universidad del Rosario
Eligibility Criteria
Inclusion Criteria
- •Fulfilling all the following criteria
- •Olerder than
- •Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
- •Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
- •Sequential Organ Failure Assessment score (SOFA) \<
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Female subjects who are pregnant or breastfeeding.
- •Patients with prior allergic reactions to transfusions.
- •Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
- •Patients with surgical procedures in the last 30 days.
- •Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
- •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).
- •Demonstrated coinfection that explains the patient's symptoms
- •End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
- •Child Pugh C stage liver cirrhosis.
- •High cardiac output diseases.
Arms & Interventions
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. Simultaneously, they will receive the standard therapy defined by institutional protocol.
Intervention: Plasma
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. Simultaneously, they will receive the standard therapy defined by institutional protocol.
Intervention: Standard Therapy
Control Group
Participants included in the control group will receive standard therapy defined by institutional protocol.
Intervention: Standard Therapy
Outcomes
Primary Outcomes
Change in Viral Load
Time Frame: Days 0, 4, 7, 14 and 28
Copies of COVID-19 per ml
Change in Immunoglobulin G COVID-19 Titers
Time Frame: Days 0, 4, 7, 14 and 28
Immunoglobulin G COVID-19 antibodies
Secondary Outcomes
- Mortality(Days 7, 14 and 28)
- Length of hospital stay (days)(Days 7, 14 and 28)
- Duration (days) of mechanical ventilation(Days 7, 14 and 28)
- Length of Intensive Care Unit stay(Days 7, 14 and 28)
- Intensive Care Unit Admission(Days 7, 14 and 28)
- Clinical status assessed according to the World Health Organization guideline(Days 7, 14 and 28)
- Requirement of mechanical ventilation(Days 7, 14 and 28)