The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of
anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of
progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).
Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml
divided into two doses intravenously. Outcomes will be measured as follows:
* Group of patients with critical illness:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
Secondary outcomes:
- Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
- Group of patients at high risk of progression:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
- Admission to ICU in 30 days
- Mechanical ventilation requirement
Secondary outcomes:
- Hospital/Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
Biological: SARS-CoV-2 convalescent plasma treatment
Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration
Other: Standard care
Standard care according to guidelines and national regulations
Inclusion Criteria:
All patients
- Patients diagnosed with COVID-19 infection by RT-PCR technique
- Patients ≥ 18 years of age
- Patients in standard care according to the national guide
- Onset of symptoms ≤ 14 days
- Signature of informed consent report
Patients at high risk of progression, defined by all of the following:
- Score greater than 9 on the CALL scale
- Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
- X-ray or CT compatible with pneumonia
- Hospitalized patients
Critically ill patients, defined by any of the following:
- Mechanical ventilation requeriment
- Patients in Intensive Care Unit or Intermediate Care Unit
- Ventilatory failure, septic shock, dysfunction or multi-organ failure
Exclusion Criteria:
- Negative RT-PCR result from secretion 48 hours prior to study recruitment
- History of allergic reaction to blood or plasma in patients with a known history of
IgA deficiency
- Patients participating in other clinical trial
- History of allergy to blood products
- History of confirmed infection and that required antibiotic or antifungal treatment 30
days prior to recruitment
- Pregnant women
Fundación Santa Fe de Bogotá
Bogotá, Cundinamarca, Colombia
Investigator: José De la Hoz, Epidemiologist
Contact: 5716030303
jose.delahoz@fsfb.org.co
Guillermo E Quintero, Hematologist
5716030303 - 1221
quiquequintero@yahoo.com.mx
José A De la Hoz, Epidemiologist
5716030303 - 1127
jose.delahoz@fsfb.org.co