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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
