Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19

Fundación Santa Fe de Bogota236 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

236

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Death of the patient (yes/no)

Time frame: Up to 30 days after the study enrollment

Adverse events

Presence of any of the following adverse events (yes/no): 1. Nonhemolytic febrile reactions 2. Allergic reactions 3. Acute hemolytic reactions 4. Non-immune hemolysis 5. Acute transfusion-related lung damage 6. Transfusion-related circulatory overload 7. Metabolic reactions 8. Hypotensive reactions 9. Delayed hemolytic reactions 10. Post transfusion purple 11. Graft versus host disease 12. Bacterial contamination of blood components 13. Viral infections 14. Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)

Time frame: Up to 30 days after the study enrollment

ICU admission

Admitted to intensive care units (ICUs) (yes/no)

Time frame: Up to 30 days after the study enrollment

Mechanical ventilation

Mechanical ventilation requirement (yes/no)

Time frame: Up to 30 days after the study enrollment

Secondary Outcomes

ICU length

Intensive care unit length of stay

Time frame: Up to 30 days after the study enrollment

Reduction of D Dimer

D dimer reduction below 1mcg / ml