Covid-19, Sars-CoV2
Conditions
Keywords
COVID-19 serotherapy, Mortality, Safety
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSARS-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
OTHERStandard care
Standard care according to guidelines and national regulations
Sponsors
Fundación Santa Fe de Bogota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 30 days after the study enrollment | Death of the patient (yes/no) |
| Adverse events | Up to 30 days after the study enrollment | 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) |
| ICU admission | Up to 30 days after the study enrollment | Admitted to intensive care units (ICUs) (yes/no) |
| Mechanical ventilation | Up to 30 days after the study enrollment | Mechanical ventilation requirement (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in ferritin level | Assessment at day 30 after study enrollment | Decrease in ferritin level below 1025 mcg / L |
| Decrease in procalcitonin level | Assessment at day 30 after study enrollment | Decrease in procalcitonin level below 0.1ng / ml |
| Decrease in CRP | Assessment at day 30 after study enrollment | Decrease in CRP level bellow \<8 mg / L |
| Increase in lymphocyte count | Assessment at day 30 after study enrollment | Increase in lymphocyte count greater than 0.6 x 10-9 / L |
| ICU length | Up to 30 days after the study enrollment | Intensive care unit length of stay |
| Decrease in Sequential Organ failure assessment (SOFA ) score | Assessment at day 30 after study enrollment | Scale of 24 points, greater number indicates worst outcome |
| Extracorporeal membrane oxygenation (ECMO) | Assessment at day 30 after study enrollment | Extracorporeal membrane oxygenation requirement (ECMO) |
| Lung infiltration | Assessment at day 30 after study enrollment | Decrease in the percentage of lung infiltration |
| Increase in PaO2 / Fio2 | Assessment at day 30 after study enrollment | Increase in PaO2 / Fio2 greater than 200 |
| Reduction of D Dimer | Assessment at day 30 after study enrollment | D dimer reduction below 1mcg / ml |
| LDH reduction | Assessment at day 30 after study enrollment | Reduction of LDH below 350 IU / L |
| Reduction of Troponin level | Assessment at day 30 after study enrollment | Reduction of troponin level to than 8 pg / mL |
Countries
Colombia
Contacts
Primary ContactGuillermo E Quintero, Hematologist
Backup ContactJosé A De la Hoz, Epidemiologist
Outcome results
None listed