Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
- Conditions
- Sars-CoV2Covid-19
- Interventions
- Biological: SARS-CoV-2 convalescent plasma treatmentOther: Standard care
- Registration Number
- NCT04425837
- Lead Sponsor
- Fundación Santa Fe de Bogota
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 236
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SARS-CoV-2 convalescent plasma treatment plus standard care Standard care - SARS-CoV-2 convalescent plasma treatment plus standard care SARS-CoV-2 convalescent plasma treatment - Standard care alone Standard care -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method LDH reduction Assessment at day 30 after study enrollment Reduction of LDH below 350 IU / L
Increase in lymphocyte count Assessment at day 30 after study enrollment Increase in lymphocyte count greater than 0.6 x 10-9 / L
Decrease in Sequential Organ failure assessment (SOFA ) score Assessment at day 30 after study enrollment Scale of 24 points, greater number indicates worst outcome
ICU length Up to 30 days after the study enrollment Intensive care unit length of stay
Reduction of Troponin level Assessment at day 30 after study enrollment Reduction of troponin level to than 8 pg / mL
Decrease in CRP Assessment at day 30 after study enrollment Decrease in CRP level bellow \<8 mg / L
Reduction of D Dimer Assessment at day 30 after study enrollment D dimer reduction below 1mcg / ml
Decrease in procalcitonin level Assessment at day 30 after study enrollment Decrease in procalcitonin level below 0.1ng / ml
Decrease in ferritin level Assessment at day 30 after study enrollment Decrease in ferritin level below 1025 mcg / L
Increase in PaO2 / Fio2 Assessment at day 30 after study enrollment Increase in PaO2 / Fio2 greater than 200
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
Trial Locations
- Locations (1)
Fundación Santa Fe de Bogotá
🇨🇴Bogotá, Cundinamarca, Colombia