Clinical trial NCT04425837: Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
Official title: Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sars-CoV2
Covid-19
Keywords: COVID-19 serotherapy
Mortality
Safety
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Up to 30 days after the study enrollment
measure: Adverse events
timeFrame: Up to 30 days after the study enrollment
measure: ICU admission
timeFrame: Up to 30 days after the study enrollment
measure: Mechanical ventilation
timeFrame: Up to 30 days after the study enrollment
Secondary outcomes:
measure: ICU length
timeFrame: Up to 30 days after the study enrollment
measure: Reduction of D Dimer
timeFrame: Assessment at day 30 after study enrollment
measure: LDH reduction
timeFrame: Assessment at day 30 after study enrollment
measure: Reduction of Troponin level
timeFrame: Assessment at day 30 after study enrollment
measure: Decrease in ferritin level
timeFrame: Assessment at day 30 after study enrollment
measure: Decrease in procalcitonin level
timeFrame: Assessment at day 30 after study enrollment
measure: Decrease in CRP
timeFrame: Assessment at day 30 after study enrollment
measure: Increase in lymphocyte count
timeFrame: Assessment at day 30 after study enrollment
measure: Increase in PaO2 / Fio2
timeFrame: Assessment at day 30 after study enrollment
measure: Decrease in Sequential Organ failure assessment (SOFA ) score
timeFrame: Assessment at day 30 after study enrollment
measure: Extracorporeal membrane oxygenation (ECMO)
timeFrame: Assessment at day 30 after study enrollment
measure: Lung infiltration
timeFrame: Assessment at day 30 after study enrollment
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
state: Cundinamarca
Study officials:
References: