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

Fundación Santa Fe de Bogota

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Sars-CoV2; Covid-19

Treatments: Biological: SARS-CoV-2 convalescent plasma treatment; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04425837

PLASMA COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Standard care alone

Active Comparator group

Treatment:

Other: Standard care

SARS-CoV-2 convalescent plasma treatment plus standard care

Experimental group

Treatment:

Biological: SARS-CoV-2 convalescent plasma treatment

Other: Standard care