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

NCT ID: NCT04425837

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-02-28

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.

Conditions

Sars-CoV2; Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care alone

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Standard care according to guidelines and national regulations

SARS-CoV-2 convalescent plasma treatment plus standard care

Group Type: EXPERIMENTAL

SARS-CoV-2 convalescent plasma treatment

Intervention Type: BIOLOGICAL

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

Standard care

Intervention Type: OTHER

Standard care according to guidelines and national regulations

Interventions

SARS-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

Intervention Type: BIOLOGICAL

Standard care

Standard care according to guidelines and national regulations

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Enrique Quintero-Vega

Hematologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundación Santa Fe de Bogotá

Bogotá, Cundinamarca, Colombia

Countries

Colombia

Central Contacts

Guillermo E Quintero, Hematologist

Role: CONTACT

quiquequintero@yahoo.com.mx

5716030303 ext. 1221

José A De la Hoz, Epidemiologist

Role: CONTACT

jose.delahoz@fsfb.org.co

5716030303 ext. 1127

Facility Contacts

José De la Hoz, Epidemiologist

Role: primary

jose.delahoz@fsfb.org.co

5716030303 ext. 1127

Other Identifiers

PLASMA COVID-19

Identifier Type: -

Identifier Source: org_study_id