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

Primary Purpose

Sars-CoV2, Covid-19

Status

Unknown status

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

SARS-CoV-2 convalescent plasma treatment

Standard care

About this trial

This is an interventional treatment trial for Sars-CoV2 focused on measuring COVID-19 serotherapy, Mortality, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fundación Santa Fe de Bogotá

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care alone

SARS-CoV-2 convalescent plasma treatment plus standard care

Arm Description

Outcomes

Primary Outcome Measures

Mortality

Death of the patient (yes/no)

Adverse events

Presence of any of the following adverse events (yes/no): Nonhemolytic febrile reactions Allergic reactions Acute hemolytic reactions Non-immune hemolysis Acute transfusion-related lung damage Transfusion-related circulatory overload Metabolic reactions Hypotensive reactions Delayed hemolytic reactions Post transfusion purple Graft versus host disease Bacterial contamination of blood components Viral infections Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)

ICU admission

Admitted to intensive care units (ICUs) (yes/no)

Mechanical ventilation

Mechanical ventilation requirement (yes/no)

Secondary Outcome Measures

ICU length

Intensive care unit length of stay

Reduction of D Dimer

D dimer reduction below 1mcg / ml

LDH reduction

Reduction of LDH below 350 IU / L

Reduction of Troponin level

Reduction of troponin level to than 8 pg / mL

Decrease in ferritin level

Decrease in ferritin level below 1025 mcg / L

Decrease in procalcitonin level

Decrease in procalcitonin level below 0.1ng / ml

Decrease in CRP

Decrease in CRP level bellow <8 mg / L

Increase in lymphocyte count

Increase in lymphocyte count greater than 0.6 x 10-9 / L

Increase in PaO2 / Fio2

Increase in PaO2 / Fio2 greater than 200

Decrease in Sequential Organ failure assessment (SOFA ) score

Scale of 24 points, greater number indicates worst outcome

Extracorporeal membrane oxygenation (ECMO)

Extracorporeal membrane oxygenation requirement (ECMO)

Lung infiltration

Decrease in the percentage of lung infiltration

Full Information

NCT ID

NCT04425837

First Posted

May 29, 2020

Last Updated

June 8, 2020

Sponsor

Fundación Santa Fe de Bogota

1. Study Identification

Unique Protocol Identification Number

NCT04425837

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 2020 (Anticipated)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundación Santa Fe de Bogota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sars-CoV2, Covid-19

Keywords

COVID-19 serotherapy, Mortality, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care alone

Arm Type

Active Comparator

Arm Title

SARS-CoV-2 convalescent plasma treatment plus standard care

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 convalescent plasma treatment

Intervention Description

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

Other

Intervention Name(s)

Standard care

Intervention Description

Standard care according to guidelines and national regulations

Primary Outcome Measure Information:

Title

Mortality

Description

Death of the patient (yes/no)

Time Frame

Up to 30 days after the study enrollment

Title

Adverse events

Description

Time Frame

Up to 30 days after the study enrollment

Title

ICU admission

Description

Admitted to intensive care units (ICUs) (yes/no)

Time Frame

Up to 30 days after the study enrollment

Title

Mechanical ventilation

Description

Mechanical ventilation requirement (yes/no)

Time Frame

Up to 30 days after the study enrollment

Secondary Outcome Measure Information:

Title

ICU length

Description

Intensive care unit length of stay

Time Frame

Up to 30 days after the study enrollment

Title

Reduction of D Dimer

Description

D dimer reduction below 1mcg / ml

Time Frame