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

NCT04425837 | Unknown Phase 2

• 1 other identifier: PLASMA COVID-19
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2; Covid-19

Keywords

COVID-19 serotherapy; Mortality; Safety

Outcome Measures

Primary Outcomes (4)

• Mortality

  Death of the patient (yes/no)

  Up to 30 days after the study enrollment

• Adverse events

  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)

  Up to 30 days after the study enrollment

• ICU admission

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

  Up to 30 days after the study enrollment

• Mechanical ventilation

  Mechanical ventilation requirement (yes/no)

  Up to 30 days after the study enrollment

Secondary Outcomes (12)

• ICU length

  Up to 30 days after the study enrollment

• Reduction of D Dimer

  Assessment at day 30 after study enrollment

• LDH reduction

  Assessment at day 30 after study enrollment

• Reduction of Troponin level

  Assessment at day 30 after study enrollment

• Decrease in ferritin level

  Assessment at day 30 after study enrollment

Study Arms (2)

Standard care alone

ACTIVE COMPARATOR

Other: Standard care

SARS-CoV-2 convalescent plasma treatment plus standard care

EXPERIMENTAL

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

Interventions

SARS-CoV-2 convalescent plasma treatment 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

SARS-CoV-2 convalescent plasma treatment plus standard care

Standard care OTHER

Standard care according to guidelines and national regulations

SARS-CoV-2 convalescent plasma treatment plus standard care; Standard care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Fundación Santa Fe de Bogotá

Bogotá, Cundinamarca, 110111, Colombia

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Guillermo E Quintero, Hematologist

CONTACT

5716030303; quiquequintero@yahoo.com.mx

José A De la Hoz, Epidemiologist

CONTACT

5716030303; jose.delahoz@fsfb.org.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CO (1)