Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19

NCT04388410 | Unknown Phase 2 DMC

• 1 other identifier: 3380
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.

Conditions

COVID-19

Keywords

SARS-CoV-2; convalescent plasma; randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Severity and death

  Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.

  28 days

• Adverse events that require study treatment interruption

  Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events

  During the 28 day of follow up

Secondary Outcomes (8)

• Time to clinical improvement

  28 days

• Severity and death

  Days 1, 3, 5, 7, 12, 14, and 21.

• Antibodies against SARS-CoV-2

  Days 0, 3, 7, 14, 21, 28

• Disease progression 1

  28 days

• Disease progression 2

  Days 7,14, 21, 28

Study Arms (2)

convalescent plasma

EXPERIMENTAL

Convalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control

Biological: convalescent plasma

Normal saline

PLACEBO COMPARATOR

Normal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma

Biological: convalescent plasma

Interventions

convalescent plasma BIOLOGICAL

Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.

Normal saline; convalescent plasma

Eligibility Criteria

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

You may qualify if:

• Adults 18 years of age and older.
• Confirmed SARS-CoV2 infection
• Hospitalized for COVID 19
• Severe disease or risk for severe disease
• Informed consent from patient or responsible person.

You may not qualify if:

• History of allergic reactions to blood products
• SOFA scale \>12 points
• Absolute contraindication for administration of plasma
• Participation in other blinded clinical trial
• Projected life expectancy less than 3 months
• Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• TecSalud Investigación Clínica: collaborator
• Instituto Nacional de Enfermedades Respiratorias: collaborator
• Instituto Nacional de Cardiologia Ignacio Chavez: collaborator
• Hospital General Dr. Manuel Gea González: collaborator
• Hospital Regional de Alta Especialidad del Bajio: collaborator
• Instituto Nacional de Cancerologia de Mexico: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Tlalpan, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Juan G Sierra-Madero, MD

  Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan G Sierra-Madero, MD

CONTACT

+52556559675; jsmadero@yahoo.com

Alvaro Lopez-Iñiguez, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Encasement of plasma and saline bags with an identical material will be done in Blood bank
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Randomized, double-blinded, multicenter, placebo-controlled study

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: August 25, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)