Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

NCT04554992 | Completed Phase 1 FDA Drug

• 1 other identifier: 00025121
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of serious adverse events related to the treatment intervention.

  Total number of grade 3 and above throughout study period

  up to 60 days post-transfusion

• Mortality at Day 28 post-hospital admission.

  All cause mortality at day 28

  up to 28 days post-transfusion

Secondary Outcomes (4)

• Length of hospital stay

  up to 60 days post-transfusion

• Length of supplemental oxygen requirement.

  up to 60 days post-transfusion

• Length of mechanical ventilation requirement.

  up to 60 days post-transfusion

• Length of ICU stay

  up to 60 days post-transfusion

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed.

Biological: COVID 19 Convalescent Plasma

Interventions

COVID 19 Convalescent Plasma BIOLOGICAL

COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection

Treatment

Eligibility Criteria

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

You may qualify if:

• Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)

You may not qualify if:

• History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\].
• Has underlying uncompensated and untreatable end stage disease.
• Fluid overload or other condition that would contraindicate administration of plasma

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hopsital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

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

Study Officials

• Eric Salazar, MD, PhD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pathologist

Model Details: Given that this is a pilot study to evaluate the safety of treatment with convalescent COVID-19 plasma versus standard care in subjects with severe and/or critical COVID-19 between the cases and historical controls without predetermined data, a convenient sample size of 700 patients (350 per group) has been proposed.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 18, 2020
• Study Start: March 20, 2020
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: April 29, 2026

Record last verified: 2020-10

Locations

US (1)