Convalescent Plasma for the Treatment of Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Convalescent Plasma for the Treatment of Patients With COVID-19

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04372368
• Other study ID #: 20-0990
• Status: No longer available

Study information

• Verified date: August 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

This expanded access program will provide access to COVID-19 convalescent plasma 150 or more individuals with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations at participating hospitals in Colorado.COVID-19 convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19.

Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.

Description:

COVID-19 convalescent plasma will be obtained from FDA registered blood banks and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemptio n-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

The primary objective of this expanded access program is to provide COVID-19 convalescent plasma to patients with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations.

The secondary objective will be the evaluation of safety, as assessed by incidents of adverse events judged by the treating physician to be potentially related to the administration of COVID-19 convalescent plasma.

Exploratory objectives will include assessments for antibody responses for patients that receive convalescent plasma. An exploratory analysis may be conducted correlating the level of neutralizing antibody titers with clinical outcomes observed. Due to the need to monitoring COVID19 antibody responses following infusion, blood testing at day 1 post-treatment and at discharge will be obtained as part of enrollment.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Laboratory confirmed diagnosis of infection with SARS-CoV-2

• Age at least 18 years

• Laboratory confirmed diagnosis of infection with SARS-CoV-2

• Admitted to participating facility for the treatment of COVID-19 complications

• Moderate-to-Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

• Informed consent provided by the patient or healthcare proxy

• Moderate COVID-19 is defined by one or more of the following:

• Hospitalized with COVID-19

• Respiratory rate >25/min

• Oxygen saturation <96%

• With or without radiographic evidence of pulmonary involvement

• Severe COVID-19 is defined by one or more of the following:

• dyspnea

• respiratory frequency = 30/min

• blood oxygen saturation = 93%

• Radiographic evidence of pulmonary disease

• Life-threatening COVID-19 is defined as one or more of the following:

• respiratory failure requiring mechanical ventilation or non-rebreather oxygenation in the Intensive Care Unit.

• Prone oxygenation.

• multiple organ dysfunction or failure

Exclusion Criteria:

• Does not meet inclusion criteria

• History of transfusion reactions or contraindication to receiving convalescent plasma

• Risk of transfusion exceeds potential benefit based on clinician or blood bank determination.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Biological:
• COVID-19 Convalescent Plasma
1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr)

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	UCHealth Memorial Hospital North	Colorado Springs	Colorado
United States	Denver Health Medical Center	Denver	Colorado
United States	UCHealth Poudre Valley Hospital	Fort Collins	Colorado
United States	UCHealth Highlands Ranch Hospital	Highlands Ranch	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States,