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Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients (CAPRI)

Primary Purpose

COVID-19, Sars-CoV2

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

COVID-19 Convalescent Plasma (CCP)

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Sars-CoV2, Convalescent plasma

Eligibility Criteria

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

Inclusion Criteria for Enrollment:

Patients ≥18 years of age
Hospitalized with COVID-19
Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
Pulmonary infiltrates on chest imaging
Oxygenation of <95% on room air
Laboratory confirmed COVID-19

Exclusion Criteria

Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
Currently experiencing severe hypoxemic failure, as defined in study endpoints
Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
Not currently enrolled another interventional clinical trial of COVID-19 treatment.

Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication.

Note: Pregnancy is not exclusionary but will merit additional discussion of risks & benefits in the context of ongoing pregnancy

Sites / Locations

San Francisco General Hospital
UCSF Medical Center at Mount Zion
University of California, San Francisco Medical Center (Parnassus Campus)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVID-19 Convalescent Plasma

Placebo

Arm Description

Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.

Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.

Outcomes

Primary Outcome Measures

Mechanical Ventilation or Death Endpoint

Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.

Secondary Outcome Measures

Mechanical Ventilation or Death Endpoint

Progression to mechanical ventilation or death within the first 28 days of enrollment.

8-Point Ordinal Scale Endpoint

Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale. 8 Point WHO Ordinal Scale of Clinical Status: Uninfected (No clinical or virological evidence of infection) - 0 Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2 Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4 Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intubation and mechanical ventilation) - 6 Hospitalized Severe Disease (Ventilation + Additional organ support (pressors, RRT, ECMO)) - 7 Dead (Death) - 8

Full Information

NCT ID

NCT04421404

First Posted

June 3, 2020

Last Updated

October 5, 2022

Sponsor

Priscilla Hsue, MD

Collaborators

Vitalant Research Institute, San Francisco General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04421404

Brief Title

Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

Acronym

CAPRI

Official Title

A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 9, 2020 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Priscilla Hsue, MD

Collaborators

Vitalant Research Institute, San Francisco General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

Detailed Description

A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

6. Conditions and Keywords

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

COVID-19, Sars-CoV2

Keywords

COVID-19, Sars-CoV2, Convalescent plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Subjects enrolled in the study will be randomized using a web based randomization procedure to receive convalescent plasma versus non-immune plasma at a 1:1 ratio.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Study investigators analyzing the data and participants will be blinded to the randomization. It may not be feasible to blind nursing staff to the treatment assignment to ensure proper ABO checking of the plasma unit at bedside per standard transfusion procedures, but every effort will be made to preserve blinding of the investigators, participant, and primary team providing care. An unblinded research assistant who is not involved in other aspects of the study will randomize the participant once enrolled. Randomization will be provided to an unblinded provider who is not part of the care team who will place the order for the plasma (CCP vs. control plasma) using a paper order that will not be part of the electronic medical record. The safety monitoring committee (SMC) will review study data, including unblinded data, to evaluate the safety, efficacy, study progress, and conduct of the study.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 Convalescent Plasma

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.

Intervention Type

Biological

Intervention Name(s)

COVID-19 Convalescent Plasma (CCP)

Intervention Description

COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.

Primary Outcome Measure Information:

Title

Mechanical Ventilation or Death Endpoint

Description

Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

Mechanical Ventilation or Death Endpoint

Description

Progression to mechanical ventilation or death within the first 28 days of enrollment.

Time Frame

Day 28

Title

8-Point Ordinal Scale Endpoint

Description

Time Frame

Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Enrollment: Patients ≥18 years of age Hospitalized with COVID-19 Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness Pulmonary infiltrates on chest imaging Oxygenation of <95% on room air Laboratory confirmed COVID-19 Exclusion Criteria Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing Currently experiencing severe hypoxemic failure, as defined in study endpoints Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months Not currently enrolled another interventional clinical trial of COVID-19 treatment. Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication. Note: Pregnancy is not exclusionary but will merit additional discussion of risks & benefits in the context of ongoing pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Priscilla Hsue, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Annie Leutkemeyer, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Facility Name

UCSF Medical Center at Mount Zion

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

University of California, San Francisco Medical Center (Parnassus Campus)

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

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