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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421404
• Other study ID #: 20-30794
• Status: Completed
• Phase: Phase 2
• Start date: June 9, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Enrollment:

1. Patients =18 years of age

2. Hospitalized with COVID-19

3. Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness

4. Pulmonary infiltrates on chest imaging

5. Oxygenation of <95% on room air

6. Laboratory confirmed COVID-19

Exclusion Criteria

1. Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure

2. Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing

3. Currently experiencing severe hypoxemic failure, as defined in study endpoints

4. Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months

5. 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

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2

Intervention

Biological:
• COVID-19 Convalescent Plasma (CCP)
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California
United States	UCSF Medical Center at Mount Zion	San Francisco	California
United States	University of California, San Francisco Medical Center (Parnassus Campus)	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Priscilla Hsue, MD	Blood Systems Research Institute, San Francisco General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Ventilation or Death Endpoint	Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.	Day 14
Secondary	Mechanical Ventilation or Death Endpoint	Progression to mechanical ventilation or death within the first 28 days of enrollment.	Day 28
Secondary	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	Day 29