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

NCT04421404 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-30794
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19; Sars-CoV2

Keywords

COVID-19; Sars-CoV2; Convalescent plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mechanical Ventilation or Death Endpoint

  Day 28

• 8-Point Ordinal Scale Endpoint

  Day 29

Study Arms (2)

COVID-19 Convalescent Plasma

EXPERIMENTAL

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.

Biological: COVID-19 Convalescent Plasma (CCP)

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

COVID-19 Convalescent Plasma (CCP) BIOLOGICAL

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.

COVID-19 Convalescent Plasma

Placebo BIOLOGICAL

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Priscilla Hsue, MD: lead
• Vitalant Research Institute: collaborator
• San Francisco General Hospital: collaborator

Study Sites (3)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

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

San Francisco, California, 94143, 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

Limitations and Caveats

This study was limited by the small sample of hospitalized, hypoxic patients, limiting the generalizability of the results. Most participants were beyond 72 hours of symptom onset, the period when studies suggest CCP is most likely to be beneficial.

Results Point of Contact

• Title: Dr. Annie Luetkemeyer
• Organization: UCSF

annie.luetkemeyer@ucsf.edu

415-476-4082

Study Officials

• Priscilla Hsue, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Annie Leutkemeyer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: June 9, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 7, 2022
• Results First Posted: August 25, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)