Clinical trial NCT04421404: Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Sars-CoV2
Keywords: COVID-19
Sars-CoV2
Convalescent plasma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Vitalant Research Institute
name: San Francisco General Hospital
First posted: 2020-06-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical Ventilation or Death Endpoint
timeFrame: Day 14
Secondary outcomes:
measure: Mechanical Ventilation or Death Endpoint
timeFrame: Day 28
measure: 8-Point Ordinal Scale Endpoint
timeFrame: Day 29
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mount Zion
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center (Parnassus Campus)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Priscilla Hsue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Annie Leutkemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: