Phase 2 N=34 Randomized Triple-blind Treatment

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

COVID-19 · Sars-CoV2

Bottom Line

View on ClinicalTrials.gov: NCT04421404 ↗

Enrolled (actual)

Serious AEs

8.8%

Results posted

Aug 2021

Primary outcome: Primary: Mechanical Ventilation or Death Endpoint — 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: COVID-19 Convalescent Plasma (CCP) (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Priscilla Hsue, MD
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Mechanical Ventilation or Death Endpoint	2; 0	—
SECONDARY Mechanical Ventilation or Death Endpoint	2; 0	—
SECONDARY 8-Point Ordinal Scale Endpoint	2.43; 1.93; 2.15; 2.14; 3.92; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04421404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.