Phase 2
N=941
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
COVID-19 · Coronavirus · Coronavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04364737 ↗Enrolled (actual)
941
Serious AEs
23.4%
Results posted
Apr 2022
Primary outcome: Primary: Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days — 2; 2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Convalescent Plasma (Biological); Saline solution (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days |
2; 2 | — |
| SECONDARY Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days |
2; 2 | — |
Summary
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.
Eligibility Criteria
Inclusion Criteria
- Patients ≥18 years of age
- Hospitalized with laboratory confirmed COVID-19
- One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
- Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
- On supplemental oxygen, non-invasive ventilation or high-flow oxygen
- Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
Exclusion Criteria
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
- Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Volume overload secondary to congestive heart failure or renal failure
- Unlikely to survive past 72 hours from screening based on the assessment of the investigator
- Unlikely to be able to assess and follow outcome due to poor functional status
Data sourced from ClinicalTrials.gov (NCT04364737). 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.