CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- NYU Langone Health
- Enrollment
- 941
- Locations
- 8
- Primary Endpoint
- Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days
Time Frame: 14 days post-randomization
Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation \& Mechanical ventilation; pO2/FIO2 \>/= 150 or SpO2/FIO2 \>/=200 8 Mechanical ventilation pO2/FIO2 \< 150 (SpO2/FIO2 \<200) or vasopressors 9 Mechanical ventilation pO2/FIO2 \< 150 and vasopressors, dialysis or ECMO Death 10 Dead
Secondary Outcomes
- Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days(28 days post-randomization)