TABLE 2.
Summary of clinical trials in North America (excludes trials that only study donation)
Sponsor | Control | Participants | Population |
---|---|---|---|
Hackensack Meridian Health | None (single arm) | 55 |
Two tracks: ‐Hospitalized, without mechanical ventilation ‐Hospitalized, with mechanical ventilation |
Primary outcomes: ‐First track: mechanical ventilation rate at 7 days from starting treatment ‐Second track: mortality at 30 days | |||
Hamilton Health Sciences Corporation | Standard of care | 1200 | Hospitalized, nonintubated patients |
Primary outcomes: Intubation or death in the hospital at 30 days | |||
Stony Brook University | Standard plasma | 500 |
Hospitalized patients (intubation status unspecified) |
Primary outcomes: Ventilator‐free days through Day 28 postrandomization (patients who die in this period are assigned 0 days) | |||
University of Chicago | None (single arm) | 10 | Severe or immediately life‐threatening disease |
Primary outcomes: ‐Number of consented donors, amount of plasma successfully harvested ‐Number of patients transfused ‐Level of respiratory support (e.g., room air, high flow oxygen, intubation) at 28 days after plasma administration | |||
Johns Hopkins University | Standard plasma | 150 |
Asymptomatic, with negative PCR test and high risk exposure and higher risk for severe illness |
Primary outcomes: ‐Death ‐Requiring mechanical ventilation and/or in ICU ‐Non‐ICU hospitalization, requiring supplemental oxygen ‐Non‐ICU hospitalization, not requiring supplemental oxygen ‐Not hospitalized, but with clinical and laboratory evidence of COVID‐19 infection ‐Not hospitalized, no clinical evidence of COVID‐19 infection, but positive PCR for SARS‐CoV‐2 | |||
Baylor Research Institute | Standard of care | 115 |
Hospitalized patients (intubation status unspecified) |
Primary outcome: Reduction in ventilation and oxygen support |