COVID-19
Conditions
Keywords
Anti-SARS-CoV-2 plasma
Brief summary
The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).
Detailed description
This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients. After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.
Interventions
DRUGanti-SARS-CoV-2 plasma
Administration of anti-SARS-CoV-2 convalescent plasma
OTHERPlacebo
Administration of placebo (albumin 5%)
Sponsors
Kashif Khan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age * Hospitalized with COVID-19-related acute respiratory symptoms * Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 (Hospitalized, no oxygen therapy) or 4 (Hospitalized, on oxygen by mask or nasal prongs) * Laboratory-confirmed COVID-19 * First signs of infection occurring no more than 14 days prior to enrollment
Exclusion criteria
* Receipt of pooled immunoglobulin in the past 30 days * Contraindication to transfusion or history of prior reactions to transfusion blood products * Admission to intensive care unit at any point during hospital course prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression measured by WHO scale | Day 0 through Day 28 (or hospital discharge) | Disease progression from the state at randomization (with a 3 or 4 on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is 6 or greater on the WHO scale) during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of maximum WHO score per group | Day 0 through Day 28 (or hospital discharge) | Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group |
| Comparison of decrease of median and maximum WHO score per group | Day 0 through Day 28 (or hospital discharge) | Comparison of the median and maximum daily WHO scores during the study period per group |
| Comparison of time to clinical improvement per group | Day 0 through Day 28 (or hospital discharge) | Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale 2 first reached for at least 1 day) |
| Comparison of time to reach score of 6 or greater on the WHO scale | Day 0 through Day 28 (or hospital discharge) | Evaluate the time to reach score of at least 6 within 28 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of hospital length of stay per group | Day 0 through Day 28 (or hospital discharge) | Evaluate number of days hospitalized |
| Comparison of ICU length of stay per group | Day 0 through Day 28 (or hospital discharge) | Evaluate number of hours in the ICU |
Outcome results
None listed