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ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
Phase 2 trial testing COVID-19 convalescent plasma in COVID-19 in 71 participants. Terminated before completion.
| Lead sponsor | Corewell Health East |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 16 July 2020 |
| Primary completion | 13 November 2020 |
| Estimated completion | 28 November 2020 |
| Sites | 1 location across United States |
Corewell Health East — full company profile →
18 and older, any sex, with COVID-19 or Severe Acute Respiratory Syndrome (SARS). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Count of group A participants (non-intubated participants requiring \>6 L supplemental oxygen to maintain oxygen saturation \>92% at time of study entry and who are admitted \<14 days) who remain un-intubated
| Group | Value | 95% CI |
|---|---|---|
| Group A | 26 |
Count of group B participants (participants who are intubated at study entry) who die
| Group | Value | 95% CI |
|---|---|---|
| Group B | 17 |
Count of participants who experienced cardio-circulatory arrest
| Group | Value | 95% CI |
|---|---|---|
| Group A | 13 | |
| Group B | 13 |
Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome
| Group | Value | 95% CI |
|---|---|---|
| Group A | 3 | |
| Group B | 0 | |
| Group A | 12 | |
| Group B | 4 | |
| Group A | 0 | |
| Group B | 0 | |
| Group A | 3 | |
| Group B | 1 |
Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 2 | |
| Group B | 7 |
Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of \>25%
| Group | Value | 95% CI |
|---|---|---|
| Group A | 1 | |
| Group B | 1 |
Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
| Group | Value | 95% CI |
|---|---|---|
| Group A | 9 | |
| Group B | 5 |
Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 19 | |
| Group B | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 1 | |
| Group B | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 11 | |
| Group B | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 25 | |
| Group B | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 19 | |
| Group B | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 27 | |
| Group B | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Group A | 37 | |
| Group B | 7 |
Count of participants who received pressor drugs, as ordered by treating physicians
| Group | Value | 95% CI |
|---|---|---|
| Group A | 19 | |
| Group B | 27 |
Length of ICU stay in days, for participants who entered ICU
| Group | Value | 95% CI |
|---|---|---|
| Group A | 17.59 | ± 10.16 |
| Group B | 22.12 | ± 10.37 |
Length of hospital stay in days
| Group | Value | 95% CI |
|---|---|---|
| Group A | 23.63 | ± 9.83 |
| Group B | 26.41 | ± 11.12 |
Number of ventilator-free hospitalized days
| Group | Value | 95% CI |
|---|---|---|
| Group A | 9.13 | ± 12.64 |
| Group B | 14.23 | ± 14.80 |
Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A | Group B |
|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardio-circulatory arrest | Cardiac disorders | — | — |
| Neurological | Nervous system disorders | — | — |
| Bleeding or low hemoglobin | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Reaction | System | Group A | Group B |
|---|---|---|---|
| Low hemaglobin | Blood and lymphatic system disorders | — | — |
| pneumomediastinum | Reproductive system and breast disorders | — | — |
| Bleeding | Blood and lymphatic system disorders | — | — |
| Fever | Infections and infestations | — | — |
| Anterior rectal tear | Skin and subcutaneous tissue disorders | — | — |
| Deep right ear pain | Ear and labyrinth disorders | — | — |
| Minor allergic reaction | Immune system disorders | — | — |
Most-reported serious reactions: Respiratory failure, Cardio-circulatory arrest, Neurological, Bleeding or low hemoglobin, Sepsis.
Data from ClinicalTrials.gov NCT04432272 adverse events section.
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. * Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator * Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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