ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)

NCT04432272 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2020-198
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Severe Acute Respiratory Syndrome (SARS); Coronavirus Infections

Keywords

therapeutic treatment; COVID-19 convalescent plasma; anti-SARS-CoV-2 antibody; IgA; IgG; COVID-19 pandemic

Outcome Measures

Primary Outcomes (2)

• Avoidance of Intubation at 28 Days (Group A)

  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

  28 days

• Mortality (Group B)

  Count of group B participants (participants who are intubated at study entry) who die

  28 days

Secondary Outcomes (17)

• Cardio-circulatory Arrest

  28 days

• Patient Outcome at 28 Days

  28 days

• Renal Failure

  28 days

• Liver Failure

  28 days

• Cytokine Storm

  28 days

Study Arms (2)

Group A

EXPERIMENTAL

Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring \>6 L of oxygen to maintain oxygen saturation \>92%. Patient may not require intubation, and may be admitted for no longer than 14 days.

Biological: COVID-19 convalescent plasma

Group B

EXPERIMENTAL

Hospitalized COVID-19 patients ages ≥18 years requiring intubation.

Biological: COVID-19 convalescent plasma

Interventions

COVID-19 convalescent plasma BIOLOGICAL

Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older.
• Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2 Reverse-transcription polymerase chain reaction (RT-PCR) testing.
• Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of breath) at time of screening.
• Patient requires \>6 L nasal cannula oxygen (Group A) or intubated (Group B).
• Patient (or their legal authorized representative) is willing and able to provide written informed consent and comply with all protocol requirements.

You may not qualify if:

• For patients in Group A admitted for \>14 days
• Female subjects with positive pregnancy test, breastfeeding, or planning to become --pregnant or breastfeed during the study period.
• Receipt of pooled immunoglobulin in past 30 days.
• Contraindication to transfusion or history of prior reactions to transfusion blood products.
• Patients currently undergoing cancer treatment or those who are presently immunocompromised.
• Patient who in the opinion of the investigator will not be a good study candidate.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Limitations and Caveats

Early termination due to changes in the Emergency Use Authorization for plasma during COVID-19. All plasma was labeled either low titer or high titer. The protocol required untitered plasma be used, which resulted in inability to complete the study and early termination.

Results Point of Contact

• Title: Matthew Sims, MD
• Organization: Beaumont Hospitals

matthew.sims@beaumont.org

248-551-0027

Study Officials

• Matthew Sims, MD PhD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No parties blinded as to receipt of study article. Participant, care provider and investigator blinded to actual antibody concentration in unit of plasma provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine

Model Details: Prospective, single health system, non-randomized, open-label study.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: July 16, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 28, 2020
• Last Updated: March 9, 2022
• Results First Posted: November 22, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)