Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection

NCT06084351 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: LCH- 1Apr2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource \[2\]. Currently, the FDA suggested guidelines for use include "severe", "critical" or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness \[1\], before multiorgan failure or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus standard of care vs. standard of care. The primary clinical endpoint will be time to clinical improvement within 28 days after randomization (based on the ordinal scale as specified below). The purpose of this trial will be to obtain data which can be further utilized in future clinical trials and help clinicians understand the effectiveness of CP.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement within 28 days of randomization

  Clinical improvement will be defined as a two-point reduction in patients' admission status on a 6-point ordinal scale, or discharge from the hospital, whichever comes first. The 6-point scale is as follows: Discharged = 0 Not requiring supplemental oxygen =1 Requiring supplemental oxygen =2 Requiring noninvasive mechanical ventilation =3 Requiring invasive mechanical ventilation = 4 Death = 5

  7, 14 and 28 days after randomization

Secondary Outcomes (1)

• Mortality at day 28; frequency of invasive mechanical ventilation; duration of oxygen therapy; duration of hospital admission

  Within 28 days

Study Arms (2)

Convalescent Plasma

EXPERIMENTAL

Drug: Convalescent Plasma

Standard of care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Convalescent Plasma DRUG

Class: Blood product Physical Description: Opaque yellow fluid within a container labelled with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use)." Container will also be labelled with the International Society of Blood Transfusion format for Blood Components. Label will contain the expiration date and the donor identification number. Label will also contain information pertaining to the ABO typing of the plasma. A copy of the IBST identifier will be placed with the patient chart. Manufacture: Plasma will be collected via apheresis via collaboration with American Blood Bank Corporation, a FDA-registered blood establishment. The donors will be screened in accordance with the FDA guidance for donor eligibility for COVID-19:

Convalescent Plasma

Standard of Care OTHER

Standard of care treatment for hospitalized COVID-19 patients

Standard of care

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the participating acute care facilities as listed above (Larkin Palm Springs Hospital, Larkin South Miami Hospital) AND enrolled in the trial within 48 hours of hospital admission (defined by when admission order was placed) AND
• Age ≥ 40 with at least one of the following comorbidities (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, pulmonary hypertension, idiopathic pulmonary fibrosis, asthma, COPD, cancer, HIV/AIDS, chronic kidney disease, immunosuppression, obesity). OR
• Age ≥ 65 years of age with or without comorbid conditions. AND
• Severe or life-threatening COVID-19 disease as defined by the FDA:
• "Severe disease is defined as one or more of the following: shortness of breath (dyspnea), respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, lung infiltrates \> 50% within 24 to 48 hours, Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure AND
• Positive COVID-19 test via nasopharyngeal or pharyngeal PCR.
• Able to consent to treatment

You may not qualify if:

• Unable to consent
• Lack of laboratory confirmed COVID-19 infection.
• Hospice/Palliative care
• Unable to tolerate 200mL of fluid.
• History of IgA deficiency (due to risk of reaction)
• History of anaphylactoid or other severe reaction to plasma or blood products.
• Philosophical/Religious objections to receiving blood products.
• Pregnant or breastfeeding

Sponsors & Collaborators

• Larkin Community Hospital: lead

Study Sites (1)

Larkin Community Hospital

South Miami, Florida, 33143, United States

Location

Related Publications (2)

• Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7. No abstract available.

  PMID: 32043983 BACKGROUND

• Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020 May 21;382(21):2049-2055. doi: 10.1056/NEJMsb2005114. Epub 2020 Mar 23. No abstract available.

  PMID: 32202722 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: October 16, 2023
• Study Start: May 12, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)