Early High-Titer Plasma Therapy to Prevent Severe COVID-19 in Older Adults - COVID-19 Plasma Therapy

Jan 08, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bill and Melinda Gates Foundation, and the Fundación INFANT Pandemic Fund
Date Published:
01/06/2021
Date Updated:
01/08/2021
Original Posted Date:
01/08/2021
References

Contribution To Literature:

This trial showed that convalescent plasma was superior to placebo at preventing development of severe respiratory disease among older adults with COVID-19 infection.

Description:

The goal of the trial was to evaluate convalescent plasma compared with placebo among patients with early mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) infection.

Study Design

  • Randomized
  • Parallel
  • Double-blind

Patients with early mild SARS-CoV-2 infection were randomized to convalescent plasma (n = 80) versus placebo (n = 80).

  • Total number of enrollees: 160
  • Duration of follow-up: 25 days
  • Mean patient age: 76 years
  • Percentage female: 68%
  • Percentage with diabetes: 29%

Inclusion criteria:

  • Reverse-transcriptase–polymerase-chain-reaction (RT-PCR)–confirmed SARS-CoV-2 infection
  • ≥75 years of age OR 65-74 years of age with one co-existing medical condition defined as hypertension, diabetes, obesity, chronic renal failure, cardiovascular disease, or chronic obstructive pulmonary disease
  • At least one of the following: temperature ≥37.5°C (99.5°F), unexplained sweating, or chills
  • At least one of the following: dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, dysgeusia, anosmia, or rhinorrhea

Exclusion criteria:

  • Severe respiratory disease

Other salient features/characteristics:

  • The trial was stopped early (76% of projected sample size)

Principal Findings:

The primary outcome, severe respiratory disease, defined as respiratory rate of ≥30 breaths/minute and/or oxygen saturation <93%, occurred in 16% of the convalescent plasma group compared with 31% of the placebo group (p = 0.03). The risk of severe respiratory disease among those who received IgG titers at or above the median concentration compared with placebo was: relative risk (RR) 0.27, 95% confidence interval (CI) 0.08-0.68, while the risk of severe respiratory disease among those who received IgG titers below the median concentration compared with placebo was: RR 0.69, 95% CI 0.34-1.31.

Secondary outcomes:

  • Mortality, life-threatening respiratory disease, or critical systemic illness: 9% of the convalescent plasma group compared with 15% of the placebo group
  • Mortality: 2% of the convalescent plasma group compared with 5% of the placebo group

Interpretation:

Among older patients with early and mild SARS-CoV-2 infection, administration of convalescent plasma appeared to be beneficial at preventing severe respiratory disease. This trial was terminated early due to problems with subject recruitment from a decrease in the prevalence of SARS-CoV-2 infection in the region. There was suggestion of enhanced benefit among those who received convalescent plasma > the median titer of 1:3200. The positive findings of this trial are different from other convalescent serum studies and might be related to enrollment of older subjects (50% of subjects ≥75 years) and earlier administration of convalescent plasma (<72 hours).

References:

Libster R, Marc GP, Wappner D, et al., on behalf of the Fundación INFANT–COVID-19 Group. Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med 2021;Jan 6:[Epub ahead of print].

Clinical Topics: COVID-19 Hub, Geriatric Cardiology, Prevention, Hypertension

Keywords: COVID-19, Diabetes Mellitus, Geriatrics, Hypertension, Immunoglobulin G, Plasma, Primary Prevention, Respiratory Insufficiency, Reverse Transcriptase Polymerase Chain Reaction, SARS Virus, severe acute respiratory syndrome coronavirus 2


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