No significant difference versus placebo observed for hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen
MONDAY, Dec. 13, 2021 (HealthDay News) — For hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen, COVID-19 convalescent plasma (CCP) is not efficacious compared with placebo, according to a study published online Dec. 13 in JAMA Internal Medicine.
Mila B. Ortigoza, M.D., Ph.D., from the NYU Grossman School of Medicine in New York City, and colleagues examined the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Participants were randomly assigned to receive about 250 mL of CCP or equivalent volume of normal saline (468 and 473, respectively). The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; WHO scores determined on day 28 represented the secondary outcome.
The researchers found that the cumulative adjusted odds ratio (cOR) for the primary outcome was 0.94 (95 percent credible interval [CrI], 0.75 to 1.18, with posterior probability [P[cOR<1] of 72 percent]), adjusted for site, baseline risk, WHO score, age, sex, and symptom duration; the cOR was 0.92 (95 percent CrI, 0.74 to 1.16; P[cOR<1], 76 percent) for the secondary adjusted outcome. In exploratory subgroup analyses, heterogeneity of a treatment effect was suggested: At day 28, cORs were 0.72 (95 percent CrI, 0.46 to 1.13 P[cOR<1], 93 percent) for those enrolled in April to June 2020 and 0.65 (95 percent CrI, 0.41 to 1.02; P[cOR<1], 97 percent) for those not receiving remdesivir or corticosteroids at randomization.
“This placebo-controlled double-blind randomized clinical trial of use of CCP in hospitalized patients with COVID-19 requiring noninvasive oxygen supplementation did not meet the prespecified definition of CCP efficacy,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
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