Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia
et al., JAMA, doi:10.1001/jama.2023.11043, ACTIV-1 IM, NCT04593940, Jul 2023
RCT 723 hospitalized COVID-19 patients showing no significant difference in outcomes with cenicriviroc treatment.
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risk of death, 30.2% higher, RR 1.30, p = 0.15, treatment 64 of 355 (18.0%), control 49 of 354 (13.8%), day 60.
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risk of death, 16.3% higher, RR 1.16, p = 0.50, treatment 49 of 355 (13.8%), control 42 of 354 (11.9%), day 28.
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risk of no improvement, 7.5% higher, OR 1.08, p = 0.62, treatment 348, control 343, inverted to make OR<1 favor treatment, clinical status, day 14, RR approximated with OR.
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risk of no recovery, 1.0% lower, RR 0.99, p = 0.91, treatment 360, control 363, inverted to make RR<1 favor treatment, day 28.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
O’Halloran et al., 25 Jul 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, mean age 54.8, 51 authors, study period 16 October, 2020 - 31 December, 2021, average treatment delay 9.8 days, trial NCT04593940 (history) (ACTIV-1 IM).
Contact: jrutter@nih.gov, cschmitt@niaid.nih.gov, mkurilla@niaid.nih.gov.
Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia
JAMA, doi:10.1001/jama.2023.11043
IMPORTANCE Immune dysregulation contributes to poorer outcomes in COVID-19. OBJECTIVE To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021. INTERVENTIONS Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day).
MAIN OUTCOMES AND MEASURES The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale.
RESULTS Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28]; P = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; P = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; P = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies. CONCLUSIONS AND RELEVANCE Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo.
Role of the Funder/Sponsor: Janssen provided infliximab, Bristol Myers Squibb provided abatacept, and AbbVie provided cenicriviroc for use in this trial but did not provide any financial support. Gilead Sciences provided remdesivir for use in this trial but did not provide any financial support. Employees of Janssen and Gilead Sciences participated in discussions about protocol development and in weekly protocol team calls. The final trial protocol was developed by the protocol chair, Dr William Powderly, the IND sponsor Dr Daniel K. Benjamin Jr, and a protocol development committee including representatives from the National Center for Advancing Translational Sciences (NCATS). NCATS had a collaborative role in the trial design, management, interpretation of the data and the preparation of the manuscript along with the protocol chair, the study statisticians and the study writing group.
Group Information: The ACTIV-1 IM Study Group Members are provided in Supplement 3. William Checkley, MD, PhD (Johns Hopkins University, Baltimore, MD); and Beatriz Grinsztejn, MD (Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil), for their oversight; the community advisory board, Larisa Caicedo, Ashish Cowlagi, Anna Davis, Lincoln Larmond, Doug Lindsey, Bob Pearson, and the participants and their families for their altruism in participating in this trial; Elizabeth E.S. Cook for editorial support; and Christopher J. Lindsell for contributions to the..
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DOI record:
{
"DOI": "10.1001/jama.2023.11043",
"ISSN": [
"0098-7484"
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"URL": "http://dx.doi.org/10.1001/jama.2023.11043",
"abstract": "<jats:sec><jats:title>Importance</jats:title><jats:p>Immune dysregulation contributes to poorer outcomes in COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day).</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28]; <jats:italic>P</jats:italic> = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; <jats:italic>P</jats:italic> = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; <jats:italic>P</jats:italic> = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://classic.clinicaltrials.gov/ct2/show/NCT04593940\">NCT04593940</jats:ext-link></jats:p></jats:sec>",
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Late treatment
is less effective
is less effective
