Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2025.02.002, ACTIV-3/TICO, NCT04501978, Feb 2025
41st treatment shown to reduce risk in
May 2022, now with p = 0.0066 from 19 studies, recognized in 33 countries.
Efficacy is variant dependent.
No treatment is 100% effective. Protocols
combine treatments.
6,300+ studies for
210+ treatments. c19early.org
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Analysis of 2,311 hospitalized COVID-19 patients from four randomized controlled trials (ACTIV-3/TICO) showing no significant difference in long-term mortality with sotrovimab, amubarvimab/romlusevimab, tixagevimab-cilgavimab, or ensovibep.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, BQ.1.11, BA.5, BA.2.75, XBB2,3, XBB.1.53, ХВВ.1.9.13, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.14.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments5.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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risk of death, 23.0% lower, HR 0.77, p = 0.08, treatment 80 of 710 (11.3%), control 101 of 707 (14.3%), NNT 33, Cox proportional hazards, day 540.
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risk of death/hospitalization, 3.0% lower, HR 0.97, p = 0.77, treatment 212 of 710 (29.9%), control 213 of 707 (30.1%), NNT 373, Cox proportional hazards, day 540.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
1.
Planas et al., Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies, bioRxiv, doi:10.1101/2022.11.17.516888.
2.
Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.
3.
Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.
Mourad et al., 6 Feb 2025, Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, median age 57.0, 30 authors, study period 16 December, 2020 - 15 November, 2021, trial NCT04501978 (history) (ACTIV-3/TICO).
Contact: thomas.holland@duke.edu.
Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2025.02.002
Objectives: Passive immunotherapy, including monoclonal antibodies and neutralizing proteins, was used for the treatment of patients with COVID-19 during the pandemic. Accelerating COVID-19 Therapeutic Interventions and VaccineseTherapeutics for Inpatients with COVID-19 (ACTIV-3/TICO) was a multinational, randomized placebo-controlled platform trial that evaluated the effectiveness of multiple passive immunotherapy agents in patients hospitalized with COVID-19. Given the long half-life of some agents studied, participants were followed for an extended period to assess the long-term efficacy and sustained safety of these agents. Methods: We conducted a pooled analysis of individual participant data from four trials of ACTIV-3/TICO: sotrovimab, amubarvimaberomlusevimab, tixagevimabecilgavimab, and ensovibep. Cox proportional hazards models were conducted to compare time to mortality and time to mortality or rehospitalization between participants receiving active agents vs. placebo through 18 months. Results: A total of 2311 participants were enrolled between 16 December 2020 and 15 November 2021. Overall, 56.9% (1315/2311) received an active agent and 77.2% (1784/2311) of participants were unvaccinated for SARS-CoV-2. Median duration between symptom onset and enrolment was 8 days (interquartile range, 6e10), and most participants received remdesivir (92.1% [2129/2311]) and corticosteroids (70.4% [1627/2311]) before enrolment. There was no difference in mortality across all active (11.9% [157/ 1315]) vs. placebo (14.0% [139/996]) arms (hazard ratio, 0.87; 95% CI, 0.70e1.08). Furthermore, there was no difference in combined mortality or rehospitalization across all active (31.7% [417/1315]) vs. placebo (32.1% [320/996]) arms (hazard ratio, 0.96; 95% CI, 0.84e1.10). Discussion: In our large study of long half-life passive immunotherapy for hospitalized patients with COVID-19, we did not find evidence of a long-term effect on either mortality or rehospitalization.
Author contributions A.M. and T.L.H. had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. A.M., G.A.G., L.K.S., N.E., R.P., W.H.S., J.L., and T.L.H. were responsible for the concept and design and were also responsible for the acquisition, analysis, or interpretation of data. G.A.G., L.K.S., and N.E. were responsible for the statistical analysis. A.M., G.A.G., L.K.S., N.E., and T.L.H. were responsible for the drafting of the manuscript. All authors were responsible for the critical review of the manuscript for important intellectual content.
Transparency declaration Potential conflict of interest M.J. received grant support from Gilead Sciences, Laurent Pharmaceuticals, and AbbVie. K.K. received grant support from Astra Zeneca, Pfizer, Regeneron, and National Institutes of Health; Author: Sanford Guide. J.J.M. received honoraria and/or speakers fees from Astra Zeneca, Gilead Sciences, Merck Sharp & Dohme and travel or congress reimbursements from Gilead Sciences. G.M. received funding from NHMCR Investigator Award. R.P. received advisory boards support from Gilead Sciences, Inc, Pfizer, Inc, Roche Therapeutics, MSD, GSK, ViiV Healthcare, Eli Lilly and Company, Astra Zeneca, Exevir, PharmaMar, and Atea Pharmaceuticals, Inc., and grant support from MSD, ViiV Healthcare, Gilead Sciences, and PharmaMar. B.E.Y. received honoraria and/or speakers fees from AstraZeneca, Gilead, Moderna, Pfizer,..
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Late treatment
is less effective
is less effective
mourad