Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial

It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long...

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Published in:EClinicalMedicine 2024-09, Vol.75, p.102787, Article 102787
Main Authors: Ritz, Justin, Li, Jonathan Z., Wohl, David, Giganti, Mark, Patel, Nilam, Colsh, Kelly, Evering, Teresa H., Ignacio, Rachel Bender, Jilg, Nikolaus, Perelson, Alan, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Gapara, Morgan, Margolis, David, Nuñez, Sebastian, Papasidero, Marcelo, Wehbe, Luis, Voena, Felicitas Fernandez, Lopez, Amaru, Huhn, Virginia, Dieser, Pablo, Mussi, Marisa, de Carvalho Santana, Rodrigo, Tiraboschi Bárbaro, Adriana Aparecida, Santos, Breno, Cardoso, Sandra Wagner, Diniz Ribeiro, Maria Pia, Vasconcellos, Eduardo, Faleiro Ferreira, Flávia Gomes, Bohorquez Lopez, Victor Casildo, Coetzer, Thomas, Madlala, Penelope, Petrick, Frederick, Mbali, Rose, Zwane, Zinhle, Chiperera, Tendai, Mohapi, Lerato, Singh, Usha, McHarry, Kirsten, Snyman, Elizma, Adonis, Tania, Sein, Ni Ni, Mitha, Ismail, Lummus, Christie, Kim, Andrew, Kao, Wei-Hsin, Pfeffer, Michael M., Arnold, Melanie, Karpf, Cinzia, Yawetz, Sigal, Keenan, Cheryl, Milstone, Aaron, Berardi, Jonathan, Arar, Celine, Gomez-Martinez, Marissa, Focil, Augusto, Rosas, Griselda, Bukhman, Eugene, Farah, Humam, Kingsley, Jeffrey, Herman, Craig, Leon, Ramon, Nikolov, Boris, Jagizarov, Zarema, Becker, Becky, Maldonado, Valarie, Veltman, Jennifer, Pullman, John, Johnson, Misty, Hecker, Michelle, Wernick, Arthur, Ruiz, Karelia, Harber, Heather, Cicarella, Robyn, Pulliam, Sallie D., Socorro, Estefania, Neytman, Gene, Aziz, Mariam, Swiatek, Joan, Hoover, Susan E., Weston, Patrick, Sullivano, Jennifer, Clemency, Brian, Khodabakhshian, Aleen, Fortier, Samantha, Rathore, Mobeen, Mahmoudi, Saniyyah, Spikes, Leslie, Hall, Chase, Loftis, Amy James, Short, William, Mendez, Luis M., Jonsson, Chris, Nakatani, Lisa, Williamson, Derrick, Atriss, Hisham, Caloura, Matthew, Presti, Rachel
Format: Article
Language:English
Subjects:
Clinical trial
COVID-19
Long COVID
Monoclonal antibodies
Outpatient treatment
Post COVID conditions
Post-acute sequelae of SARS-CoV-2 infection (PASC)
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Summary:It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.
ISSN:2589-5370
2589-5370
DOI:10.1016/j.eclinm.2024.102787