Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Summary
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
Timeline
- Start
- 2020-06-03
- Primary completion
- 2022-01-14
- Completion
- 2022-12-14
Outcome
Mixed primary results
registry COUNT_OF_PARTICIPANTS SARS-CoV-2 Convalescent Plasma: 17 Participants COUNT_OF_PARTICIPANTS Standard Control Plasma: 37 Participants NCT04373460 ↗
registry analysis (superiority test); SARS-CoV-2 Convalescent Plasma vs Standard Control Plasma; p = 0.005; Risk Difference (RD) 3.4 (95% CI 1.0 to 5.8); Fisher Exact NCT04373460 ↗
registry NUMBER SARS-CoV-2 Convalescent Plasma: 0.25 Rate per person-years NUMBER Standard Control Plasma: 0.43 Rate per person-years analysis (superiority test); SARS-CoV-2 Convalescent Plasma vs Standard Control Plasma; p = 0.02 NCT04373460 ↗
registry analysis (superiority test); SARS-CoV-2 Convalescent Plasma vs Standard Control Plasma; p = 0.16; Risk Difference (RD) -0.05 (95% CI -0.11 to 0.02); Rate per person-years NCT04373460 ↗
registry analysis (superiority test); SARS-CoV-2 Convalescent Plasma vs Standard Control Plasma; p = 0.32; Risk Difference (RD) 0.01 (95% CI -0.01 to 0.02); Rate per person-years NCT04373460 ↗
Publications
- Results Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv [Preprint]. 2021 Dec 21:2021.12.10.21267485. doi: 10.1101/2021.12.10.21267485.
- Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. JCI Insight. 2024 Mar 14;9(8):e178460. doi: 10.1172/jci.insight.178460.
- Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AAR, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. medRxiv [Preprint]. 2023 Dec 15:2023.04.13.23288353. doi: 10.1101/2023.04.13.23288353.
- Baksh SN, Heath SL, Fukuta Y, Shade D, Meisenberg B, Bloch EM, Tobian AAR, Spivak ES, Patel B, Gerber J, Raval JS, Forthal D, Paxton J, Mosnaim G, Anjan S, Blair J, Cachay E, Currier J, Das P, Huaman M, Sutcliffe C, Yarava A, Casadevall A, Sullivan D, Hanley D, Gebo KA. Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial. J Infect Dis. 2023 May 29;227(11):1266-1273. doi: 10.1093/infdis/jiad023.
- Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SARS-CoV-2 convalescent plasma | Protein / enzyme biologic | 175 ml | Other |