Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients.

NCT04372979 | Terminated Phase 3 DMC

• 1 other identifier: 2020-A01166-33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

COVID-19 (Corona Virus Disease 2019) hospitalized patients evolution is marked by the risk of worsening of the respiratory system during the second week of the disease. To date, treatments are currently being evaluated and none of them have shown to be effective in the care of these patients. The use of convalescent plasma is a passive immunotherapy. It has often been used in respiratory virus epidemic situations (during the 1918 or 2009 influenza pandemic, or during SARS-CoV-1 or MERS-CoV pandemic). Effects reported in literature are in favour of a beneficial impact of transfusion of these plasma without serious adverse effects reported. PlasCoSSA is a randomized, controlled, triple-blinded, parallel clinical trial. This study tests the efficacy of convalescent plasma transfusion therapy in the early care of COVID-19 hospitalized patients outside intensive care units.

Conditions

COVID-19

Keywords

SARS-CoV-2; COVID 19; Convalescent plasma

Outcome Measures

Primary Outcomes (1)

• Survival time without needs of a ventilator.

  Survival time without needs of ventilator, i.e. the time until oxygen supply (patient previously in ambient air), or an increase by more than 6L/min of O2 for more than 24 hours, or the use of non-invasive ventilation, or intubation, or death.

  Day 30

Secondary Outcomes (12)

• Morbidity

  Day 15

• Morbidity

  Day 30

• Mortality

  Day 30

• Length of stay

  Day 30

• Effect on viral pharyngeal specimen clearance

  At inclusion and Day 7

Study Arms (2)

SARS-CoV-2 patients treated with convalescent plasma

EXPERIMENTAL

Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.

Drug: Transfusion of SARS-CoV-2 Convalescent Plasma.

SARS-CoV-2 patients treated with standard plasma

ACTIVE COMPARATOR

Subjects will receive an intravenous injection of standard Plasma.

Drug: Transfusion of standard Plasma.

Interventions

Transfusion of SARS-CoV-2 Convalescent Plasma. DRUG

2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.

SARS-CoV-2 patients treated with convalescent plasma

Transfusion of standard Plasma. DRUG

2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.

SARS-CoV-2 patients treated with standard plasma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90 years ;
• COVID-19 confirmed case ;
• Cases showing respiratory symptoms, checking at least one of the following criteria:
• Cough, dyspnea, respiratory rate \> 24 breaths/min
• Oxygen saturation \< 95% at rest in ambient air
• PaO2 \< 70mmHg
• Scanographic pulmonary compatible with COVID in the absence of any other etiology
• Risk of deterioration, checking at least one of the following comorbidity criteria :
• Chronic respiratory pathology
• Diabetes
• Cancer pathology
• Cardiovascular disease
• Chronic kidney failure
• Congenital or acquired immunodeficiency
• Cirrhosis at stage B

You may not qualify if:

• Patients admitted in intensive care within the first 6 hours of hospital care,
• Patients after 10 days from the start of symptoms
• Age \< 18 years and \> 90 years
• Long-term oxygen-dependent patients (at home),
• Decompensated chronic cardiac, respiratory, urological pathology
• Patient refusing administration of blood products,
• Allergic reaction to plasma products,
• IgA deficiency,
• Contraindication to transfusion
• Ig transfusion within 30 days,
• Patient currently participating to another clinical trial,
• Pregnant women,
• No affiliated to the social security,
• Person deprived of liberty by a legal or administrative decision, person under guardianship

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead
• University Hospital, Grenoble: collaborator

Study Sites (4)

HIA Percy

Clamart, 92140, France

Location

HIA Laveran

Marseille, 13013, France

Location

HIA Bégin

Saint-Mandé, 94160, France

Location

HIA Sainte Anne

Toulon, 83000, France

Location

Related Publications (47)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, Kim BT, Kim SJ. Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19). J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011.

  PMID: 32238757 BACKGROUND

• Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

  PMID: 32219428 BACKGROUND

• Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.

  PMID: 32243945 BACKGROUND

• Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020 Apr 16;181(2):281-292.e6. doi: 10.1016/j.cell.2020.02.058. Epub 2020 Mar 9.

  PMID: 32155444 BACKGROUND

• Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.

  PMID: 16121363 BACKGROUND

• Subbarao K, McAuliffe J, Vogel L, Fahle G, Fischer S, Tatti K, Packard M, Shieh WJ, Zaki S, Murphy B. Prior infection and passive transfer of neutralizing antibody prevent replication of severe acute respiratory syndrome coronavirus in the respiratory tract of mice. J Virol. 2004 Apr;78(7):3572-7. doi: 10.1128/jvi.78.7.3572-3577.2004.

  PMID: 15016880 BACKGROUND

• Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.

  PMID: 29923831 BACKGROUND

• Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.

  PMID: 32198501 BACKGROUND

• Thevarajan I, Nguyen THO, Koutsakos M, Druce J, Caly L, van de Sandt CE, Jia X, Nicholson S, Catton M, Cowie B, Tong SYC, Lewin SR, Kedzierska K. Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19. Nat Med. 2020 Apr;26(4):453-455. doi: 10.1038/s41591-020-0819-2. No abstract available.

  PMID: 32284614 BACKGROUND

• Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26. No abstract available.

  PMID: 32103284 BACKGROUND

• To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.

  PMID: 32213337 BACKGROUND

• Liu L, Wei Q, Lin Q, Fang J, Wang H, Kwok H, Tang H, Nishiura K, Peng J, Tan Z, Wu T, Cheung KW, Chan KH, Alvarez X, Qin C, Lackner A, Perlman S, Yuen KY, Chen Z. Anti-spike IgG causes severe acute lung injury by skewing macrophage responses during acute SARS-CoV infection. JCI Insight. 2019 Feb 21;4(4):e123158. doi: 10.1172/jci.insight.123158. eCollection 2019 Feb 21.

  PMID: 30830861 BACKGROUND

• Tirado SM, Yoon KJ. Antibody-dependent enhancement of virus infection and disease. Viral Immunol. 2003;16(1):69-86. doi: 10.1089/088282403763635465.

  PMID: 12725690 BACKGROUND

• Chaichana P, Okabayashi T, Puiprom O, Sasayama M, Sasaki T, Yamashita A, Ramasoota P, Kurosu T, Ikuta K. Low levels of antibody-dependent enhancement in vitro using viruses and plasma from dengue patients. PLoS One. 2014 Mar 18;9(3):e92173. doi: 10.1371/journal.pone.0092173. eCollection 2014.

  PMID: 24642752 BACKGROUND

• Houser KV, Broadbent AJ, Gretebeck L, Vogel L, Lamirande EW, Sutton T, Bock KW, Minai M, Orandle M, Moore IN, Subbarao K. Enhanced inflammation in New Zealand white rabbits when MERS-CoV reinfection occurs in the absence of neutralizing antibody. PLoS Pathog. 2017 Aug 17;13(8):e1006565. doi: 10.1371/journal.ppat.1006565. eCollection 2017 Aug.

  PMID: 28817732 BACKGROUND

• van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

  PMID: 26735992 BACKGROUND

• Dufour-Gaume F, Delaune D, Martinaud C, Sailliol A. Early and repeated use of plasma for the management of Ebola patients: Reflection around a case. Transfus Clin Biol. 2017 Feb;24(1):5-8. doi: 10.1016/j.tracli.2016.08.005. Epub 2016 Sep 14.

  PMID: 27640108 BACKGROUND

• Tirumalai RS, Chan KC, Prieto DA, Issaq HJ, Conrads TP, Veenstra TD. Characterization of the low molecular weight human serum proteome. Mol Cell Proteomics. 2003 Oct;2(10):1096-103. doi: 10.1074/mcp.M300031-MCP200. Epub 2003 Aug 13.

  PMID: 12917320 BACKGROUND

• Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

  PMID: 32073213 BACKGROUND

• Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198. No abstract available.

  PMID: 32119647 BACKGROUND

• Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.

  PMID: 30044935 BACKGROUND

• Chen L, Li X, Chen M, Feng Y, Xiong C. The ACE2 expression in human heart indicates new potential mechanism of heart injury among patients infected with SARS-CoV-2. Cardiovasc Res. 2020 May 1;116(6):1097-1100. doi: 10.1093/cvr/cvaa078. Erratum In: Cardiovasc Res. 2020 Oct 1;116(12):1994. doi: 10.1093/cvr/cvaa157.

  PMID: 32227090 BACKGROUND

• Recalcati S. Cutaneous manifestations in COVID-19: a first perspective. J Eur Acad Dermatol Venereol. 2020 May;34(5):e212-e213. doi: 10.1111/jdv.16387. No abstract available.

  PMID: 32215952 BACKGROUND

• Wu F, Peng Z, Park PW, Kozar RA. Loss of Syndecan-1 Abrogates the Pulmonary Protective Phenotype Induced by Plasma After Hemorrhagic Shock. Shock. 2017 Sep;48(3):340-345. doi: 10.1097/SHK.0000000000000832.

  PMID: 28107214 BACKGROUND

• Whitney JE, Zhang B, Koterba N, Chen F, Bush J, Graham K, Lacey SF, Melenhorst JJ, Teachey DT, Mensinger JL, Yehya N, Weiss SL. Systemic Endothelial Activation Is Associated With Early Acute Respiratory Distress Syndrome in Children With Extrapulmonary Sepsis. Crit Care Med. 2020 Mar;48(3):344-352. doi: 10.1097/CCM.0000000000004091.

  PMID: 32058372 BACKGROUND

• Garraud O, Heshmati F, Pozzetto B, Lefrere F, Girot R, Saillol A, Laperche S. Plasma therapy against infectious pathogens, as of yesterday, today and tomorrow. Transfus Clin Biol. 2016 Feb;23(1):39-44. doi: 10.1016/j.tracli.2015.12.003. Epub 2016 Jan 6.

  PMID: 26775794 BACKGROUND

• Dinsdale RJ, Hazeldine J, Al Tarrah K, Hampson P, Devi A, Ermogenous C, Bamford AL, Bishop J, Watts S, Kirkman E, Dalle Lucca JJ, Midwinter M, Woolley T, Foster M, Lord JM, Moiemen N, Harrison P. Dysregulation of the actin scavenging system and inhibition of DNase activity following severe thermal injury. Br J Surg. 2020 Mar;107(4):391-401. doi: 10.1002/bjs.11310. Epub 2019 Sep 10.

  PMID: 31502663 BACKGROUND

• Squizzato A, Hunt BJ, Kinasewitz GT, Wada H, Ten Cate H, Thachil J, Levi M, Vicente V, D'Angelo A, Di Nisio M. Supportive management strategies for disseminated intravascular coagulation. An international consensus. Thromb Haemost. 2016 May 2;115(5):896-904. doi: 10.1160/TH15-09-0740. Epub 2015 Dec 17.

  PMID: 26676927 BACKGROUND

• Di Nisio M, Thachil J, Squizzato A. Management of disseminated intravascular coagulation: a survey of the International Society on Thrombosis and Haemostasis. Thromb Res. 2015 Aug;136(2):239-42. doi: 10.1016/j.thromres.2015.05.022. Epub 2015 May 23.

  PMID: 26033399 BACKGROUND

• Garraud O, Malot S, Herbrecht R, Ojeda-Uribe M, Lin JS, Veyradier A, Payrat JM, Liu K, Corash L, Coppo P. Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2019 Dec;58(6):102665. doi: 10.1016/j.transci.2019.10.007. Epub 2019 Nov 5.

  PMID: 31740165 BACKGROUND

• van Griensven J, De Weiggheleire A, Delamou A, Smith PG, Edwards T, Vandekerckhove P, Bah EI, Colebunders R, Herve I, Lazaygues C, Haba N, Lynen L. The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource-Constrained Settings: A Perspective From the Field. Clin Infect Dis. 2016 Jan 1;62(1):69-74. doi: 10.1093/cid/civ680. Epub 2015 Aug 10.

  PMID: 26261205 BACKGROUND

• Brown JF, Dye JM, Tozay S, Jeh-Mulbah G, Wohl DA, Fischer WA 2nd, Cunningham CK, Rowe K, Zacharias P, van Hasselt J, Norwood DA, Thielman NM, Zak SE, Hoover DL. Anti-Ebola Virus Antibody Levels in Convalescent Plasma and Viral Load After Plasma Infusion in Patients With Ebola Virus Disease. J Infect Dis. 2018 Jul 13;218(4):555-562. doi: 10.1093/infdis/jiy199.

  PMID: 29659889 BACKGROUND

• Di Minno G, Navarro D, Perno CF, Canaro M, Gurtler L, Ironside JW, Eichler H, Tiede A. Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients? Ann Hematol. 2017 Aug;96(8):1253-1270. doi: 10.1007/s00277-017-3028-4. Epub 2017 Jun 18.

  PMID: 28624906 BACKGROUND

• Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.

  PMID: 32281317 BACKGROUND

• Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

  PMID: 32253318 BACKGROUND

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

• Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.

  PMID: 15616839 BACKGROUND

• Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

  PMID: 15214887 BACKGROUND

• Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.

  PMID: 25030060 BACKGROUND

• Shi Y, Wang Y, Shao C, Huang J, Gan J, Huang X, Bucci E, Piacentini M, Ippolito G, Melino G. COVID-19 infection: the perspectives on immune responses. Cell Death Differ. 2020 May;27(5):1451-1454. doi: 10.1038/s41418-020-0530-3. Epub 2020 Mar 23. No abstract available.

  PMID: 32205856 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Chang L, Yan Y, Wang L. Coronavirus Disease 2019: Coronaviruses and Blood Safety. Transfus Med Rev. 2020 Apr;34(2):75-80. doi: 10.1016/j.tmrv.2020.02.003. Epub 2020 Feb 21.

  PMID: 32107119 BACKGROUND

• Hashem AM, Hassan AM, Tolah AM, Alsaadi MA, Abunada Q, Damanhouri GA, El-Kafrawy SA, Picard-Maureau M, Azhar EI, Hindawi SI. Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates. Transfus Med. 2019 Dec;29(6):434-441. doi: 10.1111/tme.12638. Epub 2019 Nov 6.

  PMID: 31696565 BACKGROUND

• Lin L, Hanson CV, Alter HJ, Jauvin V, Bernard KA, Murthy KK, Metzel P, Corash L. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion. 2005 Apr;45(4):580-90. doi: 10.1111/j.0041-1132.2005.04316.x.

  PMID: 15819680 BACKGROUND

• Chang L, Zhao L, Gong H, Wang L, Wang L. Severe Acute Respiratory Syndrome Coronavirus 2 RNA Detected in Blood Donations. Emerg Infect Dis. 2020 Jul;26(7):1631-1633. doi: 10.3201/eid2607.200839. Epub 2020 Jun 21.

  PMID: 32243255 BACKGROUND

Related Links

• Anticoagulant treatment for the prevention of thrombotic risk in a patient hospitalized with COVID-19 and monitoring of hemostasis.
• Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19 - Full Text View - ClinicalTrials.gov
• Transfusion of therapeutic plasma: products, indications (Haute Autorité de Santé, France)
• Coronavirus SARS-CoV-2 management of people at risk of severe forms (Haut Conseil de la Santé Publique; 2020)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nathalie KOULMANN

  Direction Centrale du Service de Santé des Armées (DCSSA)

  STUDY DIRECTOR

• Catherine VERRET

  Service de Santé des Armées-Direction de la Formation de la Recherche et de l'Innovation

  STUDY DIRECTOR

• Christophe MARTINAUD

  Centre de Transfusion Sanguine des Armées

  PRINCIPAL INVESTIGATOR

• Jean-Luc BOSSON

  Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: September 14, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)