Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
NCT ID: NCT04345289
Last Updated: 2022-08-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
147 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-01
Study Completion Date
2021-03-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19.
Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo.
Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo.
Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Convalescent Plasma for Treatment of COVID-19
NCT04649879
Covid19
COMPLETED
PHASE2/PHASE3
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
NCT04397757
COVID-19
COMPLETED
PHASE1
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)
NCT04390178
COVID-19
COMPLETED
PHASE1/PHASE2
Use of Convalescent Plasma for COVID-19
NCT04408040
COVID
TERMINATED
PHASE2
Convalescent Plasma for Early Treatment of COVID-19
NCT04390503
SARS-CoV 2
COVID-19
TERMINATED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.
The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.
As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.
The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.
As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
COVID
Corona Virus Infection
Viral Pneumonia
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Adaptive multi-arm trial comparing convalescent plasma against control group. Interim analyses are included at 300 and 700 included participants to compare the effect and safety of the experimental treatment to control (placebo). The results of the interim analyses are used to decide if the treatments should be discontinued due to either futility or harm. The study is discontinued if either of the predefined stopping criteria are met.
Additional experimental treatments may be added as they become available. Any efficacious treatment identified in this or any other high-quality RCT may become the new SOC after consensus by national and international societies, and, thus, the control arm will change accordingly and in parallel.
Additional experimental treatments may be added as they become available. Any efficacious treatment identified in this or any other high-quality RCT may become the new SOC after consensus by national and international societies, and, thus, the control arm will change accordingly and in parallel.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Both convalescent plasma and placebo will be administered via a colored intravenous line with a colored sleeve disguising the fluid bag.
In order to achieve blinding of participants and treating personnel, patients randomized to active treatment will also receive placebo treatment.
In order to achieve blinding of participants and treating personnel, patients randomized to active treatment will also receive placebo treatment.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Convalescent plasma
Will receive active treatment with convalescent anti-SARS-CoV-2 plasma (600 ml) as a single dose iv infusion in addition to standard care.
Group Type
ACTIVE_COMPARATOR
Convalescent anti-SARS-CoV-2 plasma
Intervention Type
BIOLOGICAL
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Infusion placebo
Will receive placebo treatment with saline 0.9% (2 x 300 ml) as an iv single dose infusion in addition to standard care.
Group Type
PLACEBO_COMPARATOR
Infusion placebo
Intervention Type
OTHER
Saline 0.9% (600 ml) as an iv single dose infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Convalescent anti-SARS-CoV-2 plasma
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Intervention Type
BIOLOGICAL
Infusion placebo
Saline 0.9% (600 ml) as an iv single dose infusion
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Convalescent plasma
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥18 years of age
* Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
* Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 \<300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
* For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
* Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives
* Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
* Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 \<300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
* For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
* Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives
Exclusion Criteria
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
* Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)\*
* Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)\*
* Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Thomas Benfield
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Benfield
Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandra Hansen, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Simone Bastrup Israelsen, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Louise Thorlacius-Ussing, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Karen Brorup Heje Pedersen, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Clara Clausen, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Michaela Tinggaard, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Nichlas Hovmand, MD
Role: STUDY_DIRECTOR
Hvidovre University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aalborg University Hospital
Aalborg, , Denmark
Site Status
Aarhus University Hospital
Aarhus, , Denmark
Site Status
Bispebjerg Hospital
Copenhagen, , Denmark
Site Status
Rigshospitalet
Copenhagen, , Denmark
Site Status
Herlev Gentofte Hospital
Herlev, , Denmark
Site Status
Herning Hospital
Herning, , Denmark
Site Status
Nordsjællands Hospital
Hillerød, , Denmark
Site Status
Hvidovre Hospital
Hvidovre, , Denmark
Site Status
Kolding Hospital
Kolding, , Denmark
Site Status
Odense University Hospital
Odense, , Denmark
Site Status
Roskilde Hospital
Roskilde, , Denmark
Site Status
Vejle Hospital
Vejle, , Denmark
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Denmark
References
Explore related publications, articles, or registry entries linked to this study.
Infection prevention and control in the context of coronavirus disease 2019 (COVID-19): a living guideline [Internet]. Geneva: World Health Organization; 2022 Apr 25-. Available from http://www.ncbi.nlm.nih.gov/books/NBK581594/
Reference Type
BACKGROUND
Cameron MJ, Bermejo-Martin JF, Danesh A, Muller MP, Kelvin DJ. Human immunopathogenesis of severe acute respiratory syndrome (SARS). Virus Res. 2008 Apr;133(1):13-9. doi: 10.1016/j.virusres.2007.02.014. Epub 2007 Mar 19.
Reference Type
BACKGROUND
Matthay MA, Ware LB, Zimmerman GA. The acute respiratory distress syndrome. J Clin Invest. 2012 Aug;122(8):2731-40. doi: 10.1172/JCI60331. Epub 2012 Aug 1.
Reference Type
BACKGROUND
Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
Reference Type
BACKGROUND
Li Y, Chen M, Cao H, Zhu Y, Zheng J, Zhou H. Extraordinary GU-rich single-strand RNA identified from SARS coronavirus contributes an excessive innate immune response. Microbes Infect. 2013 Feb;15(2):88-95. doi: 10.1016/j.micinf.2012.10.008. Epub 2012 Oct 30.
Reference Type
BACKGROUND
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
Reference Type
BACKGROUND
Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
Reference Type
BACKGROUND
Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
Reference Type
BACKGROUND
Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12.
Reference Type
BACKGROUND
Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.
Reference Type
BACKGROUND
Wu D, Yang XO. TH17 responses in cytokine storm of COVID-19: An emerging target of JAK2 inhibitor Fedratinib. J Microbiol Immunol Infect. 2020 Jun;53(3):368-370. doi: 10.1016/j.jmii.2020.03.005. Epub 2020 Mar 11.
Reference Type
BACKGROUND
Stebbing J, Phelan A, Griffin I, Tucker C, Oechsle O, Smith D, Richardson P. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet Infect Dis. 2020 Apr;20(4):400-402. doi: 10.1016/S1473-3099(20)30132-8. Epub 2020 Feb 27. No abstract available.
Reference Type
BACKGROUND
Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
Reference Type
BACKGROUND
Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6. No abstract available.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
Reference Type
BACKGROUND
Zhang Y, Li J, Zhan Y, Wu L, Yu X, Zhang W, Ye L, Xu S, Sun R, Wang Y, Lou J. Analysis of serum cytokines in patients with severe acute respiratory syndrome. Infect Immun. 2004 Aug;72(8):4410-5. doi: 10.1128/IAI.72.8.4410-4415.2004.
Reference Type
BACKGROUND
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Reference Type
BACKGROUND
Pelechas E, Voulgari PV, Drosos AA. Clinical evaluation of the safety, efficacy and tolerability of sarilumab in the treatment of moderate to severe rheumatoid arthritis. Ther Clin Risk Manag. 2019 Sep 4;15:1073-1079. doi: 10.2147/TCRM.S167452. eCollection 2019.
Reference Type
BACKGROUND
Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69. doi: 10.1186/1743-422X-2-69.
Reference Type
BACKGROUND
Klumperman J, Locker JK, Meijer A, Horzinek MC, Geuze HJ, Rottier PJ. Coronavirus M proteins accumulate in the Golgi complex beyond the site of virion budding. J Virol. 1994 Oct;68(10):6523-34. doi: 10.1128/JVI.68.10.6523-6534.1994.
Reference Type
BACKGROUND
Gay B, Bernard E, Solignat M, Chazal N, Devaux C, Briant L. pH-dependent entry of chikungunya virus into Aedes albopictus cells. Infect Genet Evol. 2012 Aug;12(6):1275-81. doi: 10.1016/j.meegid.2012.02.003. Epub 2012 Feb 20.
Reference Type
BACKGROUND
multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia. [Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009. Chinese.
Reference Type
BACKGROUND
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
Reference Type
BACKGROUND
Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.
Reference Type
BACKGROUND
Jaki T, Wason JMS. Multi-arm multi-stage trials can improve the efficiency of finding effective treatments for stroke: a case study. BMC Cardiovasc Disord. 2018 Nov 27;18(1):215. doi: 10.1186/s12872-018-0956-4.
Reference Type
BACKGROUND
Cordon-Cardo C, Lloyd KO, Finstad CL, McGroarty ME, Reuter VE, Bander NH, Old LJ, Melamed MR. Immunoanatomic distribution of blood group antigens in the human urinary tract. Influence of secretor status. Lab Invest. 1986 Oct;55(4):444-54.
Reference Type
BACKGROUND
Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
Reference Type
BACKGROUND
Distler P. ISBT 128: a global information standard. Cell Tissue Bank. 2010 Nov;11(4):365-73. doi: 10.1007/s10561-010-9196-2. Epub 2010 Jul 21.
Reference Type
BACKGROUND
Clegg DO, Dietz F, Duffy J, Willkens RF, Hurd E, Germain BF, Wall B, Wallace DJ, Bell CL, Sleckman J. Safety and efficacy of hydroxychloroquine as maintenance therapy for rheumatoid arthritis after combination therapy with methotrexate and hydroxychloroquine. J Rheumatol. 1997 Oct;24(10):1896-902.
Reference Type
BACKGROUND
Middelburg RA, Van Stein D, Zupanska B, Uhrynowska M, Gajic O, Muniz-Diaz E, Galvez NN, Silliman CC, Krusius T, Wallis JP, Vandenbroucke JP, Briet E, Van Der Bom JG. Female donors and transfusion-related acute lung injury: A case-referent study from the International TRALI Unisex Research Group. Transfusion. 2010 Nov;50(11):2447-54. doi: 10.1111/j.1537-2995.2010.02715.x.
Reference Type
BACKGROUND
Lamb YN, Deeks ED. Sarilumab: A Review in Moderate to Severe Rheumatoid Arthritis. Drugs. 2018 Jun;78(9):929-940. doi: 10.1007/s40265-018-0929-z.
Reference Type
BACKGROUND
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
Reference Type
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.
Reference Type
BACKGROUND
Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
Reference Type
BACKGROUND
Thorlacius-Ussing L, Brooks PT, Nielsen H, Jensen BA, Wiese L, Saekmose SG, Johnsen S, Gybel-Brask M, Johansen IS, Bruun MT, Staerke NB, Ostergaard L, Erikstrup C, Ostrowski SR, Homburg KM, Georgsen J, Mikkelsen S, Sandholdt H, Leding C, Hovmand N, Clausen CL, Tinggaard M, Pedersen KBH, Iversen KK, Tingsgard S, Israelsen SB, Benfield T. A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia. Sci Rep. 2022 Sep 30;12(1):16385. doi: 10.1038/s41598-022-19629-z.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-001367-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
25032020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia
NCT04374565
COMPLETED
PHASE2
Convalescent Plasma for the Treatment of COVID-19
NCT04389710
COMPLETED
PHASE2
Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)
NCT04554992
UNKNOWN
PHASE1
Convalescent Plasma to Limit Coronavirus Associated Complications
NCT04325672
WITHDRAWN
PHASE2
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
NCT04388527
COMPLETED
PHASE1
Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure
NCT04428021
COMPLETED
PHASE2
Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
NCT04361253
TERMINATED
PHASE3
Convalescent Plasma vs. Standard Plasma for COVID-19
NCT04344535
TERMINATED
PHASE1/PHASE2
Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19
NCT04393727
TERMINATED
PHASE2
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
NCT04364737
COMPLETED
PHASE2
Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
NCT04360486
NO_LONGER_AVAILABLE
Plasma Therapy of COVID-19 in Severely Ill Patients
NCT04359810
COMPLETED
PHASE2
Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients
NCT04354831
COMPLETED
PHASE2
COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients
NCT04474340
UNKNOWN
PHASE1
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
NCT04373460
COMPLETED
PHASE2
Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19
NCT04292340
UNKNOWN
Convalescent Plasma in the Treatment of Covid-19
NCT04600440
UNKNOWN
NA
Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
NCT04516811
UNKNOWN
PHASE3
Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness
NCT04642014
TERMINATED
NA
Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
NCT04384497
COMPLETED
PHASE1/PHASE2
Efficacy of Convalescent Plasma Therapy in Patients With COVID-19
NCT04425915
COMPLETED
PHASE3
Convalescent Plasma in Outpatients With COVID-19
NCT04355767
COMPLETED
PHASE3
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
NCT04513158
TERMINATED
PHASE2
Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma
NCT04502472
TERMINATED
PHASE2/PHASE3
Convalescent Plasma in the Treatment of Covid-19
NCT04730401
UNKNOWN
PHASE2