COVID-19Phase 3PLASCOSSANCT04372979

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

A Phase 3 study testing Transfusion of SARS-CoV-2 Convalescent Plasma. and Transfusion of standard Plasma. in people with COVID-19, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: COVID-19
What is being tested?: Transfusion of SARS-CoV-2 Convalescent Plasma. and Transfusion of standard Plasma.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 4 sitesFrance
Study dates: 14 Sep 2020to 1 Jun 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 22Show fewer

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
Major sickle cell syndrome
BMI > 30 kg/m2
OR one of the biological criteria :
D-dimer 1 µg/mL,
Lymphocytes < 0.8 G/L,
Ferritin > 300 µg/L,
Troponin I > 11 pg/mL or Troponin T > 24.8 pg/mL

Who cannot join

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,

Show all 14Show fewer

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

Trial locations and contacts

4 sites in 1 country.

France4 sites

HIA Percy
Clamart, 92140
HIA Laveran
Marseille, 13013
HIA Bégin
Saint-Mandé, 94160
HIA Sainte Anne
Toulon, 83000

Other trials in France

About this study

Official title: Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.

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.

Read the detailed description

During SARS-CoV-2 infection, two clinical-biological phases can be observed: an initial viral phase followed by an immunological phase whose onset has been associated with more severe prognosis. Hospitalized patients with comorbidities or clinical risk factors have a higher risk of respiratory functions deterioration and significant risk to need intensive care.

Early transfusion of convalescent plasma (2 units of 200-230 mL of apheresis plasma inactivated by amotosalen) would prevent this secondary worsening and reduce the risk to be transferred to intensive care, length of stay and mortality. Considering clinical and biological manifestations of the disease, including coagulation disorders, endothelial alterations, immunological disorders, it seems interesting to compare this convalescent plasma with a SARS-CoV-2 lacking antibodies plasma.

Conditions: COVID-19
Being tested: Transfusion of SARS-CoV-2 Convalescent Plasma., Transfusion of standard Plasma.
Keywords: SARS-CoV-2, COVID 19, Convalescent plasma
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transfusion of SARS-CoV-2 Convalescent Plasma.Drug
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
Transfusion of standard Plasma.Drug
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.

Study groups in NCT04372979
Study group	Role	What they receive
SARS-CoV-2 patients treated with convalescent plasma	Experimental	Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma. Receives: 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. Receives: Drug: Transfusion of standard Plasma.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 30

Secondary outcomes (12)

Morbidity
The percentage of patients i) not hospitalized, without limitation of activities, ii) Not hospitalized, with activity limitation, iii) Hospitalized without oxygen therapy, iv) Hospitalized with oxygen therapy, v) Hospitalized with intensive oxygen therapy or non- invasive ventilation (NIV), vi) Hospitalized and intubated or on extracorporeal membrane oxygenation (ECMO), vii) Dead.
Measured: Day 15
Morbidity
Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.
Measured: Day 30
Mortality
Measured: Day 30
Length of stay
Measured: Day 30
Effect on viral pharyngeal specimen clearance
Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.
Measured: At inclusion and Day 7
Effect on viral blood specimen clearance
Quantitative SARS-CoV2 PCR carried out on blood specimen.
Measured: At inclusion and Day 7
Effect on hemostasis disorders
Effects on biological hemostasis parameters disorders.
Measured: At inclusion, Day 1 and every 48 hours
Kinetics of appearance of neutralizing antibodies
Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.
Measured: At inclusion, Day 7
Transfusion endotheliopathy effect
Evolution of biological endotheliopathy parameters
Measured: At inclusion, Day 1, Day 7
Transfusion biological Inflammation effect
Evaluation of biological dosages on inflammation effects
Measured: At inclusion, Day 1, Day 7
Transfusion hemovigilance
Number of transfusion adverse events
Measured: 30 days
Decrease in the consumption of antibiotics
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20201 Jun 2021

First posted4 May 2020
Study start14 Sep 2020
Primary completion1 Jun 2021
Study completion1 Jun 2021

Why it stopped: Reluctance of patients and physicians in this transfusion study setting. Blood products have expired. New variants have appeared since the plasma collection period. Some recent publications question the effectiveness of transfusion.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (47)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04372979
Sponsor's protocol ID: 2020-A01166-33
Acronym: PLASCOSSA
Status last verified: Apr 2022
First submitted: 24 Apr 2020
Last updated: 14 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31986264
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.
PubMed 32031570
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.
PubMed 32238757
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.
PubMed 32219428
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.
PubMed 32243945
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.
PubMed 32155444
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.
PubMed 16121363
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.
PubMed 15016880
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.
PubMed 29923831
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.
PubMed 32198501
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.
PubMed 32284614
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.
PubMed 32103284
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.
PubMed 32213337
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.
PubMed 30830861
Tirado SM, Yoon KJ. Antibody-dependent enhancement of virus infection and disease. Viral Immunol. 2003;16(1):69-86. doi: 10.1089/088282403763635465.
PubMed 12725690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.
ClinicalTrials.gov ID: NCT04372979
Acronym / sponsor ID: PLASCOSSA / 2020-A01166-33
Conditions: COVID-19
Keywords: SARS-CoV-2, COVID 19, Convalescent plasma
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Reluctance of patients and physicians in this transfusion study setting. Blood products have expired. New variants have appeared since the plasma collection period. Some recent publications question the effectiveness of transfusion.
Enrolment: 18 participants (actual)
Lead sponsor: Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
Collaborators: University Hospital, Grenoble
Study start: 14 Sep 2020 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 4 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SARS-CoV-2 patients treated with convalescent plasma	Experimental	Drug: Transfusion of SARS-CoV-2 Convalescent Plasma.Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.
SARS-CoV-2 patients treated with standard plasma	Active comparator	Drug: Transfusion of standard Plasma.Subjects will receive an intravenous injection of standard Plasma.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Age 18-90 years ;
COVID-19 confirmed case ;
Cases showing respiratory symptoms, checking at least one of the following criteria:
Risk of deterioration, checking at least one of the following comorbidity criteria :
D-dimer 1 µg/mL,

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transfusion of SARS-CoV-2 Convalescent Plasma.2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.	Drug	SARS-CoV-2 patients treated with convalescent plasma
Transfusion of standard Plasma.2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.	Drug	SARS-CoV-2 patients treated with standard plasma

Primary outcome

Survival time without needs of a ventilator.
Time frame: Day 30
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.

12 secondary outcomes

Morbidity
Time frame: Day 15
Morbidity
Time frame: Day 30
Mortality
Time frame: Day 30
Length of stay
Time frame: Day 30
Effect on viral pharyngeal specimen clearance
Time frame: At inclusion and Day 7
Effect on viral blood specimen clearance
Time frame: At inclusion and Day 7
Effect on hemostasis disorders
Time frame: At inclusion, Day 1 and every 48 hours
Kinetics of appearance of neutralizing antibodies
Time frame: At inclusion, Day 7
Transfusion endotheliopathy effect
Time frame: At inclusion, Day 1, Day 7
Transfusion biological Inflammation effect
Time frame: At inclusion, Day 1, Day 7
Transfusion hemovigilance
Time frame: 30 days
Decrease in the consumption of antibiotics
Time frame: 30 days

Results and safety

The study was stopped early (reason given: Reluctance of patients and physicians in this transfusion study setting. Blood products have expired. New variants have appeared since the plasma collection period. Some recent publications question the effectiveness of transfusion.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Background: PubMed 31986264Huang 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.
Background: PubMed 32031570Wang 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.
Background: PubMed 32238757Ahn 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.
Background: PubMed 32219428Shen 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.
Background: PubMed 32243945Zhang 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.
Background: PubMed 32155444Walls 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.
Background: PubMed 16121363Zhang 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.
Background: PubMed 15016880Subbarao 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.
Background: PubMed 29923831Ko 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.
Background: PubMed 32198501Guo 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.
Background: PubMed 32284614Thevarajan 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.
Background: PubMed 32103284Bouadma 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.
Anticoagulant treatment for the prevention of thrombotic risk in a patient hospitalized with COVID-19 and monitoring of hemostasis.Link provided by the sponsor.
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.govLink provided by the sponsor.
Transfusion of therapeutic plasma: products, indications (Haute Autorité de Santé, France)Link provided by the sponsor.
Coronavirus SARS-CoV-2 management of people at risk of severe forms (Haut Conseil de la Santé Publique; 2020)Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nathalie KOULMANN study director

Direction Centrale du Service de Santé des Armées (DCSSA)

Catherine VERRET study director

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

Christophe MARTINAUD principal investigator

Centre de Transfusion Sanguine des Armées

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival time without needs of a ventilator. (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04372979, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.