NCT04411602

Brief Summary

Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

December 19, 2025

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

May 22, 2020

Last Update Submit

December 15, 2025

Conditions

Severe Acute Respiratory SyndromeCOVID

Keywords

Corona VirusConvalescent plasma

Outcome Measures

Primary Outcomes (1)

  • Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure.

    Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma

    Track patient progress for 28 days post initial convalescent dose.

Secondary Outcomes (2)

  • Ventilatory free days

    Track patient progress for 28 days post initial convalescent dose.

  • Patient mortality (including death from any cause)

    Track patient progress for 28 days post initial convalescent dose.

Study Arms (1)

Treatment with Convalescent Plasma

EXPERIMENTAL

SARS-CoV-2 convalescent plasma from approved donors will be transfused into severely ill patients with confirmed COVID-19 severe respiratory distress. Plasma will be administered on days 0, 2,4, 6 and 8.

Drug: SARS-CoV-2 plasma

Interventions

SARS-CoV-2 plasmaDRUG

To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.

Also known as: Convalescent plasma
Treatment with Convalescent Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laboratory confirmed COVID-19
  • Severe or Immediately life threatening COVID-19
  • Dyspnea
  • Respiratory frequency \> 30/minute
  • Blood oxygen saturation \<93%
  • Life-threatening disease is defined as the following
  • Respiratory Failure.
  • Septic shock, and/or,
  • Multiple organ dysfunction or failure.

You may not qualify if:

  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
  • Other documented uncontrolled infection.
  • Severe DIC needing factor replacement, FFP, cryoprecipitate.
  • On dialysis.
  • Active intracranial bleeding.
  • Clinically significant myocardial ischemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ascension Providence Hospital, Novi Campus

Novi, Michigan, 48374, United States

Location

Ascension Providence Hospital, Southfield Campus

Southfield, Michigan, 48075, United States

Location

Ascension Macomb-Oakland Hospital, Warren Campus

Warren, Michigan, 48093, United States

Location

Related Publications (14)

  • Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.

    PMID: 7578724BACKGROUND

  • Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.

    PMID: 15372080BACKGROUND

  • 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: 16121363BACKGROUND

  • Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.

    PMID: 27867062BACKGROUND

  • Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.

    PMID: 12967670BACKGROUND

  • Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.

    PMID: 7985997BACKGROUND

  • 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: 15616839BACKGROUND

  • Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23.

    PMID: 16183666BACKGROUND

  • 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: 29923831BACKGROUND

  • Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.

    PMID: 27532807BACKGROUND

  • van Erp EA, Luytjes W, Ferwerda G, van Kasteren PB. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019 Mar 22;10:548. doi: 10.3389/fimmu.2019.00548. eCollection 2019.

    PMID: 30967872BACKGROUND

  • Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.

    PMID: 31826992BACKGROUND

  • 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: 25030060BACKGROUND

  • Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910.

    PMID: 11564809BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Shukri David, MD

    Ascension Providence Hospital, Southfield Campus

    PRINCIPAL INVESTIGATOR

  • Debra J Levan, DO

    Ascension Macomb-Oakland Hospital, Warren Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Severely ill patients with COVID-19 severe respiratory distress
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 2, 2020

Study Start

April 7, 2020

Primary Completion

April 7, 2021

Study Completion

April 7, 2021

Last Updated

December 19, 2025

Record last verified: 2021-07

Locations

US(3)