NCT04412486

Brief Summary

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for early_phase_1 covid19

Timeline
Completed

Started Jun 2020

Longer than P75 for early_phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

May 28, 2020

Last Update Submit

November 28, 2023

Conditions

COVID-19

Keywords

COVID-19 Convalescent PlasmaCoronavirusSARS-CoV-2

Outcome Measures

Primary Outcomes (5)

  • Change in PaO2/FiO2 after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.

    3 Days

  • Change in pulse oximetry status after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.

    3 Days

  • Change in aO2 after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.

    3 Days

  • Change in respiratory rate after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.

    3 Days

  • Change in intubation status after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.

    3 Days

Secondary Outcomes (6)

  • Change in Sequential Organ Failure Assessment (SOFA).

    Days 1, 3, 7, and 28

  • Change in 8-point ordinal clinical deterioration scale.

    Days 1, 3, 7, and 28

  • Length of ICU/hospital stay.

    Days 1, 3, 7, and 28

  • Development of plasma transfusion reactions.

    Days 1, 3, 7, and 28

  • Development of immune complex disorders.

    Days 1, 3, 7, and 28

  • +1 more secondary outcomes

Study Arms (1)

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

EXPERIMENTAL

Transfusion of COVID-19 convalescent plasma to participants with serious or life threatening complications from COVID-19 or are at high risk to develop serious complications.

Biological: COVID Convalescent Plasma

Interventions

COVID Convalescent PlasmaBIOLOGICAL

One unit of COVID Convalescent Plasma transfused on Day 0

Also known as: CCP, COVID-19 Convalescent Plasma
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
  • Laboratory confirmed diagnosis of SARS-CoV-2 infection
  • Hypoxia (PaO2/FiO2 \<300, Pulse oximetry \<93% at rest
  • Evidence of pulmonary infiltration
  • Respiratory failure
  • Sepsis
  • Multiple organ dysfunction or failure (assessed by SOFA score)
  • Informed consent provided by the patient or legally authorized representative (LAR)

You may not qualify if:

  • Greater than 21 days from confirmed COVID-19 diagnosis
  • Receipt of pooled immunoglobulin transfusion in previous 28 days
  • History of prior reaction to transfused blood products
  • Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (8)

  • Syal K. COVID-19: Herd immunity and convalescent plasma transfer therapy. J Med Virol. 2020 Sep;92(9):1380-1382. doi: 10.1002/jmv.25870. Epub 2020 Jul 11. No abstract available.

    PMID: 32281679BACKGROUND

  • Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.

    PMID: 32066525BACKGROUND

  • 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.

    PMID: 16940336BACKGROUND

  • Wong SS, Yuen KY. The management of coronavirus infections with particular reference to SARS. J Antimicrob Chemother. 2008 Sep;62(3):437-41. doi: 10.1093/jac/dkn243. Epub 2008 Jun 18.

    PMID: 18565970BACKGROUND

  • Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. doi: 10.1093/jac/dkw338. Epub 2016 Sep 1.

    PMID: 27585965BACKGROUND

  • 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: 26735992BACKGROUND

  • Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.

    PMID: 32283152BACKGROUND

  • Jiang S, Hillyer C, Du L. Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses. Trends Immunol. 2020 May;41(5):355-359. doi: 10.1016/j.it.2020.03.007. Epub 2020 Apr 2.

    PMID: 32249063BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Gailen D Marshall, Jr., MD, PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Chair for Research, Department of Medicine; Director, Division of Allergy, Asthma and Clinical Immunology

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

June 1, 2020

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)