NCT04343261

Brief Summary

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

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

April 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2020

Completed
1 month until next milestone

Results Posted

Study results publicly available

September 17, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

April 8, 2020

Results QC Date

September 1, 2020

Last Update Submit

September 22, 2020

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)COVIDCoronavirus

Keywords

SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Mortality within 28 days

    Up to 28 days

  • Viral Load

    Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).

    Day 0, Day 3, Day 5, and Day 7

  • Serum Antibody Titers

    Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)

    Day 0, Day 3, Day 5, and Day 7

Study Arms (1)

COVID-19 patients treated with convalescent plasma

EXPERIMENTAL

Severely ill COVID-19 patients treated with convalescent plasma

Biological: Convalescent Plasma

Interventions

Convalescent PlasmaBIOLOGICAL

treatment with 2 Units of convalescent plasma

COVID-19 patients treated with convalescent plasma

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All genders
  • Age \> 18 yrs and \< 90 yrs
  • Must have laboratory confirmed COVID-19
  • Must provide informed consent
  • Must have severe or immediately life-threatening COVID-19,
  • Severe disease is defined as:
  • dyspnea,
  • respiratory frequency ≥ 30/min,
  • blood oxygen saturation ≤ 93%,
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
  • lung infiltrates \> 50% within 24 to 48 hours
  • Life-threatening disease is defined as:
  • respiratory failure,
  • septic shock
  • multiple organ dysfunction or failure

You may not qualify if:

  • Age \< 18 yrs and \> 90 yrs
  • COVID-19 negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinity Health Of New England

Hartford, Connecticut, 06105, United States

Location

Related Publications (6)

  • Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25.

    PMID: 32883593RESULT

  • Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20.

    PMID: 32951151RESULT

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PMID: 37162745DERIVED

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PMID: 36734509DERIVED

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PMID: 34013969DERIVED

  • Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

    PMID: 33044747DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Results Point of Contact

Title
Latha Dulipsingh, MD
Organization
Saint Francis Hospital and Medical Center
Latha.Dulipsingh@trinityhealthofne.org
860-714-4402

Study Officials

  • Latha Dulipsingh, MD

    Saint Francis Hospital and Medical Centerr/Trinity Health Of New England

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 13, 2020

Study Start

April 10, 2020

Primary Completion

July 23, 2020

Study Completion

August 13, 2020

Last Updated

September 24, 2020

Results First Posted

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)