NCT05595538

Brief Summary

This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. All plasma used in this protocol will be collected following the guidelines issued by the Food and Drug Administration (FDA) and the Ministry of Health in Panama. Every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. The investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event. The secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for early_phase_1 covid19

Timeline
Completed

Started Jun 2020

Shorter than P25 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

Study Start

First participant enrolled

June 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 7, 2022

Last Update Submit

October 24, 2022

Conditions

COVID-19

Keywords

Convalescent plasmacritically illSARS-CoV-2COVID-19neutralizing antibodies

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants who received at least one unit more than one day

    Transfusion of multiple doses (up to 5 doses) of 300-600 ml of convalescent plasma from COVID-19

    8 days

Secondary Outcomes (4)

  • Development of plasma transfusion reaction

    8 days

  • Overall Survival

    60 days

  • oxygen Support

    60 days

  • Clinical Status

    60 days

Study Arms (1)

Intubated COVID-19 patients admitted to the ICU.

EXPERIMENTAL

Participants intubated who consent immediately before intubation to receive more than one dose of COVID-19 convalescent plasma.

Biological: Multiple doses of anti-SARS-CoV-2 Convalescent Plasma

Interventions

Multiple doses of anti-SARS-CoV-2 Convalescent PlasmaBIOLOGICAL

SARS-CoV-2 Convalescent Plasma(1-2 units; \~300-600 mL with the presence of IgG anti-SARS-CoV-2.

Also known as: COVID-19 Convalescent Plasma
Intubated COVID-19 patients admitted to the ICU.

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 Real Time-polymerase chain reaction(PCR) testing.
  • Subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements.
  • Intubated
  • Consent to storage of specimens for future testing.

You may not qualify if:

  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
  • Severe multi-organ failure, and hemodynamic instability.
  • Other documented uncontrolled infections.
  • Severe disseminated intravascular coagulopathy (DIC) needing factor replacement, FreshFrozen Plasma, cryoprecipitate.
  • On dialysis.
  • Active intracranial bleeding.
  • Clinically significant myocardial ischemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social

Panama City, Panama

Location

MeSH Terms

Conditions

COVID-19Critical Illness

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Ricardo Aguilar, M.D

    1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social

    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

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 27, 2022

Study Start

June 6, 2020

Primary Completion

September 29, 2020

Study Completion

October 14, 2020

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)