Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19

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.

Conditions

• COVID-19

Interventions

BIOLOGICAL

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

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

Sponsors & Collaborators

• Complejo Hospitalario Dr. Arnulfo Arias Madrid

  collaborator OTHER

• Hospital Santo Tomas

  collaborator OTHER

• Hospital Punta Pacífica, Pacífica Salud

  collaborator UNKNOWN

• Insituto Conmemorativo Gorgas de Estudios para la Salud

  collaborator UNKNOWN

• Sociedad Panameña de Hematología

  collaborator UNKNOWN

• Institute of Scientific Research and High Technology Services (INDICASAT AIP)

  collaborator UNKNOWN

• University of Panama

  collaborator UNKNOWN

• Sistema Nacional de Investigación de Panamá

  collaborator UNKNOWN

• Hospital Regional Dr. Rafael Estévez

  lead OTHER

Principal Investigators

• Ricardo Aguilar, M.D · 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-06

Primary Completion

2020-09-29

Completion

2020-10-14

Countries

• Panama

Study Locations