NCT04333355

Brief Summary

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
terminated

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

March 31, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

March 31, 2020

Last Update Submit

February 8, 2021

Conditions

COVID-19

Keywords

COVID-19SARS-CoV-2Convalescent plasma

Outcome Measures

Primary Outcomes (1)

  • Side effects

    Identify possible adverse effects after the administration of convalescent plasma

    14 days

Secondary Outcomes (5)

  • Heart Failure

    14 days

  • Pulmonary Edema

    14 days

  • Allergic Reaction

    14 days

  • Viral load of SARS-CoV-2

    48 hrs

  • Viral load of SARS-CoV-2

    14 days

Study Arms (1)

COVID-19 patients receiving Convalescent Plasma

EXPERIMENTAL

Convalescent Plasma from patients who recently recover from COVID-19

Biological: Convalescent Plasma

Interventions

Convalescent PlasmaBIOLOGICAL

Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.

Also known as: Supportive standard care
COVID-19 patients receiving Convalescent Plasma

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years and older
  • Confirmed SARS-CoV-2 Infection by RT-PCR.
  • Serious or life-threatening infection defined as:
  • Serious:
  • Dyspnea
  • Respiratory rate greater than or equal to 30 cycles / minute.
  • Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.
  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
  • A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.
  • Life-threatening infection:
  • respiratory failure.
  • septic shock.
  • dysfunction or multiple organ failure.
  • Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.
  • Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).

You may not qualify if:

  • Patients with a history of allergic reaction to any type of previous transfusion.
  • Heart failure patients at risk of volume overload.
  • Patients with a history of chronic kidney failure in the dialysis phase.
  • Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
  • Any case where the investigator decides that the patient is not suitable for the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San José

Monterrey, Nuevo León, 64718, Mexico

Location

Related Publications (1)

  • Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.

    PMID: 32167489BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • José Fe Castilleja-Leal, MD.

    Hospital San José

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

May 8, 2020

Primary Completion

August 20, 2020

Study Completion

August 20, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

ME(1)