COVID-19 Convalescent Plasma Therapy

Phase 2

Completed

• Conditions: SARS-CoV-2 Infection; COVID-19 Infection
• Interventions: Biological: Convalescent plasma

• Registration Number: NCT04747158
• Lead Sponsor: Universidad Nacional de Asunción

Brief Summary

This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 \[COVID-19\] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-10
• Primary Completion: 2020-12-10
• Study Completion: 2021-01-10
• Study First Submitted: 2021-01-27
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 18 Years and older
• Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
• Patients with no more than 15 days from the onset of symptoms
• Signed informed consent

Exclusion Criteria

• Severely ill patients admitted directly to the ICU.
• Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
• History of previous hypersensitivity to plasma transfusions.
• History of immunoglobulin A (IgA) deficiency
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent plasma	Convalescent plasma	COVID-19 convalescent plasma

Primary Outcome Measures

Name	Time	Method
Overall survival (30-day mortality)	30 days	To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.

Secondary Outcome Measures

Name	Time	Method
Median length of hospital stay	30 days	To describe the median length of hospital stay in days
Change in clinical status	0, 3, 7 and 14 days	To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.
Change in inflammatory marker: ferritin	0, 7 and 14 days	To measure changes in ferritin (μg/L) at 0, 7 and 14 days
Change in inflammatory marker: D dimer	0, 7 and 14 days	To measure changes in D dimer (mg/L) at 0, 7 and 14 days
Change in inflammatory marker: leukocytes	0, 7 and 14 days	To measure leukocytes (/mm3) changes at 0, 7 and 14 days
Serum Antibody Titers	0, 3 and 7 days	To measure immunoglobulin G (IgG) SARS-CoV 2 titles
Transfer to ICU	30 days	To asses the frequency of patients admitted to ICU
Transfusion related events	4 hours	To asses the frequency of adverse events to convalescent plasma

Trial Locations

Locations (1)

Facultad de Ciencias Médicas - Universidad Nacional de Asunción; 🇵🇾 Asunción, Paraguay