Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

Official title:

Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375098
• Other study ID #: 200415015
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: September 2020
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient older than 18 years

• CALL score = 9 (progression risk score)

• PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)

• Any symptoms of COVID-19 infection

• Admission due to COVID-19 infection

• Signed informed consent

• ECOG before COVID-19 infection 0-2

Exclusion Criteria:

• PaFi <200 or mechanical ventilation indication

• Clinically relevant co-infection at admission

• Pregnancy or lactation

• IgA deficiency or IgA nephropathy

• Immunoglobulin or plasma administration in the last 60 days

• Contraindication to transfusion or previous allergy to blood-derived products

• Do-not-resuscitate status

• Patients receiving other investigational drug for COVID-19 in a clinical trial

• Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Biological:
• COVID-19 convalescent plasma
COVID-19 convalescent plasma

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad Católica	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Fundacion Arturo Lopez Perez

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization		1 year follow up
Secondary	Median duration of fever	Days	1 year
Secondary	Median duration of mechanical ventilation	Days	1 year follow up
Secondary	Median length of ICU stay	Days	1 year follow up
Secondary	Median length of admission	Days	1 year follow up
Secondary	Hospital mortality rate (percentage)		1 year follow up
Secondary	30-day mortality (percentage)		1 year follow up
Secondary	Readmission rate (percentage)		1 year follow up
Secondary	Median length of viral clearance	days	1 year follow up