Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support

COVID-19 Clinical Trial

Official title:

Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528368
• Other study ID #: 34651120.8.0000.5249
• Status: Recruiting
• Phase: Phase 2
• Start date: December 11, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2021
• Source: D'Or Institute for Research and Education
• Contact: Eduardo M Rego, MD, PhD
• Phone: 55 16 981110090
• Email: edumrego[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Recipient Inclusion Criteria:

• Confirmed diagnosis of COVID-19 by RT-PCR;
• Time between symptom onset and inclusion = 7 days;
• Chest tomography with <50% involvement of the lung parenchyma;
• No indication of ventilatory support at the time of randomization;
• Sign the consent form.

Recipient Exclusion Criteria:

• Contraindication to transfusion or history of previous reactions to blood products for transfusion;
• Pregnant women;
• Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.

Donor Inclusion Criteria for Plasmapheresis:

• Convalescent plasma donation will be eligible for patients = 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
• SARS-COV-2 negative RT-PCR;
• Asymptomatic for at least 14 days;
• SARS-CoV-2 anti-peak titre with dilution = 1: 320;
• Sign the consent form.

Donor Exclusion Criteria:

• Female gender with previous pregnancy;
• Absence of peripheral venous network compatible with the apheresis procedure;
• Positive or indeterminate result in any of the infectious screening tests;
• Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Biological:
• Convalescent plasma
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution = 1: 320.

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.	To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.	0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Assessment of clinical improvement using an Ordinal Severity Scale	The seven-point scale is as follows: Death 7 points; Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points; Hospital admission for mechanical ventilation = 5 points; Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points; Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points; Hospital admission but not requiring oxygen therapy = 2 points; Discharged with limitations of activities = 1 point; Discharged with no limitations of activities = 0 point;	0, 7, 10, 14, 21 and 28 days
Secondary	Evaluate oxygen saturation		0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Evaluate oxygen supplementation		0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Assess respiratory rate		0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)		0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Length of hospital stay		21 days
Secondary	Length of stay in intensive care		21 days
Secondary	Assess the rate of orotracheal intubation		21 days
Secondary	Change in the profile of cytokines/chemokines in both groups	Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)	0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration		0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary	Death rate		7, 10, 14, 21 and 28 days
Secondary	Rate of transfusion reactions to convalescent plasma infusion		21 days