COVID-19
Conditions
Keywords
Convalescent plasma, SARS-CoV-2
Brief 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.
Interventions
BIOLOGICALConvalescent plasma
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.
Sponsors
Hospital do Coracao
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs. | 0, 3, 6, 9, 12, 15, 18 and 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate oxygen saturation | 0, 3, 6, 9, 12, 15, 18 and 21 days | — |
| Evaluate oxygen supplementation | 0, 3, 6, 9, 12, 15, 18 and 21 days | — |
| Assess respiratory rate | 0, 3, 6, 9, 12, 15, 18 and 21 days | — |
| Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms) | 0, 3, 6, 9, 12, 15, 18 and 21 days | — |
| Length of hospital stay | 21 days | — |
| Assessment of clinical improvement using an Ordinal Severity Scale | 0, 7, 10, 14, 21 and 28 days | 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; |
| Assess the rate of orotracheal intubation | 21 days | — |
| Change in the profile of cytokines/chemokines in both groups | 0, 3, 6, 9, 12, 15, 18 and 21 days | 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) |
| Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration | 0, 3, 6, 9, 12, 15, 18 and 21 days | — |
| Death rate | 7, 10, 14, 21 and 28 days | — |
| Rate of transfusion reactions to convalescent plasma infusion | 21 days | — |
| Length of stay in intensive care | 21 days | — |
Countries
Brazil
Contacts
Primary ContactEduardo M Rego, MD, PhD
Backup ContactAbel Costa Neto, MD
Outcome results
None listed