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| Name | Class |
|---|---|
| Hospital do Coracao | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma + Standard treatment | Experimental | Participants will receive the standard treatment and convalescent plasma |
|
| Standard treatment | No Intervention | Participants will receive the standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma | Biological | The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical improvement using an Ordinal Severity Scale | The seven-point scale is as follows:
|
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Recipient Inclusion Criteria:
Recipient Exclusion Criteria:
Donor Inclusion Criteria for Plasmapheresis:
Donor Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo M Rego, MD, PhD | Contact | 55 16 981110090 | edumrego@hotmail.com | |
| Abel Costa Neto, MD | Contact | 55 11 964999091 | abel.neto@oncologiador.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo M Rego, MD, PhD | D'Or Institute for Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D'Or Institute for Research and Education | Recruiting | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 0, 7, 10, 14, 21 and 28 days |
| 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 |
| Length of stay in intensive care | 21 days |
| Assess the rate of orotracheal intubation | 21 days |
| 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 |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |