Correlated Drug Terms (2)

---

	Name (Synonyms)	Correlation
drug2231	Serologic testing Wiki	1.00
drug2377	Support treatment Wiki	1.00

Correlated MeSH Terms (1)

---

	Name (Synonyms)	Correlation
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

---

	Name (Synonyms)	Correlation

Primary Outcomes

Description: To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital

Measure: Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment

Time: Over a period of 28 days

---

Secondary Outcomes

Description: Number of Participants with resolution of fever (<38ºC temperature)

Measure: Clinical evolution

Time: Over a period of 28 days

---

Description: The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death

Measure: Clinical evolution by seven-parameter ordinal scale

Time: 3, 7, 14 and 28 days

---

Description: Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness

Measure: Multi-organ failure progression

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment

Measure: Change in hemoglobin concentration

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment

Measure: Change in blood cell count

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment

Measure: Change in serum creatinine level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment

Measure: Change in aspartate aminotransferase level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment

Measure: Change in alanin aminotransferase level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment

Measure: Change in bilirubin level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment

Measure: Change in lactate dehydrogenase level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment

Measure: Change in creatine kinase level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment

Measure: Change in creatine kinase MB level

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L

Measure: Change in C reactive protein concentration

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment

Measure: Change in D Dimer concentration

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment

Measure: Change in Procalcitonin concentration

Time: 3, 7, 14 and 28 days

---

Description: Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment

Measure: Change in IL6 level

Time: 3, 7, 14 and 28 days

---

Description: Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)

Measure: Radiography imaging

Time: Over a period of 60 days

---

Description: Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)

Measure: Tomography imaging

Time: Over a period of 60 days

---

Description: Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio

Measure: Assessment of oxygenation

Time: 3, 7, 14 and 28 days

---

Description: Viral Load Quantification

Measure: Viral Load

Time: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first

---

Description: Neutralizing antibody anti SARS-CoV-2 titer evolution

Measure: Antibody titer

Time: Day 0, Day 3 and Day 7

---

Description: Number of days without use of Oxygen

Measure: Oxygen-free days through Day 60

Time: Until hospital discharge or a maximum of 60 days whichever comes first

---

Description: Number of days without use of mechanical ventilation

Measure: Mechanical ventilation-free days through Day 28

Time: Until hospital discharge or a maximum of 28 days whichever comes first

---

Description: Time outside of ICU, in days

Measure: Intensive Care Unit (ICU)-free days through Day 28

Time: Until hospital discharge or a maximum of 28 days whichever comes first

---

Description: Time outside of the hospital, in days

Measure: Hospital-free days through Day 60

Time: Until hospital discharge or a maximum of 60 days whichever comes first

---

Other Outcomes

Description: Occurrence of adverse events during inactivated convalescent plasma transfusion, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0

Measure: Incidence of adverse events

Time: Up to 28 days

---