Clinical study to assess the safety and tolerability of administration, directly into a vein, of human umbilical cord and placental blood plasma (Plasmacord®) in patients with Severe acute respiratory syndrome resulting from Sars-Cov-2 infection (fever, cough headache, muscle aches and difficulty breathing)

Clinical study to evaluate the safety and tolerability of intravenous infusion of plasma from human umbilical cord and placental blood (Plasmacord®) in patients with Severe Acute Respiratory Syndrome resulting from Sars-Cov-2 infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-4pfygr

Enrollment

Unknown

Registered

2020-08-13

Start date

2020-07-27

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus infection, unspecified

Interventions

Single group: 10 adult participants, of both genders with a positive test for COVID-19, with indication of transfer to the intensive care unit (ICU) by the responsible medical team, according to the c

Biological/vaccine

VS2.002.001.010.001

Eligibility

Inclusion criteria

Inclusion criteria: Age over 18 years; both sexes; positive test for COVID-19; indication for transfer to the intensive care unit (ICU) by the responsible medical team; according to institutional criteria and protocols; absence of therapeutic alternative

Exclusion criteria

Exclusion criteria: Pregnant women; under 18 years old; no indication of transfer to the intensive care unit (ICU) by the responsible medical team; according to institutional criteria and protocols; existence of therapeutic alternative

Design outcomes

Primary

Measure	Time frame
Infusion and allergic reactions;Secondary infection;Life-threatening adverse events;Significant reduction in the number of days in the ICU;Significant reduction in the ICU readmission rate;Significant reduction in the need for mechanical ventilation (frequency and duration);Significant reduction in the total hospital stay;Improved respiratory rate;Significant reduction in FiO2 required to achieve PaO2> 93%;Significant reduction in the need for installation of vasoactive drugs (dose and duration);Significant reduction in the total lethality rate;Significant improvement in the oxygen saturation rate;Significant reduction in systemic severity and prognosis scores (SOFA and APACHEII)	—

Measure

Time frame

Infusion and allergic reactions;Secondary infection;Life-threatening adverse events;Significant reduction in the number of days in the ICU;Significant reduction in the ICU readmission rate;Significant reduction in the need for mechanical ventilation (frequency and duration);Significant reduction in the total hospital stay;Improved respiratory rate;Significant reduction in FiO2 required to achieve PaO2> 93%;Significant reduction in the need for installation of vasoactive drugs (dose and duration);Significant reduction in the total lethality rate;Significant improvement in the oxygen saturation rate;Significant reduction in systemic severity and prognosis scores (SOFA and APACHEII)

—

Secondary

Measure	Time frame
Reduction in plasma C-reactive protein rate;Improvement in laboratory indicators of systemic activity: Hemoglobin; TGO / TGP, Troponin I, Urea / creatinine, lactate;Fever cessation;Significant reduction of ground glass area on tomography;Significant reduction in the rate of C-reactive protein;Increased arteriovenous O2 difference;Improved acid-base balance	—

Countries

Brazil

Contacts

Public ContactElie Fiss

Hospital Alemão Oswaldo Cruz

eliefiss@uol.com.br55 11 3549-1542

Outcome results

None listed

Source: REBEC (via WHO ICTRP)