Phase I/II Randomized Clinical Trial to evaluate the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 hyperimmune serum. The study will include patients at early stage of COVID-19 with increased risk for severe disease due to underlying medical conditions to determine the utility of an equine heterologous serum anti-SARS-CoV-2 to avoid progression to a severe COVID-19
Phase I/II Clinical Trial, randomized, multicentric, on three stages (A, B and C) to evaluate the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 serum and dose escalation. The study will be in three stages: Stage A: 30 kidney transplanted participants (very high risk), where 15 will received 1 vial (5 mL) and 15 will received 2 vials (10 mL) of serum; Stage B: 30 immunocompetent participants with at least 2 risk factors for severe disease (high risk) who will receive the dose selected by stage A; Stage C: 558 participants, of very high risk and high risk, compared with placebo in allocation 2:1 (endpoint-driven design) Allocation type Open study without allocation of randomization on Stages A and B Randomized allocation with placebo comparator in Stage C. Recruitment Status: On planning Date of 1st recruitment Expected: April 2021 Target sample siz 618 (30/30/538) participants .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
618
Stage A: 30 kidney transplanted participants (very high risk), where 15 will received 1 vial (5 mL) and 15 will received 2 vials (10 mL) of serum; Stage B: 30 immunocompetent participants with at least 2 risk factors for severe disease (high risk) who will receive the dose selected by stage A; Stage C: 558 participants, of very high risk and high risk, compared with placebo in allocation 2:1.
Saline solution Administration Route: Intravenous
Hospital do Rim
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Frequency of local and systemic adverse events
Frequency of local and systemic adverse events, solicited and unsolicited, during the infusion and within 12 hours after administration of the heterologous serum
Time frame: 12 hours after product administration
Anti-SARS-CoV-2 serum average life
Anti-SARS-CoV-2 serum average life measured by equine antibodies levels
Time frame: 28 days after product administration
Proportion of patients with change in COVID-19 disease progression profile after administration of anti-SARS-CoV-2 serum
Proportion of patients with change in COVID-19 disease progression profile after administration of anti-SARS-CoV-2 serum, based on the WHO clinical progression scale (not progression to severe disease requiring mechanical ventilation or death - Score 7 or larger)
Time frame: 14 days after product administration
Frequency of local and systemic adverse events
Frequency of local and systemic adverse events, solicited and unsolicited, up to 28 days of serum heterologous administration
Time frame: 28 days after product administration
Frequency of severe adverse events
Frequency of severe adverse events and of the special interest up to 28 days after administration of serum heterologous
Time frame: 28 days after product administration
Clinical response
Clinical response according serum anti-SARS-CoV-2 dosage
Time frame: 14 days after product administration
Symptoms duration
Symptoms duration associated to COVID-19
Time frame: 28 days after product administration
Hospitalization time in Intensive Care Unit
Hospitalization time in Intensive Care Unit related to COVID-19
Time frame: 28 days after product administration
Deaths
Frequency of deaths by COVID-19
Time frame: 28 days after product administration
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