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Anti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous

Saline solution Administration Route: Intravenous

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.

AntiSARS-CoV-2 Serum

Placebo

Ricardo Palacios, MD, PhD

Jose Osmar Medina Pestana, MD,PhD

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

.

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.

Stage C of this study was designed as double-blind to avoid the bias introduction in the efficacy and adverse events evaluation. The clinical care team, the responsible professional for administering the serum and the participant will not know which product under investigation will be administered. Only the pharmacists or nurses responsible for the randomization of the study, separation and blinding of the product under investigation will have access to unblinded information. The allocation of the product under investigation will only be revealed after the completion of the participants' following up and database closing to guarantee a long-term safety evaluation of the product. The sponsor's operational team will also remain blind.

If necessary, independent scientists not involved with the clinical or laboratory evaluation of the participants, who analyze the unblinded data of laboratory results.

Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases

Phase I/II Clinical Trial for Dose Escalation and Safety Assessment and Clinical Response of Anti-SARS-CoV-2 Serum Produced by Instituto Butantan

Frequency and magnitude of equine antibodies titers 14 and 28 days after administration of anti-SARS-CoV-2 serum

Frequency and magnitude of neutralizing antibodies titers Against SARS-CoV-2 after administration of anti-SARS-CoV-2 serum

Proportion of medical assistance related to COVID-19 (score ≥ 3 of WHO)

Proportion of emergency service visit related to COVID-19

Proportion of hospitalization related to COVID-19 (defined as ≥24 hours of hospital care) (score ≥ 4 of WHO)

Proportion of patients with change in COVID-19 disease progression profile after administration of anti-SARS-CoV-2 serum according to underlying medical conditions.

Frequency of local and systemic adverse events, solicited and unsolicited, during the infusion and within 12 hours after administration of the heterologous serum

Anti-SARS-CoV-2 serum average life measured by equine antibodies levels

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)

Frequency of local and systemic adverse events, solicited and unsolicited, up to 28 days of serum heterologous administration

Frequency of severe adverse events and of the special interest up to 28 days after administration of serum heterologous

Clinical response according serum anti-SARS-CoV-2 dosage

Hospitalization time in Intensive Care Unit related to COVID-19

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases	NCT04834089	Immunosuppressi... Cancer COVID-19 Other Complicat... Chemotherapy Renal Disease Diabetes Mellit... Cardiovascular ... Chronic Obstruc...	AntiSARS-CoV-2 ... Placebo	18 Years -	Butantan Institute
Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases	NCT04834089	Immunosuppressi... Cancer COVID-19 Other Complicat... Chemotherapy Renal Disease Diabetes Mellit... Cardiovascular ... Chronic Obstruc...	AntiSARS-CoV-2 ... Placebo	18 Years -	Butantan Institute

Spots Global Cancer Trial Database for other complication of kidney transplant