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

NCT04834089 | Unknown Phase 1 DMC

• 1 other identifier: SAS-01-IB
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Immunosuppression; Cancer; COVID-19; Other Complication of Kidney Transplant; Chemotherapy; Renal Disease; Diabetes Mellitus; Cardiovascular Diseases; Chronic Obstructive Pulmonary Disease

Keywords

Anti-SARS-CoV-2 serum; safety; pharmacokinetic; efficacy

Outcome Measures

Primary Outcomes (3)

• 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

  12 hours after product administration

• Anti-SARS-CoV-2 serum average life

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

  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)

  14 days after product administration

Secondary Outcomes (6)

• Frequency of local and systemic adverse events

  28 days after product administration

• Frequency of severe adverse events

  28 days after product administration

• Clinical response

  14 days after product administration

• Symptoms duration

  28 days after product administration

• Hospitalization time in Intensive Care Unit

  28 days after product administration

Other Outcomes (6)

• Frequency and magnitude of equine antibodies titers

  28 days after product administration

• Frequency and magnitude of neutralizing antibodies titers Against SARS-CoV-2

  28 days after product administration

• Proportion of medical assistance

  14 days after product administration

Study Arms (4)

Experimental product group (Stage A)

EXPERIMENTAL

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

Biological: AntiSARS-CoV-2 Serum

Placebo group (Stage C)

PLACEBO COMPARATOR

Saline solution Administration Route: Intravenous

Other: Placebo

Experimental product group (Stage B)

EXPERIMENTAL

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

Biological: AntiSARS-CoV-2 Serum

Experimental product group (Stage C)

EXPERIMENTAL

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

Biological: AntiSARS-CoV-2 Serum

Interventions

AntiSARS-CoV-2 Serum BIOLOGICAL

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.

Experimental product group (Stage A); Experimental product group (Stage B); Experimental product group (Stage C)

Placebo OTHER

Saline solution Administration Route: Intravenous

Placebo group (Stage C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older;
• Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5 days ago;
• Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as:
• Presenting sudden onset of anosmia and/or ageusia without any other reasonable explanation and/or;
• Thoracic image by radiography, tomography or ultrasonography compatible with acute clinical symptoms findings of COVID-19 and/or;
• Acute onset of cough accompanied by fever and/or
• Acute onset of three or more of the following symptoms: fever, cough, fatigue or general weakness, headache, myalgia, sore throat, runny nose, dyspnea, anorexia or nausea or vomit, diarrhea and mental status change.
• Oxygen saturation by pulse oximetry ≥92%
• Agree to periodic contacts by phone, electronic means and home visits;
• Demonstrate intention to participate in the study, documented by Informed Consent Form signature on the part of the participant.
• For the very high risk group:
• Being on continuous drug immunosuppressant more than two weeks due to a basic medical condition (e.g. transplant or cancer);
• For the high risk group:
• To present at least two risk factors for developing serious COVID-19 (Over 60 years of age; diabetes mellitus; chronic obstructive pulmonary disease; kidney disease; cardiovascular diseases and body mass index ≥ 35).

You may not qualify if:

• Behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements;
• Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study;
• The participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. Dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as Researcher staff or staff from the location conducting the study;
• Any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol.
• For female:
• Pregnancy (confirmed by positive β-hCG test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration;
• For stages A and B:
• Previous immunization with vaccine against COVID-19

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (2)

Hospital do Rim

São Paulo, São Paulo, 04038-002, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Neoplasms; COVID-19; Kidney Diseases; Diabetes Mellitus; Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Palacios, MD, PhD

  Butantan Institute

  STUDY DIRECTOR

Central Study Contacts

Ricardo Palacios, MD, PhD

CONTACT

+551137232121; ricardo.palacios@butantan.gov.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

BR (2)