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

NCT ID: NCT04834089

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 618 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-05-31

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

Detailed Description

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

.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental product group (Stage A)

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

Group Type: EXPERIMENTAL

AntiSARS-CoV-2 Serum

Intervention Type: 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.

Placebo group (Stage C)

Saline solution Administration Route: Intravenous

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline solution Administration Route: Intravenous

Experimental product group (Stage B)

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

Group Type: EXPERIMENTAL

AntiSARS-CoV-2 Serum

Intervention Type: 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 C)

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

Group Type: EXPERIMENTAL

AntiSARS-CoV-2 Serum

Intervention Type: 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.

Interventions

AntiSARS-CoV-2 Serum

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.

Intervention Type: BIOLOGICAL

Placebo

Saline solution Administration Route: Intravenous

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults 18 years of age or older;

2. Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5 days ago;

3. Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as:

1. Presenting sudden onset of anosmia and/or ageusia without any other reasonable explanation and/or;

2. Thoracic image by radiography, tomography or ultrasonography compatible with acute clinical symptoms findings of COVID-19 and/or;

3. Acute onset of cough accompanied by fever and/or

4. 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.

4. Oxygen saturation by pulse oximetry ≥92%

5. Agree to periodic contacts by phone, electronic means and home visits;

6. 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:

7. 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:

8. 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).

Exclusion Criteria

1. Presenting COVID-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in WHO COVID-19 progression scale;

2. 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;

3. Any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history;

4. Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study;

5. To have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion;

6. 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;

7. 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:

8. 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:

9. Previous immunization with vaccine against COVID-19

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Butantan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Palacios, MD, PhD

Role: STUDY_DIRECTOR

Butantan Institute

Locations

Hospital do Rim

São Paulo, São Paulo, Brazil

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

São Paulo, , Brazil

Countries

Brazil

Central Contacts

Ricardo Palacios, MD, PhD

Role: CONTACT

ricardo.palacios@butantan.gov.br

+551137232121

Facility Contacts

Jose Osmar Medina Pestana, MD,PhD

Role: primary

Other Identifiers

SAS-01-IB

Identifier Type: -

Identifier Source: org_study_id