ImmunosuppressionPhase 1/2SOROCOVNCT04834089
Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases
A Phase 1/2 study testing AntiSARS-CoV-2 Serum in people with Immunosuppression and Cancer, run by Butantan Institute at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression, Cancer, COVID-19
- What is being tested?
- AntiSARS-CoV-2 Serum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 618 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2021to May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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;
- 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;
- 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;
- Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study;
- 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;
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital do Rim
São Paulo, São Paulo, 04038-002
Jose Osmar Medina Pestana, MD,PhD
Jose Osmar Medina Pestana, MD,PhD
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
About this study
Official title: Phase I/II Clinical Trial for Dose Escalation and Safety Assessment and Clinical Response of Anti-SARS-CoV-2 Serum Produced by Instituto Butantan
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
Read the 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
- Being tested
- AntiSARS-CoV-2 Serum, Placebo
- Keywords
- Anti-SARS-CoV-2 serum, safety, pharmacokinetic, efficacy
- Medical subject headings
- Neoplasms, COVID-19, Kidney Diseases, Diabetes Mellitus, Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiSARS-CoV-2 SerumBiological
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.
PlaceboOther
Saline solution Administration Route: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Experimental product group (Stage A) | Experimental | Anti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous Receives: Biological: AntiSARS-CoV-2 Serum |
| Placebo group (Stage C) | Placebo comparator | Saline solution Administration Route: Intravenous Receives: Other: Placebo |
| Experimental product group (Stage B) | Experimental | Anti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous Receives: 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 Receives: Biological: AntiSARS-CoV-2 Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours after product administration
Anti-SARS-CoV-2 serum average life
Anti-SARS-CoV-2 serum average life measured by equine antibodies levels
Measured: 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)
Measured: 14 days after product administration
Secondary outcomes (6)
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
Measured: 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
Measured: 28 days after product administration
Clinical response
Clinical response according serum anti-SARS-CoV-2 dosage
Measured: 14 days after product administration
Symptoms duration
Symptoms duration associated to COVID-19
Measured: 28 days after product administration
Hospitalization time in Intensive Care Unit
Hospitalization time in Intensive Care Unit related to COVID-19
Measured: 28 days after product administration
Deaths
Frequency of deaths by COVID-19
Measured: 28 days after product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ricardo Palacios, MD, PhD, Study director, Butantan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834089
- Sponsor's protocol ID
- SAS-01-IB
- Acronym
- SOROCOV
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial for Dose Escalation and Safety Assessment and Clinical Response of Anti-SARS-CoV-2 Serum Produced by Instituto Butantan
- ClinicalTrials.gov ID
- NCT04834089
- Acronym / sponsor ID
- SOROCOV / SAS-01-IB
- Conditions
- Immunosuppression, Cancer, COVID-19, Other Complication of Kidney Transplant, Chemotherapy, Renal Disease
- Keywords
- Anti-SARS-CoV-2 serum, safety, pharmacokinetic, efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental product group (Stage A) | Experimental | Biological: AntiSARS-CoV-2 SerumAnti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous |
| Placebo group (Stage C) | Placebo comparator | Other: PlaceboSaline solution Administration Route: Intravenous |
| Experimental product group (Stage B) | Experimental | Biological: AntiSARS-CoV-2 SerumAnti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous |
| Experimental product group (Stage C) | Experimental | Biological: AntiSARS-CoV-2 SerumAnti-SARS-CoV-2 Serum Dose: 5 mL/dose or 10 mL/dose Administration Route: Intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Oxygen saturation by pulse oximetry ≥92%
- Agree to periodic contacts by phone, electronic means and home visits;
Key exclusion criteria (11 listed)
- 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;
- 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;
- 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;
- Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiSARS-CoV-2 SerumStage 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. | Biological | Experimental product group (Stage A), Experimental product group (Stage B), Experimental product group (Stage C) |
| PlaceboSaline solution Administration Route: Intravenous | Other | Placebo group (Stage C) |
Primary outcome
Frequency of local and systemic adverse events
Time frame: 12 hours after product administration
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
Time frame: 28 days after product administration
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
Time frame: 14 days after product administration
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)
6 secondary outcomes
Frequency of local and systemic adverse events
Time frame: 28 days after product administration
Frequency of severe adverse events
Time frame: 28 days after product administration
Clinical response
Time frame: 14 days after product administration
Symptoms duration
Time frame: 28 days after product administration
Hospitalization time in Intensive Care Unit
Time frame: 28 days after product administration
Deaths
Time frame: 28 days after product administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Palacios, MD, PhD study director
Butantan Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AntiSARS-CoV-2 Serum in people with Immunosuppression and Cancer, run by Butantan Institute at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Palacios, MD, PhD (+551137232121, ricardo.palacios@butantan.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of local and systemic adverse events (time frame: 12 hours after product administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.