Back to resultsTREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Anti-SARS-CoV-2 immunoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Inpatients diagnosed with COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 10 days;
- Age ≥ 18 years and <75 years
- No indication of invasive ventilatory support at the time of randomization;
- Signature of the Informed Consent Form.
Exclusion Criteria:
- Pregnant or lactating women
- Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
- Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
- History of anaphylaxis or severe allergic reaction;
- Previous use of any heterologous serum;
- Participation in trials of prophylactic drugs or vaccines for COVID-19;
- Administration of immunoglobulins and / or any blood products in the previous three months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anti-SARS-CoV-2 immunoglobulin
Control
Arm Description
Treatment with Anti-SARS-CoV-2 immunoglobulin
Outcomes
Primary Outcome Measures
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Clearence of viral RNA evaluated by RT-PCR
Secondary Outcome Measures
Reduction of viral load evaluated by area under the curve of RT-PCR values
Viral load reduction evaluated by area under the curve of RT-PCR values
Length of hospital stay
number of days between admission and discharge
Orotracheal Intubation Rate
Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
Infusional reaction rate
number of patients who experienced adverse events after the immunoglobulin infusion
Mortality rate
number of deceased patients
Assessment of adverse events
Frequency of adverse events classified following CTCAE
Evaluation of clinical status
Results of a 7-point ordinal severity scale
Modulation of serum and cellular inflammatory marker
Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels
Full Information
NCT ID
NCT04573855
First Posted
September 30, 2020
Last Updated
September 30, 2020
Sponsor
D'Or Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT04573855
Brief Title
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
Official Title
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-SARS-CoV-2 immunoglobulin
Arm Type
Experimental
Arm Description
Treatment with Anti-SARS-CoV-2 immunoglobulin
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Anti-SARS-CoV-2 immunoglobulin
Intervention Description
Treatment with Anti-SARS-CoV-2 immunoglobulin
Primary Outcome Measure Information:
Title
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Time Frame
28 days
Title
Clearence of viral RNA evaluated by RT-PCR
Time Frame
72 h
Secondary Outcome Measure Information:
Title
Reduction of viral load evaluated by area under the curve of RT-PCR values
Description
Viral load reduction evaluated by area under the curve of RT-PCR values
Time Frame
Day 0, Day 3, Day 7 and Day 14
Title
Length of hospital stay
Description
number of days between admission and discharge
Time Frame
For as long as the duration of the hospital stay
Title
Orotracheal Intubation Rate
Description
Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
Time Frame
28 days
Title
Infusional reaction rate
Description
number of patients who experienced adverse events after the immunoglobulin infusion
Time Frame
28 days
Title
Mortality rate
Description
number of deceased patients
Time Frame
28 days
Title
Assessment of adverse events
Description
Frequency of adverse events classified following CTCAE
Time Frame
28 days
Title
Evaluation of clinical status
Description
Results of a 7-point ordinal severity scale
Time Frame
Day 0, Day 14, Day 21 and Day 28
Title
Modulation of serum and cellular inflammatory marker
Description
Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels
Time Frame
Day 0, Day 3 and Day 7.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients diagnosed with COVID-19 by RT-PCR;
Time between symptom onset and inclusion ≤ 10 days;
Age ≥ 18 years and <75 years
No indication of invasive ventilatory support at the time of randomization;
Signature of the Informed Consent Form.
Exclusion Criteria:
Pregnant or lactating women
Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
History of anaphylaxis or severe allergic reaction;
Previous use of any heterologous serum;
Participation in trials of prophylactic drugs or vaccines for COVID-19;
Administration of immunoglobulins and / or any blood products in the previous three months.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
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