- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573855
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
September 30, 2020 updated by: D'Or Institute for Research and Education
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
41
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Anti-SARS-CoV-2 immunoglobulin
Treatment with Anti-SARS-CoV-2 immunoglobulin
|
Treatment with Anti-SARS-CoV-2 immunoglobulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Time Frame: 28 days
|
28 days
|
Clearence of viral RNA evaluated by RT-PCR
Time Frame: 72 h
|
72 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of viral load evaluated by area under the curve of RT-PCR values
Time Frame: Day 0, Day 3, Day 7 and Day 14
|
Viral load reduction evaluated by area under the curve of RT-PCR values
|
Day 0, Day 3, Day 7 and Day 14
|
Length of hospital stay
Time Frame: For as long as the duration of the hospital stay
|
number of days between admission and discharge
|
For as long as the duration of the hospital stay
|
Orotracheal Intubation Rate
Time Frame: 28 days
|
Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
|
28 days
|
Infusional reaction rate
Time Frame: 28 days
|
number of patients who experienced adverse events after the immunoglobulin infusion
|
28 days
|
Mortality rate
Time Frame: 28 days
|
number of deceased patients
|
28 days
|
Assessment of adverse events
Time Frame: 28 days
|
Frequency of adverse events classified following CTCAE
|
28 days
|
Evaluation of clinical status
Time Frame: Day 0, Day 14, Day 21 and Day 28
|
Results of a 7-point ordinal severity scale
|
Day 0, Day 14, Day 21 and Day 28
|
Modulation of serum and cellular inflammatory marker
Time Frame: Day 0, Day 3 and Day 7.
|
Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels
|
Day 0, Day 3 and Day 7.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
February 28, 2021
Study Completion (Anticipated)
March 31, 2021
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
Other Study ID Numbers
- PCL04/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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