TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
1 other identifier
interventional
41
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Dec 2020
Shorter than P25 for phase_1 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedOctober 5, 2020
September 1, 2020
3 months
September 30, 2020
September 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
28 days
Clearence of viral RNA evaluated by RT-PCR
72 h
Secondary Outcomes (8)
Reduction of viral load evaluated by area under the curve of RT-PCR values
Day 0, Day 3, Day 7 and Day 14
Length of hospital stay
For as long as the duration of the hospital stay
Orotracheal Intubation Rate
28 days
Infusional reaction rate
28 days
Mortality rate
28 days
- +3 more secondary outcomes
Study Arms (2)
Anti-SARS-CoV-2 immunoglobulin
EXPERIMENTALTreatment with Anti-SARS-CoV-2 immunoglobulin
Control
NO INTERVENTIONInterventions
Treatment with Anti-SARS-CoV-2 immunoglobulin
Eligibility Criteria
You may qualify if:
- Inpatients diagnosed with COVID-19 by RT-PCR;
- Age ≥ 18 years and \<75 years
- No indication of invasive ventilatory support at the time of randomization;
- Signature of the Informed Consent Form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 5, 2020
Study Start
December 1, 2020
Primary Completion
February 28, 2021
Study Completion
March 31, 2021
Last Updated
October 5, 2020
Record last verified: 2020-09