NCT04573855UnknownPhase 1
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
D'Or Institute for Research and Education0 sites41 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 41
- Primary Endpoint
- Clearence of viral RNA evaluated by RT-PCR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
No Intervention
Anti-SARS-CoV-2 immunoglobulin
Experimental
Treatment with Anti-SARS-CoV-2 immunoglobulin
Intervention: Anti-SARS-CoV-2 immunoglobulin (Biological)
Outcomes
Primary Outcomes
Clearence of viral RNA evaluated by RT-PCR
Time Frame: 72 h
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Time Frame: 28 days
Secondary Outcomes
- Infusional reaction rate(28 days)
- Evaluation of clinical status(Day 0, Day 14, Day 21 and Day 28)
- Length of hospital stay(For as long as the duration of the hospital stay)
- Orotracheal Intubation Rate(28 days)
- Mortality rate(28 days)
- Modulation of serum and cellular inflammatory marker(Day 0, Day 3 and Day 7.)
- Reduction of viral load evaluated by area under the curve of RT-PCR values(Day 0, Day 3, Day 7 and Day 14)
- Assessment of adverse events(28 days)
Investigators
Similar Trials
Completed
Phase 1
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy AdultsCOVID-19NCT04661839Emergent BioSolutions28
Completed
Phase 2
Convalescent Plasma for Treatment of COVID-19 Patients With PneumoniaCorona Virus InfectionSARS-CoV 2SARS PneumoniaPneumoniaNCT04374565University of Virginia29
Completed
Phase 1
Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19COVID-19NCT04514302Hospital San Jose Tec de Monterrey32
Unknown
Phase 1
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19 Omicron) mRNA Vaccine (Phase 1)COVID-19NCT05433194Suzhou Abogen Biosciences Co., Ltd.48
Completed
Phase 1
Safety and Immunogenicity of EXG-5003COVID-19NCT04863131Fujita Health University40