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TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19

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ClinicalTrials.gov Identifier: NCT04573855
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
D'Or Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Anti-SARS-CoV-2 immunoglobulin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anti-SARS-CoV-2 immunoglobulin
Treatment with Anti-SARS-CoV-2 immunoglobulin
Biological: Anti-SARS-CoV-2 immunoglobulin
Treatment with Anti-SARS-CoV-2 immunoglobulin

No Intervention: Control



Primary Outcome Measures :
  1. Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0. [ Time Frame: 28 days ]
  2. Clearence of viral RNA evaluated by RT-PCR [ Time Frame: 72 h ]

Secondary Outcome Measures :
  1. 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

  2. Length of hospital stay [ Time Frame: For as long as the duration of the hospital stay ]
    number of days between admission and discharge

  3. 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

  4. Infusional reaction rate [ Time Frame: 28 days ]
    number of patients who experienced adverse events after the immunoglobulin infusion

  5. Mortality rate [ Time Frame: 28 days ]
    number of deceased patients

  6. Assessment of adverse events [ Time Frame: 28 days ]
    Frequency of adverse events classified following CTCAE

  7. Evaluation of clinical status [ Time Frame: Day 0, Day 14, Day 21 and Day 28 ]
    Results of a 7-point ordinal severity scale

  8. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04573855    
Other Study ID Numbers: PCL04/2020
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs