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

Overview

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.

Full Title of Study: “TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2021

Interventions

  • Biological: Anti-SARS-CoV-2 immunoglobulin
    • Treatment with Anti-SARS-CoV-2 immunoglobulin

Arms, Groups and Cohorts

  • Experimental: Anti-SARS-CoV-2 immunoglobulin
    • Treatment with Anti-SARS-CoV-2 immunoglobulin
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • Length of hospital stay
    • Time Frame: For as long as the duration of the hospital stay
    • number of days between admission and discharge
  • 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
  • Infusional reaction rate
    • Time Frame: 28 days
    • number of patients who experienced adverse events after the immunoglobulin infusion
  • Mortality rate
    • Time Frame: 28 days
    • number of deceased patients
  • Assessment of adverse events
    • Time Frame: 28 days
    • Frequency of adverse events classified following CTCAE
  • Evaluation of clinical status
    • Time Frame: Day 0, Day 14, Day 21 and Day 28
    • Results of a 7-point ordinal severity scale
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • D’Or Institute for Research and Education
  • Provider of Information About this Clinical Study
    • Sponsor

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