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

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: Covid19
• Intervention / Treatment: Biological: Anti-SARS-CoV-2 immunoglobulin

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 2; Phase 1

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

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.	28 days
Clearence of viral RNA evaluated by RT-PCR	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	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	number of days between admission and discharge	For as long as the duration of the hospital stay
Orotracheal Intubation Rate	Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization	28 days
Infusional reaction rate	number of patients who experienced adverse events after the immunoglobulin infusion	28 days
Mortality rate	number of deceased patients	28 days
Assessment of adverse events	Frequency of adverse events classified following CTCAE	28 days
Evaluation of clinical status	Results of a 7-point ordinal severity scale	Day 0, Day 14, Day 21 and Day 28
Modulation of serum and cellular inflammatory marker	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

• Sponsor: D'Or Institute for Research and Education

Study record dates

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