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

Phase 1

• Conditions: Covid19
• Interventions: Biological: Anti-SARS-CoV-2 immunoglobulin

• Registration Number: NCT04573855
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05
• Study Start: 2020-12-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-SARS-CoV-2 immunoglobulin	Anti-SARS-CoV-2 immunoglobulin	Treatment with Anti-SARS-CoV-2 immunoglobulin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Infusional reaction rate	28 days	number of patients who experienced adverse events after the immunoglobulin infusion
Evaluation of clinical status	Day 0, Day 14, Day 21 and Day 28	Results of a 7-point ordinal severity scale
Length of hospital stay	For as long as the duration of the hospital stay	number of days between admission and discharge
Orotracheal Intubation Rate	28 days	Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
Mortality rate	28 days	number of deceased patients
Modulation of serum and cellular inflammatory marker	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
Reduction of viral load evaluated by area under the curve of RT-PCR values	Day 0, Day 3, Day 7 and Day 14	Viral load reduction evaluated by area under the curve of RT-PCR values
Assessment of adverse events	28 days	Frequency of adverse events classified following CTCAE