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

NCT ID: NCT04573855

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-03-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-SARS-CoV-2 immunoglobulin

Treatment with Anti-SARS-CoV-2 immunoglobulin

Group Type: EXPERIMENTAL

Anti-SARS-CoV-2 immunoglobulin

Intervention Type: BIOLOGICAL

Treatment with Anti-SARS-CoV-2 immunoglobulin

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anti-SARS-CoV-2 immunoglobulin

Treatment with Anti-SARS-CoV-2 immunoglobulin

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

D'Or Institute for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PCL04/2020

Identifier Type: -

Identifier Source: org_study_id