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

Covid19 Clinical Trial

Official title:

TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04573855
• Other study ID #: PCL04/2020
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2020
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.		28 days
Primary	Clearence of viral RNA evaluated by RT-PCR		72 h
Secondary	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
Secondary	Length of hospital stay	number of days between admission and discharge	For as long as the duration of the hospital stay
Secondary	Orotracheal Intubation Rate	Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization	28 days
Secondary	Infusional reaction rate	number of patients who experienced adverse events after the immunoglobulin infusion	28 days
Secondary	Mortality rate	number of deceased patients	28 days
Secondary	Assessment of adverse events	Frequency of adverse events classified following CTCAE	28 days
Secondary	Evaluation of clinical status	Results of a 7-point ordinal severity scale	Day 0, Day 14, Day 21 and Day 28
Secondary	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.