Multicentre, randomized, double-blind, placebo-controlled, non-commercial clinical trial to evaluate the efficacy and safety of specific anti-SARS-CoV-2 immunoglobulin in the treatment of COVID-19

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005410-18-PL

Enrollment

480

Registered

2020-11-16

Start date

2020-12-02

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CoronaVirus Disease 2019

Interventions

Product Name: anti SARS-CoV-2 immunoglobulin Pharmaceutical Form: Solution for injection Current Sponsor code: Anti-SARS-CoV-2 immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years 2. Sign informed consent in order to participate in the study 3. SARS-CoV-2 infection (positive RT-PCR test for SARS-CoV-2) 4. Indication for hospitalization due to the course of COVID-19 5. The patient's clinical condition is assessed at 3-5 on the ORDINAL scale: • 3 - Hospitalization without oxygen therapy • 4 - Hospitalization with low flow oxygen support on a nasal mask or mustache • 5 - hospitalization with high flow oxygen therapy> 15l / min without mechanical ventilation 6. There are no contraindications to the use of standard symptomatic treatment in accordance with the guidelines of PTEiLChZ. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 336 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144

Exclusion criteria

Exclusion criteria: The patient's inability to comply with the protocol in opinion of the Investigator 1. Intake of any experimental anti-COVID-19 study drugs 2. Intake of any plasma therapy, in particular plasma therapy with COVID-19 convalescents 3. Infection with human immunodeficiency virus (HIV) 4. Pregnancy or breastfeeding 5.All conditions that the doctor qualifying for the study considers harmful to the patient participating in this study, including any clinically significant deviations from normal clinical laboratory values ??or concurrent medical events or situations that prevent the proper performance of the study (e.g. insufficient knowledge of the Polish language by the patient in the opinion of the researcher) 6. Participation in another interventional clinical trial in the last 30 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of specific anti-SARS-CoV-2 immunoglobulin used in a hospital conditions (administered in the form of intramuscular injection) along with standard symptomatic treatment in accordance with the guidelines of PTEiLChZ in patients with SARS-CoV-2 infection. No need for supplementation with oxygen on day 7 and 14.;Secondary Objective: Safety-related endpoints: 1. Occurrence of serious adverse events up to day 28 from the start of study therapy Effectiveness-related endpoints: 1. The need for mechanical ventilation in the patient 2. Time of using oxygen therapy 3. The need to use tocilizumab or other anti-cytokine drugs 4. Time to discharge from hospital 5. Time to negative PCR test for SARS-CoV-2 virus RNA 6. Occurrence of any COVID-19 related symptoms on day 28 ;Primary end point(s): Primary endpoint: No oxygen supplementation required on Day 7 and 14 from the start of the therapy. Secondary endpoints: Safety-related endpoints: 1. Occurrence of serious adverse events up to day 28 from the start of study therapy Effectiveness-related endpoints: 1. The need for mechanical ventilation in the patient 2. Time of using oxygen therapy 3. The need to use tocilizumab or other anti-cytokine drugs 4. Time to discharge from hospital 5. Time to negative PCR test for SARS-CoV-2 virus RNA 6. Occurrence of any COVID-19 related symptoms on day 28 Exploratory endpoints 1. Changes in inflammatory parameters and coagulation parameters at successive time points 2. Presence of lung tissue pathology after completion of therapy 3. Generation of a specific humoral response: Presence and titer of anti-SARS-CoV-2 antibodies during the therapy and after the observation period (on day 28 from the start of study therapy);Timepoint(s) of evaluation of this end point: 1. Change of inflammatory parameters and parameters of the coagulation system at successive time points 2. Presence of lung tissue pathology after completion of therapy 3. Generat	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of specific anti-SARS-CoV-2 immunoglobulin used in a hospital conditions (administered in the form of intramuscular injection) along with standard symptomatic treatment in accordance with the guidelines of PTEiLChZ in patients with SARS-CoV-2 infection. No need for supplementation with oxygen on day 7 and 14.;Secondary Objective: Safety-related endpoints: 1. Occurrence of serious adverse events up to day 28 from the start of study therapy Effectiveness-related endpoints: 1. The need for mechanical ventilation in the patient 2. Time of using oxygen therapy 3. The need to use tocilizumab or other anti-cytokine drugs 4. Time to discharge from hospital 5. Time to negative PCR test for SARS-CoV-2 virus RNA 6. Occurrence of any COVID-19 related symptoms on day 28 ;Primary end point(s): Primary endpoint: No oxygen supplementation required on Day 7 and 14 from the start of the therapy. Secondary endpoints: Safety-related endpoints: 1. Occurrence of serious adverse events up to day 28 from the start of study therapy Effectiveness-related endpoints: 1. The need for mechanical ventilation in the patient 2. Time of using oxygen therapy 3. The need to use tocilizumab or other anti-cytokine drugs 4. Time to discharge from hospital 5. Time to negative PCR test for SARS-CoV-2 virus RNA 6. Occurrence of any COVID-19 related symptoms on day 28 Exploratory endpoints 1. Changes in inflammatory parameters and coagulation parameters at successive time points 2. Presence of lung tissue pathology after completion of therapy 3. Generation of a specific humoral response: Presence and titer of anti-SARS-CoV-2 antibodies during the therapy and after the observation period (on day 28 from the start of study therapy);Timepoint(s) of evaluation of this end point: 1. Change of inflammatory parameters and parameters of the coagulation system at successive time points 2. Presence of lung tissue pathology after completion of therapy 3. Generat

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/D	—

Countries

Poland

Contacts

Public ContactKrzysztof Tomasiewicz

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zaklad Opieki Zdrowotnej

krzysztoftomasiewicz@umlub.pl00488153 49 414564

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026