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

Phase 1

• Conditions: CoronaVirus Disease 2019; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005410-18-PL
• Lead Sponsor: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-16
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified