COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005410-18/PL

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zakład Opieki Zdrowotnej - Krzysztof Tomasiewicz

krzysztoftomasiewicz@umlub.pl

2020-11-16

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

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

18

100

Poland

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

480

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) Punkty końcowe związane z bezpieczeństwem: 1. Występowanie poważnych działań niepożądanych w okresie do 28 dnia od rozpoczęcia terapii badanej Punkty końcowe związane ze skutecznością: 1. Konieczność zastosowania u pacjenta wentylacji mechanicznej 2. Czas stosowania tlenoterapii 3. Konieczność stosowania tocilizumabu lub innych leków przeciwcytokinowych 4. Czas do wypisania ze szpitala 5. Czas do uzyskania negatywnego wyniku badania PCR w kierunku RNA wirusa SARS-CoV-2 6. Występowanie jakichkolwiek objawów związanych z COVID-19 w dniu 28

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2/Phase 3

[{"arm_notes": null, "treatment_id": 88, "treatment_name": "Anti-covid-19 human immunoglobulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]