Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2020-005410-18-PL
EUCTR2020-005410-18-PL
Active, not recruiting
Phase 1

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

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zaklad Opieki Zdrowotnej0 sites480 target enrollmentNovember 16, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCoronaVirus Disease 2019Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
CoronaVirus Disease 2019
Sponsor
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Enrollment
480
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 16, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Study on the treatment of the mild congnitive impairment due to Alzheimer's disease with Zinc Sulphate
EUCTR2019-000604-15-ITIVERSITÀ DEGLI STUDI G. D'ANNUNZIO CHIETI-PESCARA215
Recruiting
Phase 1
Study to evaluate the efficacy and safety of low-dose aspirin as an add-on to standard therapy in patients with bipolar disorder (ASPIRIN BD)Bipolar Affective DisorderMedDRA version: 21.1Level: LLTClassification code: 10004908Term: Bipolar affective disorder Class: 10037175Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
CTIS2024-516584-86-00Instytut Psychiatrii I Neurologii100
Active, not recruiting
Not Applicable
Multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of two different treatment regimens of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic tendinopathies of the upper and lower limbs
EUCTR2012-005030-11-ITIBSA INSTITUT BIOCHIMIQUE SA
Active, not recruiting
Phase 1
Multicentre, double-blind, randomized, placebo-controlled, parallel-group, clinical trial to evaluates the clinical efficacy and safety of immunotherapy with purified major allergen Alt a 1 in patients with allergic rhinoconjunctivitis with or without mild to moderate asthma, sensitized the fungus Alternaria alternata
EUCTR2010-024440-15-ESDIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
Active, not recruiting
Not Applicable
Multicentre, randomised, double-blind, placebo-controlled clinical study to assess the efficacy and safety of UroVaxom in chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS) - Uro-Vaxom in patients with chronic prostatitis and chronic pelvic pain syndromeChronic prostatitis and chronic pelvic pain syndromeMedDRA version: 9.1Level: LLTClassification code 10009109Term: Chronic prostatitisMedDRA version: 9.1Level: LLTClassification code 10064189Term: Chronic pelvic pain syndrome
EUCTR2007-004609-85-PTOM PHARMA200