COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04374032

Jasna Dzananovic, Mpharm

Jasna.Dzananovic@Bosnalijek.com

2020-05-05

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - patients with laboratory-confirmed (pcr) covid-19 infection - patients with moderate to severe covid-19 infection - hospitalized patients on clinical centers and cantonal hospitals - patients with radiology-confirmed pneumonia within the clinical condition of covid-19 infection including pulmonary opacity - patients with a clinical indication for pneumonia: increased body temperature (defined as a value above ≥ 36.6⁰c axillary route, ≥ 37.2°c oral route or ≥ 37.8 °c rectal route), and/or dyspnea, and/or cough, and/or spo2 <96% - patients aged above 18, both genders - patients able and willing to understand the study, adhere to all study procedures and sign a written informed consent form (icf) prior to entering the study or with the assistance of the witness

- patients not covid-19 positive - patients with mild covid-19 infection - patients who are study subjects in another clinical study for another investigational agent for covid-19 - patients with malignant hypertension - patients with malignant disease and who are treated for malignant diseases in the last 5 years - patients with severe liver and kidney insufficiency - patients who are receiving therapy with an immunomodulatory or immunosuppressive agent - patients aged below 18, female patients who are pregnant or breastfeeding - known allergy to study drug or any component thereof - use of haloperidol, dopamine antagonists, or nonsteroidal anti-inflammatory drugs, except paracetamol.

2

Bosnalijek D.D

18

None

Bosnia and Herzegovina

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE;Time to onset of change in the patient's clinical condition

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2247, "treatment_name": "Metenkefalin+tridecactide", "treatment_type": "Other targeted therapies+anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]