COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04459325

Eugene V. Zuev, MD

evzuev@generium.ru

2020-07-07

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: written informed consent for participation in the study men and women aged ≥18 years laboratory-confirmed diagnosis of coronavirus infection caused by covid19, moderate severity * *criteria for moderate flow (just one point) mandatory criterion pneumonia additional criteria (used to characterize the disease and are not required to determine the severity) fever above 38 ° c respiratory rate more than 22 / min shortness of breath during physical exertion spo2 <95% с-reactive protein (crp) of serum more than 10 mg / l patients with pneumonia with a stable level of hemoglobin saturation by oxygen (> 93%) on oxygen support and / or receiving respiratory support of non-invasive mechanical ventilation

individual intolerance or hypersensitivity to the active or any of the excipients of the drug tigerase® the need for invasive mechanical ventilation at the time of inclusion of the patient patients severe condition (one of the following characteristics): respiratory distress syndrome with respiratory rate ≥30 per minute saturation of hemoglobin with oxygen ≤93% with oxygen support patient participate in any clinical trials and / or taking the experimental drug within 30 days before inclusion this trial severe competitive respiratory system diseases (bronchial asthma, chronic obstructive pulmonary disease - copd, cystic fibrosis, interstitial lung disease) positive results of laboratory testing for hiv and hepatitis b and c life expectancy less than 12 months without covid-19 other diseases and conditions, significant laboratory or instrumental deviation, which, according to investigator opinion, may impact the results of the study, limit the patient's participation in the trial or create an unreasonable risk for the patient patient's unwillingness or disability to comply with the recommendations prescribed by protocol, as well as any concomitant medical or serious mental conditions that render the patient unsuitable for participation in the study, limit the legitimacy of obtaining informed consent or may affect the patient's ability to participate in the study (including disability to use a nebulizer) positive pregnancy test in women the period of breastfeeding in women refusal of male patients and female patients with preserved reproductive function to use adequate methods of contraception throughout the study and for at least 30 days after the end of therapy with the studied drug

2

AO GENERIUM

18

100

Russia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

The proportion of patients with mechanical ventilation;Category change on WHO Ordinal Scale for Clinical Improvement

None

Phase 3

[{"arm_notes": "", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]