Patients with COVID -19 disease
Conditions
Interventions
Trade Name: NORMOSANG
Product Name: Normosang
Pharmaceutical Form: Concentrate for concentrate for solution for infusion
Sponsors
Thomayerova nemocnice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women or men aged 18 to 65 years; • Laboratory-proven COVID-19 disease (SARS-CoV-2 proven PCR) from upper airway swabs • Diseases with moderate clinical manifestations requiring hospitalization (eg fever, SpO2 = 93% presence of respiratory symptoms - eg cough, dyspnea and / or X-ray infiltrate findings), as assessed by the treating physician; • Women of childbearing potential who may become pregnant must have a negative urine or blood pregnancy test at the initial visit and use an acceptable method of contraception for the duration of the study; (Acceptable methods of contraception include: barrier spermicide, oral, transdermal, injectable or implantable contraception, intrauterine device, abstinence, and surgical sterilization of the partner) Women who cannot become pregnant: after hysterectomy, bilateral oophorectomy, bilateral tubal ligation, are after menopause for at least 12 months or with proven infertility for any reason; • The patient's ability to cooperate and sign the informed consent form 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Need for pulmonary ventilation at study entry; • Known hypersensitivity to the active substance; • Pregnancy and breast-feeding; • Value of Fe2 +, ferritin, Hb, HCT (all above ULN); • Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illnesses in whom participation in a clinical trial could pose an additional risk at the discretion of the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to verify safety and the potential of a registered drug in the fight against a highly contagious pandemic disease;Secondary Objective: - monitoring the frequency of worsening of patients into severe disease with the need for supportive lung ventilation; -monitoring of time to normalization of immunological parameters; -monitoring of time to normalization of body temperature, CRP, leukocyte count; -monitoring of the hospital lenght; - monitoring the rate of virus elimination from HCD secretions; -monitoring of the occurrence of adverse events;Primary end point(s): confirmation of safety of the drug ;Timepoint(s) of evaluation of this end point: within 28 days after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - evaluation of the change in symptom score -- influence on selected laboratory parameters during the development of COVID-19 disease - monitoring the frequency of deterioration of patients into severe disease with the need for supportive lung ventilation; - monitoring the time to normalization of immunological parameters - monitoring of time to normalization of body temperature, CRP, leukocyte count, - monitoring of hospitalization time; - monitoring the rate of virus elimination from HCD secretions; - monitoring for adverse events.;Timepoint(s) of evaluation of this end point: weekly, till Day 28 | — |
Countries
Czech Republic
Contacts
Public ContactSkopek -trial coordinator
Thomayerova nemocnice
Outcome results
None listed