Pilot, open-label, monocentric study evaluating safety and clinical effect of application of NORMOSANG® in patients with COVID-19 disease

Phase 1

Active, not recruiting

• Conditions: Patients with COVID -19 disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004682-39-CZ
• Lead Sponsor: Thomayerova nemocnice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-13
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified