Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Objective: to evaluate the tolerability, safety and efficacy of inhaled usage of the Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) vs placebo in patients with COVID-19.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supergene, LLC
• Collaborator: Russian Academy of Medical Sciences

Criteria

Inclusion Criteria:

• Men and women aged 18 and over

• Clinical status according to the WHO scale - 6, 7, 8 and 9 points.

• Verified respiratory infection COVID-19 by real-time PCR (quantitative)

• Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:

• women who have a negative pregnancy test and use the following contraceptives:

intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);

• men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility)

• Availability of signed and dated informed consent of the patient to participate in the study.

Exclusion Criteria:

• Clinical status according to the WHO scale - 1, 2, 3, 4 and 5 points.

• Increased risk of bleeding:

• extensive bleeding at the present time;

• intracranial (including subarachnoid) hemorrhage at the present time.

• Lactation, pregnancy

• Known hypersensitivity to Fortelyzin®.