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

NCT05135546 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Recombinant nonimmunogenic staphylokinase

15 mg of drug reconstituted in 6 ml of 0.9% solution of NaCl for inhalation Other Name: Fortelyzin®

DRUG

Placebo

6 ml of 0.9% solution of NaCl for inhalation

Sponsors & Collaborators

  • Russian Academy of Medical Sciences

    collaborator OTHER

  • Supergene, LLC

    lead INDUSTRY

Principal Investigators

  • Sergey S. Markin, MD, PhD · LLC "SuperGene"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2023-02-01
Completion
2023-05-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135546 on ClinicalTrials.gov