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

NCT05135546 | Terminated Phase 2 DMC

• 1 other identifier: FORRIF
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of patients discharged from the hospital with clinical status according to the WHO Ordinal Scale For Clinical Improvement - 3 points or less

  The efficacy is evaluated in terms of the number of patients discharged from the hospital with clinical status according to the WHO Ordinal Scale For Clinical Improvement - 3 points or less

  28 days post randomization

Secondary Outcomes (6)

• Number of patients discharged from the hospital with clinical status according to the WHO Ordinal Scale For Clinical Improvement - 3 points or less

  14 days post randomization

• Hospital length of stay

  28 days post randomization

• Number of ICU-free days

  28 days post randomization

• Number of ventilation-free days

  28 days post randomization

• Number of oxygen support-free days

  28 days post randomization

Study Arms (2)

Experimental

EXPERIMENTAL

Recombinant nonimmunogenic staphylokinase lyophilisate for preparation of a solution for inhaled administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, regardless of body weight.

Drug: Recombinant nonimmunogenic staphylokinase

Placebo control

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Recombinant nonimmunogenic staphylokinase DRUG

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

Experimental

Placebo DRUG

6 ml of 0.9% solution of NaCl for inhalation

Also known as: Saline solution

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Supergene, LLC: lead
• Russian Academy of Medical Sciences: collaborator

Study Sites (2)

City Clinical Hospital No.52

Moscow, 123182, Russia

Location

N.V. Sklifosovsky Research Institute of Emergency Medicine

Moscow, 129090, Russia

Location

Related Publications (1)

• Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.

  PMID: 34418399 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sergey S. Markin, MD, PhD

  LLC "SuperGene"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and study investigators will be blinded to subject treatment
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At clinical centers, patients will be randomly distributed by the "envelope method" into two groups to receive Fortelyzin® or placebo. The drugs will be administered after the signed informed consent. Fortelyzin® will be administered by inhalation of a dose of 15 mg.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 26, 2021
• Study Start: December 27, 2021
• Primary Completion: February 1, 2023
• Study Completion: May 31, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)