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COVID-19Phase 2/3FORRIFNCT05135546

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

A Phase 2/3 study testing Recombinant nonimmunogenic staphylokinase in people with COVID-19, run by Supergene, LLC at 2 sites in Russia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Recombinant nonimmunogenic staphylokinase
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
2 sitesRussia
Study dates
27 Dec 2021to 31 May 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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®.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • City Clinical Hospital No.52

    Moscow, 123182

  • N.V. Sklifosovsky Research Institute of Emergency Medicine

    Moscow, 129090

Other trials in Russia

About this study

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.

Read the detailed description

Fortelyzin® (the active substance Forteplase) is a recombinant non-immunogenic staphylokinase with high fibrinselective thrombolytic activity. In a multicentre, randomised clinical trial in patients with ST-segment elevation myocardial infarction (FRIDOM), non-immunogenic staphylokinase was administered as a single intravenous bolus of 15 mg in all patients, regardless of bodyweight, and showed similar high reperfusion patency and fewer minor bleeding events compared with tenecteplase, as well as the absence of neutralising IgGs. Results of the multicentre, randomised clinical trial in patients with an acute ischaemic stroke (FRIDA) suggested that the non-immunogenic staphylokinase administrated as a single intravenous bolus of 10 mg in all patients within the 4-5 h after the onset of symptoms is non-inferior to alteplase. Mortality, symptomatic intracranial haemorrhage, and serious adverse events did not differ between treatment groups (Gusev EI, Martynov MYu, Nikonov AA et al. 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; 20(9): 721-728).

Complex coagulation and hematologic abnormalities, including significantly elevated D-dimer and fibrin/fibrinogen values are the distinct features identified in severe SARS-CoV-2. In the list of antithrombotic therapy drugs in conjunction with anticoagulant and antiplatelet therapy in patients with COVID-19, published by Liverpool Drug Interactions Group, fibrinolytic therapy is also included.

So the main objectives of this study are to assess the tolerability, safety and efficacy of inhaled usage of fibrinolytic agent the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with COVID-19.

Conditions
COVID-19
Being tested
Recombinant nonimmunogenic staphylokinase, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant nonimmunogenic staphylokinaseDrug

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

  • PlaceboDrug

    Also called Saline solution

    6 ml of 0.9% solution of NaCl for inhalation

Study groups in NCT05135546
Study groupRoleWhat they receive
ExperimentalExperimentalRecombinant 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.
Receives: Drug: Recombinant nonimmunogenic staphylokinase
Placebo controlPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days post randomization

Secondary outcomes (6)

  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

    Measured: 14 days post randomization

  2. Hospital length of stay

    The efficacy is evaluated in terms of the hospital length of stay

    Measured: 28 days post randomization

  3. Number of ICU-free days

    The efficacy is evaluated in terms of the number of ICU-free days

    Measured: 28 days post randomization

  4. Number of ventilation-free days

    The efficacy is evaluated in terms of the number of ventilation-free days

    Measured: 28 days post randomization

  5. Number of oxygen support-free days

    The efficacy is evaluated in terms of the number of oxygen support-free days

    Measured: 28 days post randomization

  6. SpO2 level

    The efficacy is evaluated in terms of the SpO2 level

    Measured: 7, 14 and 28 days post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2021
  2. Study start27 Dec 2021
  3. Primary completion1 Feb 2023
  4. Study completion31 May 2023

Why it stopped: No patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05135546
Sponsor's protocol ID
FORRIF
Acronym
FORRIF
Status last verified
Jun 2023
First submitted
24 Nov 2021
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34418399

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Recombinant nonimmunogenic staphylokinase in people with COVID-19, run by Supergene, LLC at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: No patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients discharged from the hospital with clinical status according to the WHO Ordinal Scale For Clinical Improvement - 3 points or less (time frame: 28 days post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05135546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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