Covid19Phase 2HIBISCUSNCT04860518

Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

A Phase 2 study testing IFN beta-1a and Dexamethasone in people with Covid19, run by Faron Pharmaceuticals Ltd at 4 sites in United States.

Terminated

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

Official record

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Trial summary

This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: IFN beta-1a and Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 4 sitesUnited States
Study dates: 23 Aug 2021to 4 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age ≥18 years
Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
Respiratory symptom onset no more than 7 days prior to hospital arrival
Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available

Who cannot join

Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
Currently receiving IFN-beta-1a therapy
Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
Participation in another concurrent interventional pharmacotherapy trial during the study period

Show all 11Show fewer

Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
Subject is not expected to survive for 24 hours
Subject has liver failure (Child-Pugh grade C)
Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232
Newton-Wellesley Hospital
Newton, Massachusetts, 02462

Other trials in United States

About this study

Official title: A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection

Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.

Conditions: Covid19
Being tested: IFN beta-1a, Dexamethasone
Medical subject headings: COVID-19

What participants receive

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

IFN beta-1aDrug
Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
DexamethasoneDrug
Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised

Study groups in NCT04860518
Study group	Role	What they receive
IV IFN beta-1a	Experimental	Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline. Receives: Drug: IFN beta-1a
IV Dexamethasone	Active comparator	Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone. Receives: Drug: Dexamethasone

What is being measured

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

Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
WHO 9-point ordinal scale:
0 - No detectable infection
1. - Not hospitalized, no limitations on activities
2. - Not hospitalized, limitation on activities
3. - Hospitalized, not requiring supplemental oxygen
4. - Hospitalized, requiring supplemental oxygen
5. - Hospitalized, on non-invasive ventilation or high flow oxygen devices
6. - Hospitalized, on invasive mechanical ventilation
7. - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)
8. - Death
Measured: Day 14

Secondary outcomes (2)

In-hospital Mortality at Day 28 and Day 90
Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial
Measured: Day 28 and Day 90
Overall (All-cause) Mortality at Day 28 and Day 90
Percentage of participants per study group that die within 28 days or 90 days from starting the study
Measured: Day 28 and Day 90

Timeline

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

23 Aug 20214 Apr 2022

First posted27 Apr 2021
Study start23 Aug 2021
Primary completion4 Apr 2022
Study completion4 Apr 2022

Why it stopped: The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04860518
Sponsor's protocol ID: FP1CLI017
Acronym: HIBISCUS
Status last verified: Jul 2023
First submitted: 22 Apr 2021
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection
ClinicalTrials.gov ID: NCT04860518
Acronym / sponsor ID: HIBISCUS / FP1CLI017
Conditions: Covid19
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time
Enrolment: 7 participants (actual)
Lead sponsor: Faron Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Study start: 23 Aug 2021 (actual)
Primary completion: 4 Apr 2022 (actual)
Study completion: 4 Apr 2022 (actual)
First posted: 27 Apr 2021 (actual)
Results: Posted 14 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IV IFN beta-1a	Experimental	Drug: IFN beta-1aPatients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IV Dexamethasone	Active comparator	Drug: DexamethasonePatients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥18 years
Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
Respiratory symptom onset no more than 7 days prior to hospital arrival
Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available

Key exclusion criteria (11 listed)

Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
Currently receiving IFN-beta-1a therapy
Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IFN beta-1aTreated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised	Drug	IV IFN beta-1a
DexamethasoneTreated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised	Drug	IV Dexamethasone

Primary outcome

Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
Time frame: Day 14
WHO 9-point ordinal scale: 0 - No detectable infection 1. - Not hospitalized, no limitations on activities 2. - Not hospitalized, limitation on activities 3. - Hospitalized, not requiring supplemental oxygen 4. - Hospitalized, requiring supplemental oxygen 5. - Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. - Hospitalized, on invasive mechanical ventilation 7. - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. - Death

2 secondary outcomes

In-hospital Mortality at Day 28 and Day 90
Time frame: Day 28 and Day 90
Overall (All-cause) Mortality at Day 28 and Day 90
Time frame: Day 28 and Day 90

Results and safety

Results posted to the registry on 14 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV IFN Beta-1a	3	2
IV Dexamethasone	4	3

Primary outcome: Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale

Time frame: Day 14. Mean (Standard Deviation). Unit: units on a scale

Measure	IV IFN Beta-1a n = 2	IV Dexamethasone n = 2
Value	2 (0)	2 (0)

Population analysed: Only 4 patients had analyzable data on D14

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV IFN Beta-1a	0 of 2 (0%)	1 of 2 (50%)	0 of 2
IV Dexamethasone	2 of 3 (66.7%)	2 of 3 (66.7%)	0 of 3

Limitations and caveats (from the sponsor): No formal statistical hypotheses were analysed due the early termination of the study with only 5 dosed subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Talmor, MD MPH, principal investigator

Deaconess Medical Center, Spokane, Washington

Adit Ginde, MD MPH, principal investigator

University of Colorado School of Medicine

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IFN beta-1a and Dexamethasone in people with Covid19, run by Faron Pharmaceuticals Ltd at 4 sites in United States.

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 5 inclusion and 11 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 21 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 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale (time frame: Day 14). 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 NCT04860518.

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 21 Jul 2023.