Covid19Phase 2NCT04498377
Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
A Phase 2 study testing F-652 in people with Covid19, run by EVIVE Biotechnology at 1 site in United States.
Trial summary
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- F-652
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 24 Mar 2021
- 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
- Willing to provide informed consent and able to comply with protocol requirements
- 18 years or older
- Has a COVID-19 diagnosis confirmed by PCR
- Hospitalized within 5 days and meets the following criteria at screening:
- Peripheral capillary oxygen saturation (SpO2) ≤ 93% on room air or SpO2 ≥93% on ≤10 liters per minute of supplemental oxygen via nasal cannula
- Radiographic (chest X-ray, computed tomography scan, or ultrasound) evidence of bilateral pulmonary infiltrates consistent with SARS-CoV-2/COVID-19
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- Clinical symptoms consistent with COVID-19 per Investigator judgement
- Body mass index between 18 to 40 kg/m2
- If of reproductive potential, willing to abstain or agree to the use of highly effective contraception
Who cannot join
- Respiratory failure at screening
- History of heart failure
- History of COPD or bronchial asthma
- Active TB or history of TB of the following types
- Uncontrolled arrhythmia within 3 months prior to randomization
- Heart disease of the following types
Show all 20Show fewer
- Moderate to severe renal insufficiency
- Abnormal white cell and platelet counts
- History of transplantation of vital organs (e.g., heart, lung, liver, and/or kidney);
- Malignant tumor
- Uncontrolled systemic or local autoimmune or inflammatory disease besides SARS-CoV-2
- Unhealed wounds, active gastric ulcer, had surgery
- Received other investigational therapeutic products
- Used interferon therapies
- History of HIV infection, hepatitis B, and/or hepatitis C
- Known serious allergic reaction or hypersensitivity to components of F-652
- Pregnant or breastfeeding
- History of drug abuse or use of narcotics
- Treated with immunomodulators or immunosuppressants
- Other conditions resulting in increased risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Medicine
New Orleans, Louisiana, 70112
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR. Eligible patients will have moderate to severe COVID-19 symptoms within 5 days post hospitalization and a positive COVID-19 testing.
Read the detailed description
The study is planned to include 4 cohorts, with enrolled patients being randomized 1:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows:
- Cohort 1 (sentinel cohort): Four patients will receive either dose level 1 F-652 or placebo. Upon completion of sentinel, the Data Monitoring Committee will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 2.
- Cohort 2: Fourteen patients will receive either dose level 1 F-652 or placebo. Upon completion of Cohort 2, the DMC will convene and review all available safety data to determine if the study can proceed to the next dose level.
- Cohort 3 (sentinel cohort): Four patients will receive either dose level 2 F-652 or placebo. Upon completion of sentinel dosing, the DMC will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 4.
- Cohort 4: Sixteen patients will receive either dose level 2 F-652 or placebo. Treatment will begin on Day 1 following randomization. Patients assigned to active drug will receive a total of 2 doses of F-652 (1 IV infusion on Day 1 and 1 IV infusion on Day 8). Patients assigned to placebo will receive identical IV infusions of placebo vehicle on Days 1 and 8. All patients will receive available supportive and antiviral therapies as standard of care. Efficacy will be assessed on Days 15 and 29. Patients will be followed for safety until Day 60.
The primary efficacy endpoint is the proportion of patients with a ≥2-point increase in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29.
The secondary efficacy endpoints include the proportion of patients with a ≥2-point increase in the NIAID 8-point ordinal scale from baseline to Day 15, mortality rate by Days 15 and 29, percentage of patients who have recovered and discharged from the hospital by Days 15 and 29, and percentage of patients progressed to severe/critical disease by Day 15.
The safety endpoints include all cause treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); change from screening (baseline) in clinical symptoms and abnormal vital signs, abnormal laboratory tests; and relationship of any AEs with F-652 treatment.
The exploratory endpoints include time to negative SARS-CoV-2 PCR test from randomization; and changes in pharmacodynamic parameters.
- Conditions
- Covid19
- Being tested
- F-652, 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.
F-652Biological
IL-22 fusion protein administered intravenously
PlaceboBiological
Placebo administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| F-652 | Experimental | Patient receives standard care plus F-652 Receives: Biological: F-652 |
| Placebo | Placebo comparator | Patient receives standard care plus placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIAID 8-point Ordinal Scale
The proportion of patients with a greater or equal 2-point change in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29.
The NIAID 8-point ordinal scale includes the following grades:
- Death;
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation;
- Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
- Not hospitalized, limitation on activities and/or requiring home oxygen; and
- Not hospitalized, no limitations on activities.
Measured: Study day 1 before dose to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start26 Jan 2021
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Why it stopped: There have been significant changes in the FDA guidelines and clinical standard of care
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine M Bojanowski, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498377
- Sponsor's protocol ID
- GC-652-04
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2020
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT04498377
- Acronym / sponsor ID
- GC-652-04
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There have been significant changes in the FDA guidelines and clinical standard of care
- Enrolment
- 1 participants (actual)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR. Eligible patients will have moderate to severe COVID-19 symptoms within 5 days post hospitalization and a positive COVID-19 testing.
Detailed description
The study is planned to include 4 cohorts, with enrolled patients being randomized 1:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows:
- Cohort 1 (sentinel cohort): Four patients will receive either dose level 1 F-652 or placebo. Upon completion of sentinel, the Data Monitoring Committee will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 2.
- Cohort 2: Fourteen patients will receive either dose level 1 F-652 or placebo. Upon completion of Cohort 2, the DMC will convene and review all available safety data to determine if the study can proceed to the next dose level.
- Cohort 3 (sentinel cohort): Four patients will receive either dose level 2 F-652 or placebo. Upon completion of sentinel dosing, the DMC will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 4.
- Cohort 4: Sixteen patients will receive either dose level 2 F-652 or placebo. Treatment will begin on Day 1 following randomization. Patients assigned to active drug will receive a total of 2 doses of F-652 (1 IV infusion on Day 1 and 1 IV infusion on Day 8). Patients assigned to placebo will receive identical IV infusions of placebo vehicle on Days 1 and 8. All patients will receive available supportive and antiviral therapies as standard of care. Efficacy will be assessed on Days 15 and 29. Patients will be followed for safety until Day 60.
The primary efficacy endpoint is the proportion of patients with a ≥2-point increase in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29.
The secondary efficacy endpoints include the proportion of patients with a ≥2-point increase in the NIAID 8-point ordinal scale from baseline to Day 15, mortality rate by Days 15 and 29, percentage of patients who have recovered and discharged from the hospital by Days 15 and 29, and percentage of patients progressed to severe/critical disease by Day 15.
The safety endpoints include all cause treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); change from screening (baseline) in clinical symptoms and abnormal vital signs, abnormal laboratory tests; and relationship of any AEs with F-652 treatment.
The exploratory endpoints include time to negative SARS-CoV-2 PCR test from randomization; and changes in pharmacodynamic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-652 | Experimental | Biological: F-652Patient receives standard care plus F-652 |
| Placebo | Placebo comparator | Biological: PlaceboPatient receives standard care plus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing to provide informed consent and able to comply with protocol requirements
- 18 years or older
- Has a COVID-19 diagnosis confirmed by PCR
- Hospitalized within 5 days and meets the following criteria at screening:
- Peripheral capillary oxygen saturation (SpO2) ≤ 93% on room air or SpO2 ≥93% on ≤10 liters per minute of supplemental oxygen via nasal cannula
Key exclusion criteria (20 listed)
- Respiratory failure at screening
- History of heart failure
- History of COPD or bronchial asthma
- Active TB or history of TB of the following types
- Uncontrolled arrhythmia within 3 months prior to randomization
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 |
|---|---|---|
| F-652IL-22 fusion protein administered intravenously | Biological | F-652 |
| PlaceboPlacebo administered intravenously | Biological | Placebo |
Primary outcome
NIAID 8-point Ordinal Scale
Time frame: Study day 1 before dose to day 29
The proportion of patients with a greater or equal 2-point change in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29. The NIAID 8-point ordinal scale includes the following grades: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; and 8. Not hospitalized, no limitations on activities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christine M Bojanowski, MD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-652 in people with Covid19, run by EVIVE Biotechnology at 1 site 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 9 inclusion and 20 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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 21 Dec 2023). 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?
NIAID 8-point Ordinal Scale (time frame: Study day 1 before dose to day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2023.