COVID-19Phase 2NCT04358549
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
A Phase 2 study testing Favipiravir in people with COVID-19, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 8 sites in United States.
Trial summary
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Favipiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Apr 2020to 30 Oct 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adults (18 to 80 years old):
- within 72 hours of their hospitalization for infection with Severe Acute Respiratory Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,
- within 72 hours of the latest Polymerase Chain Reaction (PCR) positive result and within 7 days of the 1st PCR positive result for SARS-CoV-2. (The latest PCR could be the only PCR result.), AND,
- within 10 days of onset of any COVID-19 symptoms.
Who cannot join
- Subject has a concomitant bacterial respiratory infection unless cleared by the Sponsor
- Subject has a history of abnormalities of uric acid metabolism unless cleared by the Sponsor.
- Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug targeting a viral RNA polymerase
- Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). Dexamethasone 6 mg daily (PO or IV) for 10 days is permitted.
- Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
- Has previously received favipiravir within the past 30 days
Show all 14Show fewer
- Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.
- Has liver impairment greater than Child-Pugh A.
- Has a history of alcohol or drug abuse in the previous 6 months.
- Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- Has taken another investigational drug within the past 30 days.
- Is on another antiviral or is participating in another clinical trial for the treatment of COVID-19
- Subject is on a ventilator at the time of study entry
- Is deemed by the Investigator to be ineligible for any reason.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boston Medical Center
Boston, Massachusetts, 02118
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Houston Methodist Hospital
Houston, Texas, 77030
University of Miami Miller School of Medicine
Miami, Florida, 33136
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07960
HonorHealth
Scottsdale, Arizona, 85258
UMass Memorial Health Care
Worcester, Massachusetts, 01605
About this study
Official title: Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
Read the detailed description
This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone.
The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days.
The study will have 14 days of treatment and 46 days of follow-up.
Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US.
- Conditions
- COVID-19
- Being tested
- Favipiravir, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
Standard of CareOther
Standard of Care for individual study site as determined by each hospital's protocol
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir Treatment Arm | Experimental | Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC Receives: Drug: Favipiravir |
| Standard of Care Arm | Other | Standard of Care for 14 days Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Viral Clearance
To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling
Measured: Day 29
Secondary outcomes (5)
Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale
To determine the clinical benefit of administering favipiravir plus SOC compared to SOC alone, clinical benefit will be measured using a study-specified ordinal scale on Day 15 in adult patients hospitalized with COVID-19.
Measured: on Day 15
Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge
The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to, or are being monitored in hospital. Six simple physiological parameters form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. The time to aggregate NEWS2 score of ≤ 2 (sustained for at least 72 hours) or hospital discharge is analyzed.
Measured: through Day 29
Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax
Measurement of maximum plasma concentration
Measured: through Day 14
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin
Measurement of minimum plasma concentration
Measured: through Day 14
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)
Measurement of the area under the curve of plasma concentration versus time profile
Measured: through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start17 Apr 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Model description
- Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358549
- Sponsor's protocol ID
- FAVI-COV-US201
- Status last verified
- Mar 2022
- First submitted
- 16 Apr 2020
- Last updated
- 29 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finberg RW, Ashraf M, Julg B, Ayoade F, Marathe JG, Issa NC, Wang JP, Jaijakul S, Baden LR, Epstein C. US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19. Open Forum Infect Dis. 2021 Dec 7;8(12):ofab563. doi: 10.1093/ofid/ofab563. eCollection 2021 Dec.
PubMed 34888401
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19
- ClinicalTrials.gov ID
- NCT04358549
- Acronym / sponsor ID
- FAVI-COV-US201
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 29 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
Detailed description
This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone.
The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days.
The study will have 14 days of treatment and 46 days of follow-up.
Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.
| Arm | Type | Receives |
|---|---|---|
| Favipiravir Treatment Arm | Experimental | Drug: FavipiravirDay 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC |
| Standard of Care Arm | Other | Other: Standard of CareStandard of Care for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- within 72 hours of their hospitalization for infection with Severe Acute Respiratory Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,
- within 72 hours of the latest Polymerase Chain Reaction (PCR) positive result and within 7 days of the 1st PCR positive result for SARS-CoV-2. (The latest PCR could be the only PCR result.), AND,
- within 10 days of onset of any COVID-19 symptoms.
Key exclusion criteria (14 listed)
- Subject has a concomitant bacterial respiratory infection unless cleared by the Sponsor
- Subject has a history of abnormalities of uric acid metabolism unless cleared by the Sponsor.
- Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug targeting a viral RNA polymerase
- Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). Dexamethasone 6 mg daily (PO or IV) for 10 days is permitted.
- Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
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 |
|---|---|---|
| FavipiravirFavipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets | Drug | Favipiravir Treatment Arm |
| Standard of CareStandard of Care for individual study site as determined by each hospital's protocol | Other | Standard of Care Arm |
Primary outcome
Time to Viral Clearance
Time frame: Day 29
To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling
5 secondary outcomes
Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale
Time frame: on Day 15
Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge
Time frame: through Day 29
Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax
Time frame: through Day 14
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin
Time frame: through Day 14
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)
Time frame: through Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34888401Finberg RW, Ashraf M, Julg B, Ayoade F, Marathe JG, Issa NC, Wang JP, Jaijakul S, Baden LR, Epstein C. US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19. Open Forum Infect Dis. 2021 Dec 7;8(12):ofab563. doi: 10.1093/ofid/ofab563. eCollection 2021 Dec.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 Favipiravir in people with COVID-19, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 8 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 29 Mar 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?
Time to Viral Clearance (time frame: Day 29). 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 NCT04358549, 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 29 Mar 2022.