COVID-19Phase 3NCT04501783
Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
A Phase 3 study testing Favipiravir and standard concomitant therapy in people with COVID-19, run by R-Pharm at 10 sites in Russia.
Trial summary
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Favipiravir and standard concomitant therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 10 sitesRussia
- Study dates
- 20 May 2020to 4 Aug 2020
- Phase
- Phase 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent form signed.
- Males and females aged 18-60 years;
- Diagnosis of coronavirus disease caused by SARS-CoV-2 (COVID-19) in a mild or moderate form (without respiratory failure).
- Duration of infection symptoms shall be no more than 6 days before randomization.
- SARS-CoV-2 infection should be verified by PCR at the screening.
- Ability to follow the protocol and fulfill all the clinical study procedures.
- Ability and willingness of the subjects and their sexual partners with retained childbearing potential to use reliable contraception methods throughout the study and for 3 months after the treatment completion.
- Willingness not to take alcohol throughout the study.
Who cannot join
- Age < 18 and > 60 years.
- Any etiotropic therapy of coronavirus SARS-CoV-2 (COVID-19) infection prior to the study.
- Moderate infection with respiratory failure, severe or extremely severe SARS-CoV-2 (COVID-19) disease.
- Respiratory failure (RR > 30/min, SpO2 ≤ 93 %) or the need for mechanical ventilation at the screening.
- Decreased level of consciousness (disorientation of place, time and personality), agitation at the screening.
- Unstable hemodynamics (systolic BP < 100 mm Hg or diastolic BP < 60 mm Hg) found at the screening.
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- Subtotal diffuse ground-glass induration of pulmonary tissue and pulmonary consolidation combined with reticular changes; involvement of ≥ 75 % of lung parenchyma; hydrothorax (CT findings corresponding to ≥ CT-4 according to Department of Health of Moscow guidelines).
- Presence of comorbidities:
- moderate or severe chronic obstructive pulmonary disease or asthma;
- severe chronic cardiovascular disorders (arrhythmia or conduction disorders, implanted pacemaker device, myocardial infarction or unstable angina in the medical history, heart failure);
- immunocompromised subjects (HIV, cancer, autoimmune diseases, immunodepressant therapy);
- severe obesity (body mass index [BMI] ≥ 40);
- diabetes mellitus;
- chronic renal failure;
- chronic moderate or severe hepatic disorders.
- Any of the following abnormal laboratory tests at the screening: AST or ALT level > 2.5 x upper normal level (UNL), platelet count < 50х109/L.
- Any history findings which, in the investigator's opinion, may complicate the interpretation of the study results or generate an additional risk for the subject due to his/her participation in the study.
- More than 2 CT diagnostic procedures within the last 6 months prior to randomization (except for chest CT no earlier than 4 days prior to enrollment).
- The subject takes the products significantly inhibiting CYP28С, and administration those products cannot be interrupted for the study duration.
- Malabsorption syndrome or another clinically relevant gastrointestinal disease which may affect the study product absorption (uncontrollable vomiting, diarrhea, ulcerative colitis, etc.).
- Pregnancy or breast-feeding; women with probable pregnancy at the screening, those planning to conceive during the study.
- Known (from the history) or suspected alcohol or psychotropic drug abuse; medicinal or illicit drug addiction.
- Mental disorders including those in the medical history.
- Condition or disease which, according to the investigator or medical monitor, will compromise the subject's safety or affect assessment of the study product safety.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
Medical center LLC "Neuroprofi"
Korolyov
Federal budgetary institution of science "Central Research Institute of Epidemiology" of Russian Federal Supervision Service for Consumer Rights Protection and People's Welfare
Moscow
Medical centers JSC "Medsi Group of Companies"
Moscow
State budgetary institution of health care of the city of Moscow "City Clinical Hospital №52 of the Moscow City Healthcare Department"
Moscow
State budgetary institution of health care of the city of Moscow "City Clinical Hospital №67 n.a. LA Vorokhobova of the Moscow City Healthcare Department"
Moscow
State budgetary institution of health care of the city of Moscow "Infectious Diseases Clinical Hospital №1 of the Moscow City Healthcare Department"
Moscow
Medical center LLC "Medical Center Eco-safety"
Saint Petersburg
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh
State Budgetary Healthcare Institution of the Moscow Region "Zhukovskaya City Clinical Hospital".
Zhukovskiy
About this study
Official title: Randomized Open-label Multicenter Parallel-group Study of Efficacy and Safety of TL-FVP-t vs. Standard of Care Therapy in Patients With Mild to Moderate Coronavirus Disease (SARS-CoV-2/COVID-19)
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
Read the detailed description
This was an open label, randomized, controlled, multicenter Phase 3 study of TL-FVP-t in outpatients and inpatients with mild to moderate COVID-19. After stratification by the severity of their disease (mild or moderate), age (18-44 or ≥ 45 years) and CT severity subjects were randomized at a rate of 2:1 to receive either TL-FVP-t + standard concomitant therapy or standard ethiptropic therapy (standard of care - SOC) including standard concomitant therapy. Standard ethiptropic therapy according to MoH of Russian Federation included umifenovir + intranasal recombinant interferon alpha, hydroxichloroquine, or chloroquine.
The dose regimen was the following: TL-FVP-t at a dose of 1800 mg BID on the Day 1 followed by 800 mg BID during the next 9 days. The study included the period of therapy (10 days) and follow-up period (18 days).
- Conditions
- COVID-19
- Being tested
- Favipiravir, Standard of care (SOC), standard concomitant therapy
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease
- Medical subject headings
- COVID-19, Respiration Disorders, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called TL-FVP-t, Koronavir
TL-FVP-t will be administered orally
Standard of care (SOC)Drug
SOC will include standard etiotropic therapy (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine) according to MoH of Russian Federation recomendations for COVID-19
standard concomitant therapyDrug
Standard of care according to MoH of Russian Federation recomendation for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| TL-FVP-t (favipiravir) Treatment Arm | Experimental | Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC); Days 2-10: 800 mg BID plus SOC. Receives: Drug: Favipiravir; Drug: standard concomitant therapy |
| Standard of Care Arm | Active comparator | Standard of Care including etiotropic therapy according to MoH of Russian Federation Recomendations for COVID-19 (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine, or mefloquine in recomended regimen) up to10 days Receives: Drug: Standard of care (SOC); Drug: standard concomitant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening
Measured: through Day 28
Time to viral clearance
To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling
Measured: through Day 28
Secondary outcomes (7)
Rate of clinical improvement at separate time points
To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement
Measured: Day 7
Rate of viral clearance at separate time points
To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points
Measured: Days 5 and 7
Time to body temperature normalization
To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.
Measured: through Day 28
Rate of resolution of lung changes on CT
To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT
Measured: Day 14
Rate of adverse drug reactions (ADR) and serious ADR
To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR
Measured: through Day 28
Rate of severe ADR
To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR
Measured: through Day 28
Rate therapy termination due to ADR
To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR
Measured: through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start20 May 2020
- Primary completion29 Jul 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501783
- Sponsor's protocol ID
- TL-FVP-t-01
- Status last verified
- Jan 2023
- First submitted
- 5 Aug 2020
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Multicenter Parallel-group Study of Efficacy and Safety of TL-FVP-t vs. Standard of Care Therapy in Patients With Mild to Moderate Coronavirus Disease (SARS-CoV-2/COVID-19)
- ClinicalTrials.gov ID
- NCT04501783
- Acronym / sponsor ID
- TL-FVP-t-01
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
Detailed description
This was an open label, randomized, controlled, multicenter Phase 3 study of TL-FVP-t in outpatients and inpatients with mild to moderate COVID-19. After stratification by the severity of their disease (mild or moderate), age (18-44 or ≥ 45 years) and CT severity subjects were randomized at a rate of 2:1 to receive either TL-FVP-t + standard concomitant therapy or standard ethiptropic therapy (standard of care - SOC) including standard concomitant therapy. Standard ethiptropic therapy according to MoH of Russian Federation included umifenovir + intranasal recombinant interferon alpha, hydroxichloroquine, or chloroquine.
The dose regimen was the following: TL-FVP-t at a dose of 1800 mg BID on the Day 1 followed by 800 mg BID during the next 9 days. The study included the period of therapy (10 days) and follow-up period (18 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL-FVP-t (favipiravir) Treatment Arm | Experimental | Drug: Favipiravir, Drug: standard concomitant therapyDay 1: favipiravir 1800 mg BID plus Standard of Care (SOC); Days 2-10: 800 mg BID plus SOC. |
| Standard of Care Arm | Active comparator | Drug: Standard of care (SOC), Drug: standard concomitant therapyStandard of Care including etiotropic therapy according to MoH of Russian Federation Recomendations for COVID-19 (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine, or mefloquine in recomended regimen) up to10 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent form signed.
- Males and females aged 18-60 years;
- Diagnosis of coronavirus disease caused by SARS-CoV-2 (COVID-19) in a mild or moderate form (without respiratory failure).
- Duration of infection symptoms shall be no more than 6 days before randomization.
- SARS-CoV-2 infection should be verified by PCR at the screening.
Key exclusion criteria (24 listed)
- Age < 18 and > 60 years.
- Any etiotropic therapy of coronavirus SARS-CoV-2 (COVID-19) infection prior to the study.
- Moderate infection with respiratory failure, severe or extremely severe SARS-CoV-2 (COVID-19) disease.
- Respiratory failure (RR > 30/min, SpO2 ≤ 93 %) or the need for mechanical ventilation at the screening.
- Decreased level of consciousness (disorientation of place, time and personality), agitation at the screening.
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 |
|---|---|---|
| FavipiravirAlso: TL-FVP-t, KoronavirTL-FVP-t will be administered orally | Drug | TL-FVP-t (favipiravir) Treatment Arm |
| Standard of care (SOC)SOC will include standard etiotropic therapy (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine) according to MoH of Russian Federation recomendations for COVID-19 | Drug | Standard of Care Arm |
| standard concomitant therapyStandard of care according to MoH of Russian Federation recomendation for COVID-19 | Drug | Standard of Care Arm, TL-FVP-t (favipiravir) Treatment Arm |
Primary outcome
Time to clinical improvement
Time frame: through Day 28
To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening
Time to viral clearance
Time frame: through Day 28
To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling
7 secondary outcomes
Rate of clinical improvement at separate time points
Time frame: Day 7
Rate of viral clearance at separate time points
Time frame: Days 5 and 7
Time to body temperature normalization
Time frame: through Day 28
Rate of resolution of lung changes on CT
Time frame: Day 14
Rate of adverse drug reactions (ADR) and serious ADR
Time frame: through Day 28
Rate of severe ADR
Time frame: through Day 28
Rate therapy termination due to ADR
Time frame: through Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Favipiravir and standard concomitant therapy in people with COVID-19, run by R-Pharm at 10 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 8 inclusion and 24 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 clinical improvement (time frame: through Day 28). The study lists 2 primary outcomes in all. 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 20 Jan 2023.