COVID-19Phase 3NCT04542694
Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
A Phase 3 study testing Favipiravir in people with COVID-19, run by Promomed, LLC at 5 sites in Russia.
Trial summary
This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia. 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
- 200 participants
- Where
- 5 sitesRussia
- Study dates
- 21 May 2020to 20 Aug 2020
- Phase
- Phase 3
- 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
- Signing and dating of the Informed Consent Form of the Patient Information Leaflet (PIL) by patients.
- Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
- No difficulty with oral medication (e.g. swallowing disorder).
- Patient diagnosed with "Coronavirus infection caused by SARS-CoV-2 (confirmed)1, moderate severity form*" established in accordance with the Interim Guidelines of the Russian Ministry of Health for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (revision 6 of 28.04.2020).
- Moderate severity form: fever above 38 °C, BR above 22/min, dyspnea during exercise, pneumonia (confirmed by lung CT), SpO2 < 95%, C reactive protein (CRP) serum level above 10 mg/l.
- Patient should be hospitalized no more than 48 hours before the start of the study therapy.
- Positive PCR result for presence of SARS-CoV-2 RNA at screening phase (results obtained within 7 days prior to screening are appropriate).
- Patient's consent to use reliable contraceptive methods throughout the study and within 1 month for women and 3 months for men after its completion. Persons eligible for participation in the study: - Women who have a negative pregnancy test and use the following contraceptives: barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or double barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vaulted cap) plus spermicide (foam/gel/film/cream/suppository)). Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause more than 1 year) or men with preserved reproductive function who use barrier contraceptives, as well as men with infertility or vasectomy in the past medical history.
Who cannot join
- Hypersensitivity to favipiravir and/or other components of the study drug.
- Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
- The need to use drugs from the list of prohibited therapy.
- Need for treatment in the intensive care unit.
- Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
- Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 45 ml/min) at the time of screening.
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- Positive testing for HIV, syphilis, hepatitis B and/or C.
- Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
- Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
- Malignancies in the past medical history.
- Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
- Schizophrenia, schizoaffective disorder, bipolar disorder, or other history of mental pathology or suspicion of their presence at the time of screening.
- Severe, decompensated or unstable somatic diseases (any disease or condition that threaten the patient's life or impair the patient's prognosis, and also make it impossible for him/her to participate in the clinical study).
- Any history data that the investigating physician believes could lead to complication in the interpretation of the study results or create an additional risk to the patient as a result of his/her participation in the study.
- Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
- Pregnant or nursing women or women planning pregnancy.
- Participation in another clinical study for 3 months prior to inclusion in the study.
- Other conditions that, according to the physician investigator, prevent the patient from being included in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
State Clinical Hospital №50
Moscow
Regional Clinic Hospital of Ryazan
Ryazan
City Hospital N40 of Kurortny District
Saint Petersburg
Medical institute Ogarev Mordovia State university
Saransk
Smolensk clinical hospital №1
Smolensk
About this study
Official title: Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19
This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
Read the detailed description
Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.
- Conditions
- COVID-19
- Being tested
- Favipiravir, Standard of care
- Keywords
- Favipiravir, Areplivir, COVID-19, SARS-CoV-2, 2019-nCoV
- 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
Also called AREPLIVIR
200 mg coated tablets
Standard of careDrug
Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir (Areplivir) | Experimental | Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:
on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient. Receives: Drug: Favipiravir |
| Standard of care | Active comparator | Arm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes.
Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Clinical Status Improvement
Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10 WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Measured: By Visit 3, approximately 10 days
Time to Clinical Improvement
Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement.
Measured: 28 days
Secondary outcomes (7)
Rate of Viral Elimination by Day 10
Percentage of patients with elimination (clearance) of COVID-19 according to PCR data by day 10 (negative PCR results).
Measured: 10 days
Time Before the End of Fever
Time (in days) before the end of fever (body temperature < 37.2 ° C for 3 consecutive days without antipyretic medication).
Measured: 28 days
Change in the Level of Lung Damage According to CT
Assessment of lung injury (degree of damage by "empirical" visual scale and % of patients) according to CT data comparing to baseline. The number of patients in whom by the end of therapy there was an improvement in the condition of the lungs (a decrease in the volume of the lesion according to CT)
Measured: Days 15, 21, 28
Rate of Transfer to the Intensive Care Unit
Percentage of patients transferred to intensive care unit (% of patients).
Measured: 28 Days
Rate of the Use of Non-invasive Lung Ventilation
Percentage of cases with non-invasive lung ventilation (% of patients).
Measured: 28 Days
Rate of the Use of Mechanical Ventilation
Percentage of cases with mechanical lung ventilation (% of patients)
Measured: 28 Days
Mortality
Incidence of fatal cases (% of patients)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start21 May 2020
- Primary completion10 Aug 2020
- Study completion20 Aug 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.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitriy Pushkar, Principal investigator, Moscow State Clinical Hospital №50
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542694
- Sponsor's protocol ID
- FAV052020
- Status last verified
- Nov 2020
- First submitted
- 4 Sep 2020
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19
- ClinicalTrials.gov ID
- NCT04542694
- Acronym / sponsor ID
- FAV052020
- Conditions
- COVID-19
- Keywords
- Favipiravir, Areplivir, COVID-19, SARS-CoV-2, 2019-nCoV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
Detailed description
Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir (Areplivir) | Experimental | Drug: FavipiravirArm 1 (n=100) receives the study drug Areplivir film-coated tablets: on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient. |
| Standard of care | Active comparator | Drug: Standard of careArm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes. Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signing and dating of the Informed Consent Form of the Patient Information Leaflet (PIL) by patients.
- Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
- No difficulty with oral medication (e.g. swallowing disorder).
- Patient diagnosed with "Coronavirus infection caused by SARS-CoV-2 (confirmed)1, moderate severity form*" established in accordance with the Interim Guidelines of the Russian Ministry of Health for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (revision 6 of 28.04.2020).
- Moderate severity form: fever above 38 °C, BR above 22/min, dyspnea during exercise, pneumonia (confirmed by lung CT), SpO2 < 95%, C reactive protein (CRP) serum level above 10 mg/l.
Key exclusion criteria (18 listed)
- Hypersensitivity to favipiravir and/or other components of the study drug.
- Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
- The need to use drugs from the list of prohibited therapy.
- Need for treatment in the intensive care unit.
- Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of 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: AREPLIVIR200 mg coated tablets | Drug | Favipiravir (Areplivir) |
| Standard of careDrug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator. Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc. | Drug | Standard of care |
Primary outcome
Rate of Clinical Status Improvement
Time frame: By Visit 3, approximately 10 days
Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10 WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Time to Clinical Improvement
Time frame: 28 days
Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement.
7 secondary outcomes
Rate of Viral Elimination by Day 10
Time frame: 10 days
Time Before the End of Fever
Time frame: 28 days
Change in the Level of Lung Damage According to CT
Time frame: Days 15, 21, 28
Rate of Transfer to the Intensive Care Unit
Time frame: 28 Days
Rate of the Use of Non-invasive Lung Ventilation
Time frame: 28 Days
Rate of the Use of Mechanical Ventilation
Time frame: 28 Days
Mortality
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- 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.
Dmitriy Pushkar principal investigator
Moscow State Clinical Hospital №50
5 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 in people with COVID-19, run by Promomed, LLC at 5 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 18 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 5 Nov 2020). 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?
Rate of Clinical Status Improvement (time frame: By Visit 3, approximately 10 days). 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 5 Nov 2020.