COVID-19Phase 3NCT05185284
Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19
A Phase 3 study testing Favipiravir and Remdesivir in people with COVID-19, run by Promomed, LLC at 6 sites in Russia.
Trial summary
This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration 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 and Remdesivir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 6 sitesRussia
- Study dates
- 11 Aug 2021to 30 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
- Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
- Confirmed case of COVID-19 at the time of screening based on SARS-CoV-2 RNA test using nucleic acid amplification (NAA) method. It is acceptable to include a patient with a presumptive COVID-19 diagnosis prior to receiving the results of SARS-CoV-2 RNA test made at the screening stage.
- Hospital admission due to COVID-19.
- Moderate severity infection with SARS-CoV-2:
- Clinical signs:
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- Mandatory: CT pattern typical of a viral lesion (lesion volume is minimal or moderate; CT 1-2).
- Additional (at least 1 of the following criteria):
- body temperature > 38 °C;
- RR > 22/min;
- shortness of breath on exertion;
- SpO2 < 95%;
- Serum CRP > 10 mg/L.
- 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. Reliable means of contraception are: sexual abstinence, use of condom in combination with spermicide.
- For men (optional): Consent to avoid sexual contact with pregnant women for the duration of the study and for 3 months after its completion.
- Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as men with infertility or a history of vasectomy.
Who cannot join
- Hypersensitivity to favipiravir, remdesivir and/or other components of the study drug.
- Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
- History of vaccination against COVID-19.
- History of presumptive or confirmed COVID-19 case of moderate, severe and extremely severe course of the disease.
- Use of favipiravir or remdesivir within 10 days prior to screening.
- The need to use drugs from the list of prohibited therapy.
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- Meeting the criteria for severe and extremely severe course of the disease.
- 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.
- Renal impairment (GFR < 60 ml/min) at the time of screening.
- History of gout.
- 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 (see Appendix 2).
- 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
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Regional budgetary health care institution "Ivanovo Clinical Hospital named after Kuvaevs"
Ivanovo, 153025
State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 24 of the Department of Healthcare of the City of Moscow"
Moscow, 127015
State Clinical Hospital №50
Moscow
Regional Clinic Hospital of Ryazan
Ryazan
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® (Favipiravir) for Parenteral Administration (PROMOMED RUS LLC, Russia) in Hospitalized Patients With COVID-19
This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration 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, 217 eligible patients hospitalized with COVID-19 pneumonia were randomized at a 1:1 ratio to receive either Favipiravir intravenously by drip infusion for 2 hours 1600 mg twice a day (BID) on Day 1 followed by 800 mg BID on Days 2-14 (1600/800 mg), or SOC. The course of treatment by Favipiravir is 10 days.
- Conditions
- COVID-19
- Being tested
- Favipiravir, Remdesivir
- Keywords
- SARS-CoV-2, Areplivir, 2019-nCoV, Favipiravir, Pneumonia, Coronavirus Infections
- Medical subject headings
- COVID-19, Pneumonia, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called Areplivir
400 mg, lyophilizate for preparation of concentrate for solution for infusion
FavipiravirDrug
200 mg coated tablets
RemdesivirDrug
100 mg, lyophilizate for preparation of concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir (Areplivir) | Experimental | Arm 1 (n=106) receives the study drug Areplivir for parenteral administration as follows: Day 1 1600 mg 2 times a day, Day 2-10 800 mg 2 times a day. Administration will be done intravenously by drip infusion for 2 hours. The course of treatment is 10 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=108) 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 by decision of the investigator and taking into account the availability of drugs at the study site. Might include Favipiravir tab, Remdesivir 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: Favipiravir; Drug: Remdesivir |
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 WHO 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 (9)
Rate of Clinical Status Improvement
Rate of clinical status improvement by WHO categorical ordinal scale of clinical status improvement by 2 or more categories at Visits 2 (Day 5) and 4 (Day 14)
Measured: 14 days
Rate of Clinical Status Improvement
Percentage of patients with clinical status of 0 and 1 point according to the WHO categorical ordinal scale of clinical improvement on Days 5, 10 and 14.
Measured: 14 Days
End of Fever on Days of study
Percentage of patients with fever disappearance (body temperature < 37,2 °C in 3 consecutive measurements without antipyretic medication) an Days 5, 10 and 14.
Measured: 14 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: 14 Days
Rate of Viral Elimination
Percentage of patients with SARS-CoV-2 elimination (negative test for SARS-CoV-2 by NAA method) on Days 5, 10, and 14.
Measured: 14 days
Rate of Transfer to the Intensive Care Unit
Percentage of patients transferred to intensive care unit
Measured: 28 days
Rate of the Use of Non-invasive Lung Ventilation
Percentage of cases with non-invasive lung ventilation
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 posted11 Jan 2022
- Study start11 Aug 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Solyur Pharmaceuticals Group
- Responsible party
- Sponsor
- Investigators
- Dmitriy Pushkar, MD, Academic, Principal investigator, Moscow State Clinical Hospital №50
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185284
- Sponsor's protocol ID
- FAV-052021
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. 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® (Favipiravir) for Parenteral Administration (PROMOMED RUS LLC, Russia) in Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05185284
- Acronym / sponsor ID
- FAV-052021
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Areplivir, 2019-nCoV, Favipiravir, Pneumonia, Coronavirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Collaborators
- Solyur Pharmaceuticals Group
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 11 Jan 2022 (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.
This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration 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, 217 eligible patients hospitalized with COVID-19 pneumonia were randomized at a 1:1 ratio to receive either Favipiravir intravenously by drip infusion for 2 hours 1600 mg twice a day (BID) on Day 1 followed by 800 mg BID on Days 2-14 (1600/800 mg), or SOC. The course of treatment by Favipiravir is 10 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=106) receives the study drug Areplivir for parenteral administration as follows: Day 1 1600 mg 2 times a day, Day 2-10 800 mg 2 times a day. Administration will be done intravenously by drip infusion for 2 hours. The course of treatment is 10 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: Favipiravir, Drug: RemdesivirArm 2 (n=108) 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 by decision of the investigator and taking into account the availability of drugs at the study site. Might include Favipiravir tab, Remdesivir 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 (16 listed)
- Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
- Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
- Confirmed case of COVID-19 at the time of screening based on SARS-CoV-2 RNA test using nucleic acid amplification (NAA) method. It is acceptable to include a patient with a presumptive COVID-19 diagnosis prior to receiving the results of SARS-CoV-2 RNA test made at the screening stage.
- Hospital admission due to COVID-19.
- Moderate severity infection with SARS-CoV-2:
Key exclusion criteria (22 listed)
- Hypersensitivity to favipiravir, remdesivir and/or other components of the study drug.
- Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
- History of vaccination against COVID-19.
- History of presumptive or confirmed COVID-19 case of moderate, severe and extremely severe course of the disease.
- Use of favipiravir or remdesivir within 10 days prior to 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: Areplivir400 mg, lyophilizate for preparation of concentrate for solution for infusion | Drug | Favipiravir (Areplivir) |
| Favipiravir200 mg coated tablets | Drug | Standard of care |
| Remdesivir100 mg, lyophilizate for preparation of concentrate for solution for infusion | 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 WHO 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
9 secondary outcomes
Rate of Clinical Status Improvement
Time frame: 14 days
Rate of Clinical Status Improvement
Time frame: 14 Days
End of Fever on Days of study
Time frame: 14 Days
Change in the Level of Lung Damage According to CT
Time frame: 14 Days
Rate of Viral Elimination
Time frame: 14 days
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
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 11 Jan 2022.
- Individual participant dataSharing planned: Yes
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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, MD, Academic principal investigator
Moscow State Clinical Hospital №50
6 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 Remdesivir in people with COVID-19, run by Promomed, LLC at 6 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 16 inclusion and 22 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 11 Jan 2022.