Sars-CoV2Phase 2NCT04346628
Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19
A Phase 2 study testing Favipiravir in people with Sars-CoV2 and COVID-19, run by Stanford University at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Favipiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2020to 16 Apr 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
- Diagnosis of COVID-19 disease:
- If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.
- If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent
- Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
- Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
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- Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
- Females must have a negative pregnancy test at screening
- Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
Who cannot join
- Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
- History of abnormal uric acid metabolism.
- History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
- Abnormal laboratory test results at screening:
- Use of 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). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
- Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
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- Previously received favipiravir within the past 30 days.
- Advanced kidney disease
- Advanced liver disease
- History of alcohol or drug abuse in the previous two years.
- Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
- Taken another investigational drug within the past 30 days.
- Seemed by the Investigator to be ineligible for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.
- Being tested
- Favipiravir, Placebo, Standard of care treatment
- 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 administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
PlaceboDrug
Placebo to match favipiravir administered orally through day 10.
Standard of care treatmentOther
Standard of care treatment for COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir | Experimental | In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28. Receives: Drug: Favipiravir; Other: Standard of care treatment |
| Placebo | Active comparator | In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28. Receives: Drug: Placebo; Other: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
Measured: Up to 28 days
Secondary outcomes (7)
Sars-CoV-2 Viral Load
Viral load (nucleic acid) will be assessed by RT-PCR Ct over time. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Measured: Up to 28 days
Count of Participants With Clinical Worsening of COVID-19 Disease
Clinical worsening is reported as the number of participants with hospitalization or emergency department (ED) visits.
Measured: Up to 28 days
Count of Participants With Development of SARS-CoV-2 Antibodies
Measured: Up to 28 days
Time Until Cessation of Symptoms
Time until cessation of symptoms is reported as days until initial resolution and sustained resolution of symptoms.
Measured: Up to 28 days
Count of Participant With Absence of Development of Any Symptoms
This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment
Measured: Up to 28 days
Cmax of Favipiravir
Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
Measured: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
Cmin of Favipiravir
Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Measured: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start12 Jul 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne (Bonnie) A Maldonado, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346628
- Sponsor's protocol ID
- 56032
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2020
- Last updated
- 13 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share individual participant data (IPD).
Publications
Holubar M, Subramanian A, Purington N, Hedlin H, Bunning B, Walter KS, Bonilla H, Boumis A, Chen M, Clinton K, Dewhurst L, Epstein C, Jagannathan P, Kaszynski RH, Panu L, Parsonnet J, Ponder EL, Quintero O, Sefton E, Singh U, Soberanis L, Truong H, Andrews JR, Desai M, Khosla C, Maldonado Y. Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Clin Infect Dis. 2022 Nov 30;75(11):1883-1892. doi: 10.1093/cid/ciac312.
PubMed 35446944Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
PubMed 33624010
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
- ClinicalTrials.gov ID
- NCT04346628
- Acronym / sponsor ID
- 56032
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 21 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir | Experimental | Drug: Favipiravir, Other: Standard of care treatmentIn addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28. |
| Placebo | Active comparator | Drug: Placebo, Other: Standard of care treatmentIn addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of COVID-19 disease:
- Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
- Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
Key exclusion criteria (13 listed)
- Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
- History of abnormal uric acid metabolism.
- History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
- Abnormal laboratory test results at screening:
- Use of 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). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
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 administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10). | Drug | Favipiravir |
| PlaceboPlacebo to match favipiravir administered orally through day 10. | Drug | Placebo |
| Standard of care treatmentStandard of care treatment for COVID-19 infection | Other | Favipiravir, Placebo |
Primary outcome
Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
Time frame: Up to 28 days
Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
7 secondary outcomes
Sars-CoV-2 Viral Load
Time frame: Up to 28 days
Count of Participants With Clinical Worsening of COVID-19 Disease
Time frame: Up to 28 days
Count of Participants With Development of SARS-CoV-2 Antibodies
Time frame: Up to 28 days
Time Until Cessation of Symptoms
Time frame: Up to 28 days
Count of Participant With Absence of Development of Any Symptoms
Time frame: Up to 28 days
Cmax of Favipiravir
Time frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
Cmin of Favipiravir
Time frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35446944Holubar M, Subramanian A, Purington N, Hedlin H, Bunning B, Walter KS, Bonilla H, Boumis A, Chen M, Clinton K, Dewhurst L, Epstein C, Jagannathan P, Kaszynski RH, Panu L, Parsonnet J, Ponder EL, Quintero O, Sefton E, Singh U, Soberanis L, Truong H, Andrews JR, Desai M, Khosla C, Maldonado Y. Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Clin Infect Dis. 2022 Nov 30;75(11):1883-1892. doi: 10.1093/cid/ciac312.
- Derived from this study: PubMed 33624010Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
- Individual participant dataSharing planned: No. No current plan to share individual participant data (IPD).
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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.
Yvonne (Bonnie) A Maldonado, MD principal investigator
Stanford 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 Favipiravir in people with Sars-CoV2 and COVID-19, run by Stanford University 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 10 inclusion and 13 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 13 Jul 2022. 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. 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 Apr 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 Until Cessation of Oral Shedding of SARS-CoV-2 Virus (time frame: Up to 28 days). 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 NCT04346628, which also lists 2 linked publications.
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 13 Jul 2022.