Covid19Phase 3PRESECONCT04600895
The Prevent Severe COVID-19 (PRESECO) Study
A Phase 3 study testing Favipiravir in people with Covid19, run by Appili Therapeutics Inc. at 38 sites in 3 countries.
Trial summary
Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- 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
- 1,187 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 30 Nov 2020to 20 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 or older
- Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample (either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR tracheobronchial aspirate OR saliva) collected within 72 hours of randomization
- Stated willingness to give their written informed consent to participate in the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for 7 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
Show all 23Show fewer
- 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
- Ability to take oral medication and be willing to adhere to the favipiravir/placebo regimen
- Subject has access to a smart phone, tablet, or PC
- Minimal baseline severity score for COVID-19-related symptoms: at least two symptoms with a score of 2 or higher. COVID-19-related symptoms (excluding changes in the sense of taste or smell) include:
- stuffy or runny nose
- sore throat
- shortness of breath
- cough
- lack of energy or tiredness
- muscle or body aches
- headache
- chills or shivering
- feeling hot or feverish
- nausea
- diarrhea
- vomiting
Who cannot join
- O2 saturation <94%
- Shortness of breath at rest
- Heart rate ≥ 125 per minute
- COVID-19 symptoms first presented >5 days prior to randomization
- Requirement for hospitalization at the time of enrollment
- Participation in another trial or use of any experimental treatment for COVID-19
Show all 19Show fewer
- Treatment with high steroid dose i.e. >30 mg/day prednisolone equivalent (excluding stable chronic treatment) or remdesivir or anyone receiving SARS-CoV-2 monoclonal antibodies within 3 months prior to enrollment
- Known sepsis or organ dysfunction/ failure
- Known infection with a respiratory virus other than SARS-CoV2 (e.g. Influenza) or any known bacterial infection (affecting the respiratory system or any other system)
- Inability to adhere to study requirements
- For premenopausal women: unwilling or unable to use effective birth control measures
- Known allergy to favipiravir
- Known end-stage kidney disease or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
- Known liver impairment greater than Child-Pugh A
- Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
- Known elevated uric acid levels in the past year or taking uric acid lowering medications (allopurinol, febuxostat)
- History of hereditary xanthinuria or history of xanthine urolithiasis.
- History of gout or actively being treated for gout.
- Current use of the following medications, which cannot be discontinued for the duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen per day.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States25 sites
Xera Med Research
Boca Raton, Florida, 33487
Synergy Healthcare
Bradenton, Florida, 34208
Best Quality Research,Inc.
Hialeah, Florida, 33016
Elixia Clinical Research Collaborative
Hollywood, Florida, 33023
Next Level Urgent Care
Houston, Texas, 77057
Clinical Trial Network
Houston, Texas, 77074
Frontier Clinical Research
Kingwood, West Virginia, 26537
New Phase Research & Development
Knoxville, Tennessee, 37909
B.G Clinical Research Center, LLC
Little Rock, Arkansas, 72205
Homestead Associates In Research
Miami, Florida, 33032
Verus Clinical Research Corporation
Miami, Florida, 33125
Quality Professional HealthCare
Miami, Florida, 33126
Continental Clinical Research, LLC
Miami, Florida, 33144
Global Life Research Network, Llc
Miami, Florida, 33155
Sanitas Research, LLC
Miami, Florida, 33155
US Associates in Research, LLC
Miami, Florida, 33175
Cahaba Research, Inc.
Pelham, Alabama, 35124
Biore'Search Institute Llc
Pembroke Pines, Florida, 33026
Luminous Clinical Research - South Florida Urgent Care
Pembroke Pines, Florida, 33029
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Absolute Clinical Research
Phoenix, Arizona, 85051
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
University of Massachusettts Medical School
Worcester, Massachusetts, 01655
Brazil7 sites
Centro de Pesquisas Clínicas de Natal
Natal, Rio Grande do Norte
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
LMK Servicos Medicos S/S
Porto Alegre, Rio Grande do Sul
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Pesquisare Saude S/S LTDA
Santo André, São Paulo
Centro Medico Mazzei
São Paulo
Hospital Santa Paula
São Paulo
Mexico6 sites
JM Research SC
Cuernavaca, Morelos
Invesclinic Mx
Irapuato, Guanajuato
Panamerican Clinical Research Mexico, S.A. de C. V.
Juriquilla, Querétaro
Tecsi S.C.
Monterrey, Nuevo León
Centro Medico Espiritu Santo
Tequisquiapan, Querétaro
Kohler & Milstein Research S.A. de C.V
Yucatán, Merida
About this study
Official title: Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection
Read the detailed description
COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral replication is expected to be impactful early in the course of disease. The ability to mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can save many lives. Early treatment could also reduce viral shedding, diminishing the period of infectivity and decreasing the number of secondary cases.
- Conditions
- Covid19
- Being tested
- Favipiravir, Placebo
- 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
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir | Experimental | Favipiravir 200mg tablet Receives: Drug: Favipiravir |
| Placebo | Placebo comparator | Placebo 200mg tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Clinical Recovery
The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
Measured: From Day 0 to Day 28
Secondary outcomes (1)
Proportion of Subjects With COVID-19 Progression (Narrow Progression)
Proportion of subjects with COVID-19 progression, where progression is defined as the occurrence from study day 3 onward of any emergency department (ED) visit for COVID-19 worsening or shortness of breath OR hospitalization for COVID-19 worsening or shortness of breath OR death (narrow progression)
Measured: From study day 3 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start30 Nov 2020
- Primary completion20 Oct 2021
- Study completion20 Oct 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 (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appili Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600895
- Sponsor's protocol ID
- ATI0220
- Acronym
- PRESECO
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2020
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Golan Y, Campos JAS, Woolson R, Cilla D, Hanabergh R, Gonzales-Rojas Y, Lopez R, Finberg R, Balboni A. Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e10-e17. doi: 10.1093/cid/ciac712.
PubMed 36065065
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
- ClinicalTrials.gov ID
- NCT04600895
- Acronym / sponsor ID
- PRESECO / ATI0220
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,187 participants (actual)
- Lead sponsor
- Appili Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection
Detailed description
COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral replication is expected to be impactful early in the course of disease. The ability to mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can save many lives. Early treatment could also reduce viral shedding, diminishing the period of infectivity and decreasing the number of secondary cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir | Experimental | Drug: FavipiravirFavipiravir 200mg tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 200mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Adults age 18 or older
- Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample (either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR tracheobronchial aspirate OR saliva) collected within 72 hours of randomization
- Stated willingness to give their written informed consent to participate in the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for 7 days following the last dose of study medication
Key exclusion criteria (19 listed)
- O2 saturation <94%
- Shortness of breath at rest
- Heart rate ≥ 125 per minute
- COVID-19 symptoms first presented >5 days prior to randomization
- Requirement for hospitalization at the time of enrollment
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 | Drug | Favipiravir |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Sustained Clinical Recovery
Time frame: From Day 0 to Day 28
The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
1 secondary outcome
Proportion of Subjects With COVID-19 Progression (Narrow Progression)
Time frame: From study day 3 to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36065065Golan Y, Campos JAS, Woolson R, Cilla D, Hanabergh R, Gonzales-Rojas Y, Lopez R, Finberg R, Balboni A. Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e10-e17. doi: 10.1093/cid/ciac712.
Related trials for Covid19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
38 sites in 3 countries: 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 Covid19, run by Appili Therapeutics Inc. at 38 sites in 3 countries.
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 23 inclusion and 19 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Brazil, Mexico. 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. Some participants in this study may receive a placebo. 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 29 Mar 2024). 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?
Number of Participants With Sustained Clinical Recovery (time frame: From Day 0 to Day 28). 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 NCT04600895, 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 2024.