COVID-19Phase 3MORNINGSKYNCT04889040
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
A Phase 3 study testing RO7496998 in people with COVID-19, run by Hoffmann-La Roche at 50 sites in 12 countries.
Trial summary
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- RO7496998
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 50 sitesin 12 countries
- Study dates
- 28 Apr 2021to 2 Dec 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
- At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
- Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1
Who cannot join
- Clinical signs indicative of COVID-19 illness requiring hospitalization
- Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
- In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
- Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
- Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
- Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
Show all 12Show fewer
- Known allergy or hypersensitivity to components of study drug
- Abnormal laboratory test results at screening
- Requirement of any prohibited medications during the study
- Other known active viral or bacterial infection at the time of screening, such as influenza
- Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
- COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
Trial locations and contacts
50 sites in 12 countries.
50 sites in 12 countries
Japan13 sites
Higashiosaka city Medical Center
Higashiosaka-Shi, 578-0947
Rinku General Medical Center
Izumisano, 598-0048
Sagamihara Kyodo Hospital
Kanagawa, 252-5188
Misyuku hospital
Meguro-Ku, 153-0051
IUHW Narita Hospital
Narita, 286-8520
Houjin Syadan Kouhoukai Takagi Hospital
Okawa-Shi, 831-0016
Okayama City Hospital
Okayama, 700-8557
Ome Municipal General Hospital
Ome-Shi, 198-0042
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Shinagawa City, 140-8522
Edogawa Medicare Hospital
Tokyo, 133-0071
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-0052
Tokyo Medical University Hachioji Medical Center
Tokyo, 193-0998
Ukraine9 sites
CNPE City Clinical Hospital #6 of DCC
Dnipro, Kholm Governorate, 49074
Municipal Non-profit Enterprise ?City Clinical Hospital #13? of Kharkiv City Council
Kharkiv, Kharkiv Governorate, 61124
Public Non-Profit Enterprise ?City Outpatient Clinic #9? of Kharkiv City Council
Kharkiv, Kharkiv Governorate, 61172
Medical Center LLC "Harmony of Beauty"
Kyiv, KIEV Governorate, 01135
CNE Kyiv City Clinical Hospital#1 of Exec. Body
Kyiv, KIEV Governorate, 02091
Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
Kyiv, KIEV Governorate, 03049
Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem
Kyiv, KIEV Governorate, 04050
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia, Podolia Governorate
Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council
Zaporizhzhya, Tavria Okruha, 69118
Mexico6 sites
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco, 44670
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, 44100
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), 06700
PanAmerican Clinical Research, Querétaro
Queréaro, Querétaro, 76230
CIMAB SA de CV
Torreón, Coahuila, 27000
Brazil5 sites
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
Brasília, Federal District, 70200-730
Hospital Nossa Senhora das Graças
Curitiba, Paraná, 80810-040
Hospital Agamenon Magalhães
Recife, Pernambuco, 52051-380
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, 02401-400
Chronos Pesquisa Clinica
Taguatinga, Federal District, 72145-450
Turkey (Türkiye)4 sites
Gazi Universitesi Tip Fakultesi
Ankara, 06100
Ankara University Medical Faculty - PPDS
Çankaya, 06590
Ege University Medical Faculty
Izmir, 35100
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080
Belgium3 sites
Maison Médicale La Brèche
Châtelineau, 6200
Private Practice Dr Jean Benoit Martinot
Erpent, 5101
Medif
Gozée, 6534
Romania3 sites
Prof. Dr. Matei Bals Institute of Infectious Diseases
Bucharest, 021105
County Hospital Caracal
Caracal, 235200
Sibiu Emergency Clinical County Hospital
Sibiu, 550245
Denmark2 sites
Aalborg Universitetshospital
Aalborg, 9000
Rigshospitalet Copenhagen University Hospital
Copenhagen, DK-2100
Switzerland2 sites
Hôpital Universitaire de Genève (HUG)
Geneva, 1211
Universitätsspital Zürich
Zurich, 8091
Portugal1 site
Unidade Local de Saude de Matosinhos SA
Matosinhos Municipality, 4454-509
About this study
Official title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.
- Conditions
- COVID-19
- Being tested
- RO7496998, Placebo
- Keywords
- Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7496998Drug
Also called AT-527
275 mg tablets
PlaceboDrug
Matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The dose and regimen of the placebo will match that of AT-527. Receives: Drug: Placebo |
| RO7496998 (AT-527) | Experimental | Orally administered, 550 mg twice daily (BID) for 5 days Receives: Drug: RO7496998 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe).
The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.
Measured: Up to 29 days
Secondary outcomes (19)
Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe).
The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 43 hours.
Measured: Up to 29 days
Time to Alleviation of COVID-19 Symptoms (21.5 Hours)
Time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours.
- Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Measured: Up to 29 days
Time to Alleviation of COVID-19 Symptoms (43 Hours)
Time from randomization to the point at which the following criterion is met and maintained for at least 43 hours.
- Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Measured: Up to 29 days
Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms
Time from randomization to the point at which symptoms (Items 1-12 of the COVID-19 Symptom Diary) have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale, maintained for at least 21.5 hours.
Measured: Up to 29 days
Time to Alleviation of Individual Symptoms
Time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours.
- Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary
Measured: Up to 29 days
Percentage of Participants Requiring Hospitalization for COVID-19
Hospitalizations for COVID-19 are defined as SAEs for which the investigator has cited that the suspected cause was the disease under study and where there is a non-missing hospital admission date.
Measured: Up to Day 33 visit
Percentage of Participants With Greater Than or Equal to 1 COVID-19 Related Medically Attended Visit
Medically attended visit is defined as hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19.
Measured: Up to Day 33 visit
Duration of Fever
Time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours.
Measured: Up to 29 days
Percentage of Participants With COVID-19 Related Complications
COVID-related complications are defined as death, hospitalization, pneumonia, sepsis, coagulopathy, pericarditis/myocarditis and cardiac failure.
Pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, and cardiac failure were adjudicated per blinded manual medical review of events by an internal adjudication team before study readout.
Measured: Up to Day 33 visit
Percentage of Participants With Any Post-Treatment Infection
Post-treatment infections were defined as any treatment-emergent adverse event with a primary system organ class of infections and infestations.
Measured: Up to Day 33 visit
Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA
SARS-CoV-2 virus RNA will be measured by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR)
Measured: Baseline and on Days 3, 5, 7 and 14
Time to Cessation of SARS-CoV-2 Viral Shedding
Defined as time from randomization to the first time when a negative qualitative virus RNA by RT-PCR test result is obtained.
Measured: Up to 14 days
Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
Defined as percentage of participants with a positive qualitative virus RNA by RT-PCR.
Measured: Baseline and on Days 3, 5, 7 and 14
Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
Measured: Day 1 prior to dosing, Day 3, Day 5, Day 7 and Day 14
Percentage of Participants With Adverse Events (AEs)
Measured: Up to Day 33 visit
Plasma Concentration of AT-511 at Specified Timepoints
AT-511 is the free base form of RO7496998 (AT-527).
Measured: Up to 7 days
Plasma Concentration of AT-551 at Specified Timepoints
AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010)
Measured: Up to 7 days
Plasma Concentration of AT-229 at Specified Timepoints
AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010)
Measured: Up to 7 days
Plasma Concentration of AT-273 at Specified Timepoints
AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010)
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start28 Apr 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Why it stopped: Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
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 COVID-19Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atea Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889040
- Sponsor's protocol ID
- CV43043
- Other IDs
- 2020-005759-18
- Acronym
- MORNINGSKY
- Status last verified
- Mar 2023
- First submitted
- 10 May 2021
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm)
Publications
Horga A, Saenz R, Yilmaz G, Simon-Campos A, Pietropaolo K, Stubbings WJ, Collinson N, Ishak L, Zrinscak B, Belanger B, Granier C, Lin K, C Hurt A, Zhou XJ, Wildum S, Hammond J. Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY). Future Virol. 2023 Oct:10.2217/fvl-2023-0115. doi: 10.2217/fvl-2023-0115. Epub 2023 Nov 1.
PubMed 37928891
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04889040
- Acronym / sponsor ID
- MORNINGSKY / CV43043
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Atea Pharmaceuticals, Inc.
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe dose and regimen of the placebo will match that of AT-527. |
| RO7496998 (AT-527) | Experimental | Drug: RO7496998Orally administered, 550 mg twice daily (BID) for 5 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
- At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
- Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1
Key exclusion criteria (12 listed)
- Clinical signs indicative of COVID-19 illness requiring hospitalization
- Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
- In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
- Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
- Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
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 |
|---|---|---|
| RO7496998Also: AT-527275 mg tablets | Drug | RO7496998 (AT-527) |
| PlaceboMatching tablets | Drug | Placebo |
Primary outcome
Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
Time frame: Up to 29 days
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.
19 secondary outcomes
Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)
Time frame: Up to 29 days
Time to Alleviation of COVID-19 Symptoms (21.5 Hours)
Time frame: Up to 29 days
Time to Alleviation of COVID-19 Symptoms (43 Hours)
Time frame: Up to 29 days
Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms
Time frame: Up to 29 days
Time to Alleviation of Individual Symptoms
Time frame: Up to 29 days
Percentage of Participants Requiring Hospitalization for COVID-19
Time frame: Up to Day 33 visit
Percentage of Participants With Greater Than or Equal to 1 COVID-19 Related Medically Attended Visit
Time frame: Up to Day 33 visit
Duration of Fever
Time frame: Up to 29 days
Percentage of Participants With COVID-19 Related Complications
Time frame: Up to Day 33 visit
Percentage of Participants With Any Post-Treatment Infection
Time frame: Up to Day 33 visit
Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA
Time frame: Baseline and on Days 3, 5, 7 and 14
Time to Cessation of SARS-CoV-2 Viral Shedding
Time frame: Up to 14 days
Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
Time frame: Baseline and on Days 3, 5, 7 and 14
Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
Time frame: Day 1 prior to dosing, Day 3, Day 5, Day 7 and Day 14
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to Day 33 visit
Plasma Concentration of AT-511 at Specified Timepoints
Time frame: Up to 7 days
Plasma Concentration of AT-551 at Specified Timepoints
Time frame: Up to 7 days
Plasma Concentration of AT-229 at Specified Timepoints
Time frame: Up to 7 days
Plasma Concentration of AT-273 at Specified Timepoints
Time frame: Up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37928891Horga A, Saenz R, Yilmaz G, Simon-Campos A, Pietropaolo K, Stubbings WJ, Collinson N, Ishak L, Zrinscak B, Belanger B, Granier C, Lin K, C Hurt A, Zhou XJ, Wildum S, Hammond J. Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY). Future Virol. 2023 Oct:10.2217/fvl-2023-0115. doi: 10.2217/fvl-2023-0115. Epub 2023 Nov 1.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
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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.
Clinical Trials study director
Hoffmann-La Roche
50 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RO7496998 in people with COVID-19, run by Hoffmann-La Roche at 50 sites in 12 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Japan, Ukraine, Mexico, Brazil, Turkey (Türkiye) and 7 more countries. 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 5 Jan 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?
Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours) (time frame: Up to 29 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 NCT04889040, 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 5 Jan 2024.