COVID-19MEADOWSPRINGNCT05059080
A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study
An observational study of COVID-19 and Long COVID, run by Hoffmann-La Roche at 35 sites in 10 countries.
Trial summary
This study will evaluate the long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]), for approximately 6 months after the end of the parent study. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19, Long COVID
- How many people
- 72 participants
- Where
- 35 sitesin 10 countries
- Study dates
- 15 Jun 2021to 16 Mar 2022
- Phase
- Observational
- 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
Study population: Participants enrolled in a RO7496998 (AT-527) study.
Who may be able to join
- Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study
Who cannot join
- Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study.
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
Ukraine8 sites
CNPE City Clinical Hospital #6 of DCC
Dnipro, Kholm Governorate, 49074
Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, Katerynoslav Governorate, 76025
Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
Kharkiv, Kharkiv Governorate, 61124
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
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
L2IP -Instituto de Pesquisas Clínicas Ltda.
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)5 sites
Gazi Universitesi Tip Fakultesi
Ankara, 06100
Hacettepe University Medical Faculty
Ankara, 06100
Ankara University Medical Faculty - PPDS
Çankaya, 06590
Ege University Medical Faculty
Izmir, 35100
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080
Denmark3 sites
Aalborg Universitetshospital
Aalborg, 9000
Rigshospitalet Copenhagen University Hospital
Copenhagen, DK-2100
Sjællands Universitetshospital, Roskilde
Roskilde, 4000
Romania3 sites
Prof. Dr. Matei Bals Institute of Infectious Diseases
Bucharest, 021105
County Hospital Caracal
Caracal, 235200
Sibiu Emergency Clinical County Hospital
Sibiu, 550245
Belgium2 sites
Private Practice Dr Jean Benoit Martinot
Erpent, 5101
Medif
Gozée, 6534
About this study
Official title: A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
This study will evaluate the long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]), for approximately 6 months after the end of the parent study.
- Conditions
- COVID-19, Long COVID
- Keywords
- Coronavirus Disease 2019, COVID-19, SARS-CoV-2, Mild to Moderate COVID-19, Long-COVID, Observational
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Diagnosed with COVID-19 | Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
COVID-19 symptoms were evaluated using the COVID-19 Symptom Diary. The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 were recorded on a 4-point Likert scale (i.e none/mild/moderate/severe). Items 13-14 were recorded on a 3-point Likert scale (i.e. same as usual/less than usual/no sense). Reported here is the percentage of participants with COVID-19 symptoms (mild/moderate/severe or less than usual/no sense) recorded during week 4 of each month following the baseline assessment.
Measured: Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
Secondary outcomes (8)
Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
The PROMIS-SF-Dyspnea Questionnaire is a 10-item questionnaire to evaluate the impact of dyspnea on specific activities. Participants self-assessed the severity of shortness of breath and difficulty of breathing in response to specific activities with a recall of the past 7 days. The PROMIS SF-Dyspnea Severity instrument is scored on a 4-point Likert scale, with an option to indicate that an activity had not been performed. Total score range is 0-30, where a higher score indicates a higher symptom severity of dyspnea.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a 50-item respiratory-specific health-related quality of life instrument that measures health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. Each scale is scored from 0 to 100, and the total score represents the weighted average of these three subscores. Higher scores correspond to worse quality of life. The SGRQ had a recall specification of 4 weeks.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Percentage of Participants With COVID-19 Related Medically-Attended Visits
COVID-19-related medically-attended visits were defined as hospitalization, ER visit, urgent care visit, physician's office visit, or telemedicine visit with the primary reason for the visit being COVID-19 or COVID-19-related symptoms.
Measured: Up to 6 months
Percentage of Participants With Death Attributable to Progression of COVID-19
Measured: Up to 6 months
Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Reinfection was defined as any nasopharyngeal (NP) swab that was positive for SARS-CoV-2 infection via reverse-transcriptase polymerase chain reaction (RT-PCR), taken when clinically indicated based on symptoms.
Measured: Up to 6 months
Percentage of Participants With Any Post-Treatment Infection
Post-treatment infections were defined as any adverse event with a primary system organ class of infections and infestations.
Measured: Up to 6 months
Percentage of Participants With COVID-19-Related Complications
COVID-19 related complications included pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis and/or myocarditis, and cardiac failure.
Measured: Up to 6 months
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Jun 2021
- Primary completion7 Mar 2022
- Study completion16 Mar 2022
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 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
- NCT05059080
- Sponsor's protocol ID
- CV43140
- Other IDs
- 2021-000627-12
- Acronym
- MEADOWSPRING
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2021
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
- ClinicalTrials.gov ID
- NCT05059080
- Acronym / sponsor ID
- MEADOWSPRING / CV43140
- Conditions
- COVID-19, Long COVID
- Keywords
- Coronavirus Disease 2019, COVID-19, SARS-CoV-2, Mild to Moderate COVID-19, Long-COVID, Observational
- Study type
- Observational
- 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
- 72 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Atea Pharmaceuticals, Inc.
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 28 Jul 2023
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 long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]), for approximately 6 months after the end of the parent study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Diagnosed with COVID-19 | – | –Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants enrolled in a RO7496998 (AT-527) study.
Key inclusion criteria (1 listed)
- Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study
Key exclusion criteria (2 listed)
- Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study.
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
Time frame: Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
COVID-19 symptoms were evaluated using the COVID-19 Symptom Diary. The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 were recorded on a 4-point Likert scale (i.e none/mild/moderate/severe). Items 13-14 were recorded on a 3-point Likert scale (i.e. same as usual/less than usual/no sense). Reported here is the percentage of participants with COVID-19 symptoms (mild/moderate/severe or less than usual/no sense) recorded during week 4 of each month following the baseline assessment.
8 secondary outcomes
Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Percentage of Participants With COVID-19 Related Medically-Attended Visits
Time frame: Up to 6 months
Percentage of Participants With Death Attributable to Progression of COVID-19
Time frame: Up to 6 months
Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Time frame: Up to 6 months
Percentage of Participants With Any Post-Treatment Infection
Time frame: Up to 6 months
Percentage of Participants With COVID-19-Related Complications
Time frame: Up to 6 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Long COVID, run by Hoffmann-La Roche at 35 sites in 10 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 1 inclusion and 2 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Ukraine, Mexico, Brazil, Turkey (Türkiye), Denmark and 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). 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?
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6 (time frame: Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4). 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 28 Jul 2023.