A clinical trial to observe patients with a diagnosis of COVID-19, who have previously taken part in an AT-527 COVID-19 clinical trial

A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study

  • Infectious Diseases
  • COVID-19 Pneumonia
  • COVID-19
Please note that the recruitment status of the trial at your site may differ.
Trial Status:

Terminated

This trial runs in
Cities
  • Aalborg
  • Ankara
  • București
  • Caracal
  • Ciudad de México
  • Creixomil
  • Distrito Federal
  • el-salitre
  • gesves
  • Guadalajara
  • İstanbul
  • Ivano-Frankivs'k
  • İzmir
  • Kropyvnytskyi
  • Kyiv
  • Köln
  • København
  • Mar del Plata
  • Matosinhos
  • Paraná
  • Pernambuco
  • Roskilde
  • Sibiu
  • São Paulo
  • thuin
  • Torreón
  • Trabzon
  • Vinnytsia
  • Zaporizhzhia
  • Zürich
Trial Identifier:

NCT05059080 2021-000627-12 CV43140

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      NCT05059080,CV43140,2021-000627-12 Trial Identifier
      All Gender
      ≥12 Years Age
      No Healthy Volunteers

      How does the MEADOWSPRING clinical trial work?
      This clinical trial is recruiting people who have previously been diagnosed with COVID-19 and have already taken part in a previous clinical trial of AT-527.

      The purpose of this clinical trial is to understand the long-term effects of COVID-19 on patients, including symptoms, impact on daily life and general health status. The long-term effects of COVID-19 are sometimes described as ‘long COVID’. 

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be at least 12 years old (weighing at least 40 kg) or at least 18 years old (regardless of weight). You must have previously been diagnosed with COVID-19 (either fully recovered or have ongoing COVID-19 symptoms) and have taken part in the phase III AT-527 COVID-19 clinical trial known as MORNINGSKY.

      You must not join, or plan to join, another clinical trial while taking part. If you have a serious medical condition, you may also not be able to take part in this clinical trial.  

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You may have some further tests to make sure you can take part in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial.

      For women, if you become pregnant during this clinical trial, you will need to report this immediately to your clinical trial doctor so that they can discuss the possible risks with you. Pregnancies will be monitored closely during the clinical trial.

      What treatment will I be given if I join this clinical trial?

      You will not be given any investigational treatment during this clinical trial. You will have received treatment with AT-527 or placebo while taking part in the previous MORNINGSKY COVID-19 clinical trial, but the MEADOWSPRING clinical trial will not require you to take any further treatment.

      How often will I be seen in follow-up appointments and for how long?

      You will be observed for roughly six months and will be contacted (sometimes remotely by phone/computer) by your clinical trial doctor every month. Hospital visits or mobile nurse visits may include blood collection, urine collection, swabs of your nose and throat (only if clinically required, this is not routine), and checks of your general health. You will also be asked to complete a COVID-19 ‘symptom diary’ once a week and will regularly complete questionnaires about your health and how you are feeling. You may be given a wearable device (like a smart watch) to monitor your heart rate, oxygen levels, activity and sleep patterns. 

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given, if relevant. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov

      Trial-identifier: NCT05059080 

      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.

      Hoffmann-La Roche Sponsor
      NCT05059080,CV43140,2021-000627-12 Trial Identifier
      COVID-19, Long COVID Condition
      Official Title

      A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study

      Eligibility Criteria

      All Gender
      ≥12 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study
      Exclusion Criteria
      • 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

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