Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
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|ClinicalTrials.gov Identifier: NCT04709835|
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: AT-527 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Otherwise Healthy Non-Hospitalized Adult Patients With Mild or Moderate COVID-19|
|Estimated Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||February 15, 2021|
|Estimated Study Completion Date :||February 15, 2021|
Participants will receive 550 mg AT-527 twice a day (BID) on an outpatient basis in Cohort A. Cohorts B-E doses are to be determined.
Results from Cohort A will determine the dose and regimen to be used for Cohort B. Cohort C, D and E dose and regimen will also be based on emerging data.
Other Name: RO7496998
|Placebo Comparator: Placebo||
The dose and regimen of the placebo will match that of the respective AT-527 comparator arm.
- Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 14. ]SARS-CoV-2 virus RNA will be measured by reverse-transcription polymerase chain reaction (RT-PCR).
- Time to Cessation of SARS-CoV-2 Viral Shedding [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 14. ]Time to cessation of viral shedding is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.
- Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 14. ]Time to sustained non-detectable SARS-CoV-2 virus RNA is defined as the time from initiation of study treatment to the last timepoint when the virus RNA by RT-PCR is below the limit of detection.
- Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 14. ]
- Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 14. ]AUC in the amount of SARS-CoV-2 virus RNA from baseline to the last sample timepoint.
- Time to Alleviation of COVID-19 Symptoms [ Time Frame: Up to 28 Days ]Alleviation of symptoms is defined as the length of time taken from start of treatment to the point at which the following criteria are met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
- Duration of Fever [ Time Frame: Up to 28 Days ]Defined as the time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours
- Frequency of COVID-19 Related Complications [ Time Frame: Up to 33 Days ]Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis, and cardiac failure.
- Time to Alleviation of an Individual Symptom [ Time Frame: Up to 28 Days ]
Time to alleviation of an individual symptom is defined as the time taken from the start of treatment 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 1-12 of the COVID-19 Symptom Diary.
- Score of 0 for Items 13 and 14 of the COVID-19 Symptom Diary.
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 33 Days ]
- Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 8 ]AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT 273.
- Relationship Between Plasma Concentration of AT- 273 and Anti-Viral Activity [ Time Frame: Cohort A: Up to Day 7; Cohorts B-E: Up to Day 8 ]Drug exposure response relationship will be explored through modelling (PK-PD modelling) to evaluate the relationship between plasma concentrations of AT-273 and viral load at each timepoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709835
|Contact: WV43042 firstname.lastname@example.org|
|Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC|
|Gabrovo, Bulgaria, 5300|
|MHAT Dr. Atanas Dafovski AD|
|Kardzhali, Bulgaria, 6600|
|Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD|
|Lovech, Bulgaria, 5500|
|Multiprofile Hospital for Active Treatment Plovdiv|
|Plovdiv, Bulgaria, 4003|
|Multiprofile Hospital for Active Treatment (MHAT) - Targovishte|
|Targovishte, Bulgaria, 7700|
|Dublin, Ireland, 15|
|Tower Family Healthcare - Moorgate Primary Care Ce|
|Bury, United Kingdom, BL9 0NJ|
|Study Director:||Clinical Trials||Hoffmann-La Roche|