Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obeldesivir · 1 trial · 1 indication
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
TEAEs were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. * Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| Obeldesivir | EXPERIMENTAL | Participants will receive obeldesivir 350 mg twice daily for 5 days. |
| Obeldesivir Placebo | PLACEBO_COMPARATOR | Participants will receive obeldesivir placebo twice daily for 5 days. |
| Name | Type | Description |
|---|---|---|
| Obeldesivir | DRUG | Tablet administered orally without regard to food. |
| Obeldesivir Placebo | DRUG | Tablet administered orally without regard to food. |
Key Inclusion Criteria: * Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted. * Willing and able to complete t...
Obeldesivir is an investigational small molecule being studied for the treatment of COVID-19. It is being developed by Gilead Sciences, Inc. for use in nonhospitalized patients with the infection.
Obeldesivir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
Obeldesivir is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed.
Obeldesivir has one completed Phase 3 clinical trial, identified as NCT05715528, titled 'Study of Obeldesivir in Nonhospitalized Participants With COVID-19'. The trial enrolled 2,011 participants in the United States and Japan.
Obeldesivir is not FDA approved. It is an investigational drug currently in clinical development. A Phase 3 trial has been completed, but approval status has not been established.