Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Favipiravir · 1 trial · 1 indication
The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
| Arm | Type | Description |
|---|---|---|
| Favipiravir | EXPERIMENTAL | Favipiravir 200mg tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo 200mg tablet |
| Name | Type | Description |
|---|---|---|
| Favipiravir | DRUG | Favipiravir |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Adults age 18 or older * Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample (either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR tracheobronchial aspirate OR saliva) collected within 72 hours of randomization * Stated willingness ...
Favipiravir is an investigational small molecule being studied for the treatment of Covid-19. It is currently in Phase 3 clinical development, with a completed trial evaluating its efficacy and safety in preventing severe Covid-19. The drug is not yet approved and remains under investigation.
Favipiravir is a small molecule antiviral that targets the RNA-dependent RNA polymerase of viruses, inhibiting viral replication. This mechanism is being studied in the context of Covid-19, where it aims to reduce viral load and prevent disease progression.
Favipiravir is being developed by Aditxt, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ADTX. The company is conducting clinical trials to evaluate the drug's potential in treating Covid-19.
Favipiravir is in Phase 3 clinical development for Covid-19. A Phase 3 trial has been completed, but the drug remains investigational and has not received regulatory approval. Further development may be required before it can be considered for approval.
Favipiravir has one completed Phase 3 clinical trial, identified as NCT04600895, titled "The Prevent Severe COVID-19 (PRESECO) Study." This randomized, double-blind, placebo-controlled trial enrolled 1,187 participants across the United States, Brazil, and Mexico, and included adults aged 18 years and older.
Favipiravir is a distinct small molecule antiviral with its own mechanism of action, targeting viral RNA polymerase. It is not the same as other antiviral drugs, though it belongs to a class of medications that inhibit viral replication. Its specific profile is being studied for Covid-19.