Trial · NCT04501783
Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
NCT04501783, Phase 3, Completed, R-Pharm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19. Trials, record NCT04501783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04501783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
- NCT number
- NCT04501783
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- R-Pharm
- Conditions
- COVID-19
- Interventions
- Favipiravir, Standard of care (SOC), standard concomitant therapy
- First posted
- 2020-08-06
- Last updated
- 2023-01-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to clinical improvement | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening |
| Primary | Time to viral clearance | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling |
| Secondary | Rate of clinical improvement at separate time points | Day 7 | To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement |
| Secondary | Rate of viral clearance at separate time points | Days 5 and 7 | To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points |
| Secondary | Time to body temperature normalization | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature \< 37°C without antipyretics for at least 48 hours. |
| Secondary | Rate of resolution of lung changes on CT | Day 14 | To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT |
| Secondary | Rate of adverse drug reactions (ADR) and serious ADR | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR |
| Secondary | Rate of severe ADR | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR |
| Secondary | Rate therapy termination due to ADR | through Day 28 | To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04501783
GET https://conductscience.org/api/trials/v1/NCT04501783/registered