Trial · NCT05894603
Effectiveness and Safety of New Oral Antivirals for COVID-19
NCT05894603, Unknown, Universidade do Porto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness and Safety of New Oral Antivirals for COVID-19. Trials, record NCT05894603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05894603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness and Safety of New Oral Antivirals for COVID-19
- NCT number
- NCT05894603
- Status
- Unknown
- Enrollment
- 211 participants, actual
- Lead sponsor
- Universidade do Porto
- Conditions
- COVID-19
- Interventions
- Nirmatrelvir/ritonavir, Molnupiravir
- First posted
- 2023-06-08
- Last updated
- 2023-12-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety outcome | 6 days after onset treatment for both drugs. | The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked. |
| Primary | Safety outcome | 39 days after treatment onset for nirmatrelvir/ritonavir cohort. | The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked. |
| Primary | Safety outcome | 19 days after treatment onset for molnupiravir cohort. | The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked. |
| Primary | Effectiveness outcome | 29 days after treatment onset for both drugs. | The incidence of hospitalisation for any cause (defined as ≥24 hours of acute care in a hospital or any similar facility) or death for any cause through day 29. |
| Secondary | Adherence to treatment | 6 days after onset treatment for both drugs. | Will be measured using the self-reported 7-item Measure Treatment Adherence (MTA) tool validated for the Portuguese Population. The MTA is a psychometric tool derived from the Morisky et al. questionnaire and evaluates the individuals' behaviour concerning the daily use of medication. |
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/NCT05894603
GET https://conductscience.org/api/trials/v1/NCT05894603/registered