Trial · NCT04550936
A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.
NCT04550936, Completed, Pfizer; results first posted 2025-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions. Trials, record NCT04550936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04550936
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.
- NCT number
- NCT04550936
- Status
- Completed
- Enrollment
- 307 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Invasive Aspergillosis, Mucormycosis
- Interventions
- Isavuconazole
- First posted
- 2020-09-16
- Last updated
- 2025-12-09
- Results first posted
- 2025-12-09
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Clinical Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Clinical Response at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Radiological Response at Week 6 | Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (\>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Radiological Response at Week 12 | Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Radiological Response at Week 24 | Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Mycological Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Mycological Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | Number of Participants With Mycological Response at Week 24 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Primary | All-Cause Mortality at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Response at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Radiological Response at Week 6 | Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Radiological Response at Week 12 | Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Radiological Response at Week 24 | Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Mycological Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Mycological Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Mycological Response at Week 24 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All-Cause Mortality at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Analysis population included all eligible participants whose data was retrieved and analyzed in this study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Response at Week 6 | Invasive Aspergillosis | Unknown | 173 | Participants | |
| Number of Participants With Clinical Response at Week 6 | Mucormycosis | Unknown | 14 | Participants | |
| Number of Participants With Clinical Response at Week 6 | Invasive Aspergillosis | Clinical success | 27 | Participants | |
| Number of Participants With Clinical Response at Week 6 | Mucormycosis | Clinical success | 3 | Participants | |
| Number of Participants With Clinical Response at Week 6 | Invasive Aspergillosis | Clinical failure | 1 | Participants | |
| Number of Participants With Clinical Response at Week 6 | Mucormycosis | Clinical failure | 0 | Participants | |
| Number of Participants With Clinical Response at Week 12 | Invasive Aspergillosis | Unknown | 185 | Participants | |
| Number of Participants With Clinical Response at Week 12 | Mucormycosis | Unknown | 15 | Participants | |
| Number of Participants With Clinical Response at Week 12 | Invasive Aspergillosis | Clinical success | 16 | Participants | |
| Number of Participants With Clinical Response at Week 12 | Mucormycosis | Clinical success | 2 | Participants |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Invasive Aspergillosis | 201 | |
| Overall Study | STARTED | Mucormycosis | 17 | |
| Overall Study | COMPLETED | Invasive Aspergillosis | 201 | |
| Overall Study | COMPLETED | Mucormycosis | 17 | |
| Overall Study | NOT COMPLETED | Invasive Aspergillosis | 0 | |
| Overall Study | NOT COMPLETED | Mucormycosis | 0 |
Source ClinicalTrials.gov
Adverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Invasive Aspergillosis | 2 | 201 | |
| other | Diarrhoea | Gastrointestinal disorders | Mucormycosis | 0 | 17 | |
| other | Nausea | Gastrointestinal disorders | Invasive Aspergillosis | 2 | 201 | |
| other | Nausea | Gastrointestinal disorders | Mucormycosis | 0 | 17 | |
| other | Vomiting | Gastrointestinal disorders | Invasive Aspergillosis | 1 | 201 | |
| other | Vomiting | Gastrointestinal disorders | Mucormycosis | 0 | 17 | |
| other | Phlebitis | General disorders | Invasive Aspergillosis | 0 | 201 | |
| other | Phlebitis | General disorders | Mucormycosis | 1 | 17 | |
| other | Peripheral oedema | General disorders | Invasive Aspergillosis | 0 | 201 | |
| other | Peripheral oedema | General disorders | Mucormycosis | 1 | 17 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Invasive Aspergillosis | 127 | 201 |
| Total, all-cause mortality | Mucormycosis | 10 | 17 |
| Total, other adverse events | Invasive Aspergillosis | 17 | 201 |
| Total, other adverse events | Mucormycosis | 2 | 17 |
| Total, serious adverse events | Invasive Aspergillosis | 34 | 201 |
| Total, serious adverse events | Mucormycosis | 3 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39443403 | DERIVED |
Source PubMed
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 comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Adverse Event at Week 24 | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Inpatient Hospitalization | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Adverse Event at Week 12 | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Isavuconazole Administered as Part of Combination Therapy | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: All-Cause Mortality at Week 6 | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Serious Adverse Event at Week 12 | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants Who Switched to New Antifungal | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Adverse Event at Week 6 | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Any Outpatient Visits | Trial comparisons |
| Invasive Aspergillosis vs Mucormycosis: Number of Participants With Serious Adverse Event at Week 6 | Trial comparisons |
1 to 10 of 17
See all 17 trial comparisonsTests0
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/NCT04550936
GET https://conductscience.org/api/trials/v1/NCT04550936/registered?page=2