Trial · NCT04354428
Treatment for COVID-19 in High-Risk Adult Outpatients
NCT04354428, Phase 2, Phase 3, Terminated, University of Washington; results first posted 2022-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment for COVID-19 in High-Risk Adult Outpatients. Trials, record NCT04354428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04354428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment for COVID-19 in High-Risk Adult Outpatients
- NCT number
- NCT04354428
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 289 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- COVID-19, SARS-CoV-2
- Interventions
- Ascorbic Acid, Hydroxychloroquine Sulfate, Azithromycin, Folic Acid, Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]
- First posted
- 2020-04-21
- Last updated
- 2022-08-08
- Results first posted
- 2022-08-08
- Limitations and caveats
- Early termination of HCQ and HCQ/AZ arms as well as lopinavir-ritonavir arms leading to small numbers of participants analyzed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | 28 days from enrolment | Resting blood oxygen saturation (SpO2\<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough |
| Primary | Number of Participants With Hospitalization or Mortality | Day 28 after enrolment | Number of participants with hospitalization or mortality |
| Primary | Time to Clearance of Nasal SARS-CoV-2 | Day 1 through Day 14 after enrolment | Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs |
| Primary | Time to Resolution of COVID-19 Symptom Resolution in Days | Day 1 through Day 14 after enrolment | COVID-19 symptoms are based on the following criteria: * At least TWO of the following symptoms: Fever (≥ 38ºC), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR * At least ONE of the following symptoms: cough, shortness of breath or difficulty breathing, OR * Severe respiratory illness with at least 1 of the following: * Clinical or radiological evidence of pneumonia, OR * Acute respiratory distress syndrome (ARDS), OR * LRTI, defined by resting SpO2\<93% sustained for 2 readings 2 hours apart AND presence of subjective dyspnea or cough Death or COVID-19-related hospitalizations will count as a failure to resolve symptoms. |
| Secondary | Number of Participants With Serious Adverse Events and Adverse Events Resulting in Treatment Discontinuation | 28 days from enrolment | Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation |
| Secondary | COVID-19-related Hospitalization Days | 28 days from enrolment | Duration of hospitalization among persons who become hospitalized with COVID-19 disease |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | 28 days from enrolment | This outcome was analyzed in the first arm of the platform trial (Ascorbic Acid/Folic Acid HCQ, HCQ/AZ) among the high risk cohort only. The mITT cohort included only those without LRTI at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hospitalization or Mortality | Day 28 after enrolment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Time to Clearance of Nasal SARS-CoV-2 | Day 1 through Day 14 after enrolment | Included the mITT viral shedding cohort, which includes the mITT cohort participants who do not meet the definition for clearance of viral shedding at baseline (day 1 and 2 swabs negative). | Days | MEDIAN |
| PRIMARY | Time to Resolution of COVID-19 Symptom Resolution in Days | Day 1 through Day 14 after enrolment | mITT Disease Resolution cohort includes participants who meet the COVID-19 disease criteria on day 1. The symptom resolution rate was the primary outcome of the lopinavir-ritonavir adaptive platform arms (lopinavir-ritonavir and ascorbic acid). | Days | MEDIAN |
| SECONDARY | Number of Participants With Serious Adverse Events and Adverse Events Resulting in Treatment Discontinuation | 28 days from enrolment | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | COVID-19-related Hospitalization Days | 28 days from enrolment | Days | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | Ascorbic Acid and Folic Acid | 2 | Participants | ||
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | Hydroxychloroquine and Folic Acid | 0 | Participants | ||
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | Hydroxychloroquine and Azithromycin | 4 | Participants | ||
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | Lopinavir-ritonavir | 2 | Participants | ||
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough | Ascorbic Acid | 1 | Participants | ||
| Number of Participants With Hospitalization or Mortality | Ascorbic Acid and Folic Acid | 4 | Participants | ||
| Number of Participants With Hospitalization or Mortality | Hydroxychloroquine and Folic Acid | 2 | Participants | ||
| Number of Participants With Hospitalization or Mortality | Hydroxychloroquine and Azithromycin | 3 | Participants | ||
| Number of Participants With Hospitalization or Mortality | Lopinavir-ritonavir | 0 | Participants | ||
| Number of Participants With Hospitalization or Mortality | Ascorbic Acid | 1 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ascorbic Acid and Folic Acid | 83 | |
| Overall Study | STARTED | Hydroxychloroquine and Folic Acid | 71 | |
| Overall Study | STARTED | Hydroxychloroquine and Azithromycin | 77 | |
| Overall Study | STARTED | Lopinavir-ritonavir | 29 | |
| Overall Study | STARTED | Ascorbic Acid | 29 | |
| Overall Study | Completed Enrollment | Ascorbic Acid and Folic Acid | 80 | |
| Overall Study | Completed Enrollment | Hydroxychloroquine and Folic Acid | 65 | |
| Overall Study | Completed Enrollment | Hydroxychloroquine and Azithromycin | 74 | |
| Overall Study | Completed Enrollment | Lopinavir-ritonavir | 27 | |
| Overall Study | Completed Enrollment | Ascorbic Acid | 28 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events45
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 | Event leading to treatment discontinuation | Gastrointestinal disorders | Ascorbic Acid and Folic Acid | 2 | 83 | 2 |
| other | Event leading to treatment discontinuation | Gastrointestinal disorders | Hydroxychloroquine and Folic Acid | 1 | 71 | 1 |
| other | Event leading to treatment discontinuation | Gastrointestinal disorders | Hydroxychloroquine and Azithromycin | 3 | 77 | 4 |
| other | Event leading to treatment discontinuation | Gastrointestinal disorders | Lopinavir-ritonavir | 9 | 29 | 13 |
| other | Event leading to treatment discontinuation | Gastrointestinal disorders | Ascorbic Acid | 0 | 29 | 0 |
| other | QT Prolongation | Cardiac disorders | Ascorbic Acid and Folic Acid | 0 | 83 | 0 |
| other | QT Prolongation | Cardiac disorders | Hydroxychloroquine and Folic Acid | 2 | 71 | 2 |
| other | QT Prolongation | Cardiac disorders | Hydroxychloroquine and Azithromycin | 0 | 77 | 0 |
| other | QT Prolongation | Cardiac disorders | Lopinavir-ritonavir | 0 | 29 | 0 |
| other | QT Prolongation | Cardiac disorders | Ascorbic Acid | 0 | 29 | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ascorbic Acid and Folic Acid | 0 | 83 |
| Total, all-cause mortality | Hydroxychloroquine and Folic Acid | 0 | 71 |
| Total, all-cause mortality | Hydroxychloroquine and Azithromycin | 0 | 77 |
| Total, all-cause mortality | Lopinavir-ritonavir | 0 | 29 |
| Total, all-cause mortality | Ascorbic Acid | 0 | 29 |
| Total, other adverse events | Ascorbic Acid and Folic Acid | 2 | 83 |
| Total, other adverse events | Hydroxychloroquine and Folic Acid | 4 | 71 |
| Total, other adverse events | Hydroxychloroquine and Azithromycin | 5 | 77 |
| Total, other adverse events | Lopinavir-ritonavir | 9 | 29 |
| Total, other adverse events | Ascorbic Acid | 0 | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT04354428
GET https://conductscience.org/api/trials/v1/NCT04354428/results?page=2