Trial · NCT04673214
Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
NCT04673214, Phase 3, Completed, Gilberto Cruz Arteaga; results first posted 2021-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment. Trials, record NCT04673214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04673214
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
- NCT number
- NCT04673214
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 114 participants, actual
- Lead sponsor
- Gilberto Cruz Arteaga
- Conditions
- Covid19
- Interventions
- Azithromycin / Ivermectin / Ribaroxaban / Paracetamol, Azithromycin / Ribaroxaban / Paracetamol
- First posted
- 2020-12-17
- Last updated
- 2021-08-16
- Results first posted
- 2021-08-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | 14 days | Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy. |
| Primary | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | 14 days | Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables. |
| Other | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | 14 days | Statistical differences were evaluated using Student's t test for quantitative variables. The average duration of days with clinical symptoms of COVID-19 under early intervention treatment by outcome in the improvement of the modification of the clinical evolution of symptoms vs. therapeutic failure. |
| Other | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | 14 days | Survival analysis. The time it takes for 50% of COVID-19 patients to improve symptoms during a 14-day follow-up with dual therapy vs. triple therapy |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | 14 days | Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis. | days | MEAN |
| PRIMARY | Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS | 14 days | Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS | 14 days | Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20% | Days | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up | 14 days | Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | DOUBLE THERAPY | Cough | 7 | Standard Deviation 5.4 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | TRIPLE THERAPY | Cough | 7 | Standard Deviation 5.6 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | DOUBLE THERAPY | Fever | 2 | Standard Deviation 3.4 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | TRIPLE THERAPY | Fever | 2 | Standard Deviation 3.2 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | DOUBLE THERAPY | Headache | 6 | Standard Deviation 5.2 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | TRIPLE THERAPY | Headache | 5 | Standard Deviation 4.9 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | DOUBLE THERAPY | Rhinorrhea | 3 | Standard Deviation 4.8 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | TRIPLE THERAPY | Rhinorrhea | 3 | Standard Deviation 4.3 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | DOUBLE THERAPY | Odynophagia | 5 | Standard Deviation 4.8 | days |
| Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | TRIPLE THERAPY | Odynophagia | 5 | Standard Deviation 5.4 | days |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triple Therapy | 67 | |
| Overall Study | STARTED | Double Therapy | 47 | |
| Overall Study | Lost to Follow up | Triple Therapy | 2 | |
| Overall Study | Lost to Follow up | Double Therapy | 1 | |
| Overall Study | COMPLETED | Triple Therapy | 65 | |
| Overall Study | COMPLETED | Double Therapy | 46 | |
| Overall Study | NOT COMPLETED | Triple Therapy | 2 | |
| Overall Study | NOT COMPLETED | Double Therapy | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | asthenia | Skin and subcutaneous tissue disorders | Dual Therapy Adverse Event | 24 | 46 | 24 |
| other | asthenia | Skin and subcutaneous tissue disorders | Adverse Event Triple Therapy | 18 | 65 | 18 |
| other | Palpitations | Cardiac disorders | Dual Therapy Adverse Event | 4 | 46 | 4 |
| other | Palpitations | Cardiac disorders | Adverse Event Triple Therapy | 5 | 65 | 5 |
| other | Tinnitus | Ear and labyrinth disorders | Dual Therapy Adverse Event | 6 | 46 | 6 |
| other | Tinnitus | Ear and labyrinth disorders | Adverse Event Triple Therapy | 10 | 65 | 10 |
| other | Nausea | Gastrointestinal disorders | Dual Therapy Adverse Event | 9 | 46 | 9 |
| other | Nausea | Gastrointestinal disorders | Adverse Event Triple Therapy | 18 | 65 | 18 |
| other | Ecchymosis | Blood and lymphatic system disorders | Dual Therapy Adverse Event | 2 | 46 | 2 |
| other | Ecchymosis | Blood and lymphatic system disorders | Adverse Event Triple Therapy | 2 | 65 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dual Therapy Adverse Event | 1 | 46 |
| Total, all-cause mortality | Adverse Event Triple Therapy | 2 | 65 |
| Total, other adverse events | Dual Therapy Adverse Event | 39 | 46 |
| Total, other adverse events | Adverse Event Triple Therapy | 49 | 65 |
| Total, serious adverse events | Dual Therapy Adverse Event | 0 | 46 |
| Total, serious adverse events | Adverse Event Triple Therapy | 0 | 65 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dual Therapy Adverse Event vs Adverse Event Triple Therapy: deaths from any cause | Trial comparisons |
| Dual Therapy Adverse Event vs Adverse Event Triple Therapy: serious adverse events | Trial comparisons |
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.
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