Trial · NCT04803227
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 14 Days | Incidence rate of related treatment-emergent adverse events |
| Secondary | Patient reported outcomes as assessed by COVID-19 assessment tool | At screening/randomization, daily televisits (Day 2 - Day 13), Day 14, Day 30 and Day 45 | The 2020 FDA Guidance for Industry Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment is the PRO that will be used for the study. |
| Secondary | Number of participants that experience death during the study. | 45 Days | Rate of mortality events |
| Secondary | Number of participants the experience a related serious adverse event as assessed by CTCAE v5.0. | 45 Days | Cumulative incidence rate of related serious adverse events |
| Secondary | Number of participants that experiences a Grade 3 and 4 adverse event as assessed by CTCAE v5.0 | 45 Days | Cumulative incidence rate of Grade 3 and 4 adverse events |
| Secondary | Number of participants with a discontinuation or temporary suspension of study drug | 45 days | Each participant that discontinues or temporarily suspends study drug for any reason. |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 1, Day 14, Day 30 and Day 45 | Each participant will be assessed via performance of standard of care hematology and biochemistry labs. The results of the labs will be assessed against a set of normal ranges for the CLIA certified laboratory. |
| Secondary | Each participant will be tested for SARS-CoV-2 viral eradication via a sample from the nasopharynx and the sample will be tested via RT- PCR. | Days 14, 30 and 45 | SARS-CoV-2 viral eradication from nasopharynx at end of treatment. |
| Secondary | Each participant will perform a 6 minute walk test (6MWD) for distance (400-700m) walked. | Days 14, 30 and 45 | Perform 6 Minute Walk Test |
| Secondary | Each participant will be assessed for COVID-19 severity via an 8-point ordinal scale | Days 14, 30 and 45 | COVID-19 severity score on the 8-point COVID-19 Severity Scale. Scores are from 1 to 8, where 1 = uninfected and 8 = death |
| Secondary | Each participant will be tested for anti-SARS-CoV-2 neutralizing antibodies via standard histogram, 2D plots, tSNE, and viSNE analysis. | Days 14, 30 and 45 | The following cell populations will be examined- NK, CD4 and CD8 T-cells, Tfh, Treg, CD4 and CD8 memory, B-cell memory, monocytes and dendritic cells. |
| Secondary | Each participant will be tested for anti-SARS-CoV-2 quantitative antibodies via cytokine test panel. | Days 14, 30 and 45 | Immune test for titers of serum anti-SARS-CoV-2 quantitative antibodies |
| Secondary | Each participant will be assessed for resolution of COVID19 symptoms via performance of hematology and biochemistry labs, SARS-COV-2 nasopharyngeal swab and tested via RT-PCR and immunology testing for cytokines and cell populations. | Days 14, 30 and 45 | Percentage of Participants with Resolution of COVID19 symptoms |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04803227/registered